Posts

Posted on

ChowChow Cloud International Holdings Limited Provides Response to Unusual Market Action

SINGAPORE, Aug. 29, 2026 (GLOBE NEWSWIRE) — ChowChow Cloud International Holdings Limited (“Chowchow”, the “Company”) (NYSE American: CHOW) announced today that the Company had become aware of unusual trading activity in its ordinary shares on the NYSE American LLC (the “NYSE American”) on August 12, 2026 and August 27, 2026. The Company is issuing this press release pursuant to Section 401(d) of the NYSE American Company Guide. The Company has made inquiries and has been unable to determine whether corrective actions are appropriate at this time. The Company is further announcing that there has been no material development in its business and affairs not previously disclosed or, to its knowledge, any other reason to account for the unusual market action.

About ChowChow Cloud International Holdings Limited

ChowChow Cloud is a pioneer in providing one-stop cloud solutions that support companies across the IT industry value chain throughout their entire cloud transformation journey from consulting, deployment and migration to cloud environment building and management. ChowChow Cloud was founded in December 2014 by a group of passionate and experienced professionals, who envisioned the potential of cloud technology to transform the way businesses of various sizes operate. Recognizing the growing need for digitization and the benefits that cloud technology could bring to businesses, ChowChow Cloud’s founders set out to create a company that would bridge the gap between cloud services providers and companies who seek to move to the cloud.

Forward-looking Statements

This release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements give our current expectations, opinion, belief or forecasts of future events and performance. A statement identified by the use of forward-looking words including “will,” “may,” “expects,” “projects,” “anticipates,” “plans,” “believes,” “estimate,” “should,” and certain of the other foregoing statements may be deemed forward-looking statements. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including market and other conditions. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company undertakes no obligation to update any such forward-looking statements after the date hereof to conform to actual results or changes in expectations, except as required by law.

For more information, please contact:

Investor Relations Team
ChowChow Cloud International Holdings Limited
Email: [email protected] 



Posted on

Bristol Myers Squibb Presents Data Up to Five Years Reinforcing the Long-Term Efficacy and Safety of Camzyos (mavacamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) at the European Society of Cardiology (ESC) Congress 2026

Bristol Myers Squibb Presents Data Up to Five Years Reinforcing the Long-Term Efficacy and Safety of Camzyos (mavacamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) at the European Society of Cardiology (ESC) Congress 2026

New single-arm, open-label data extend the body of evidence supporting consistent clinical benefit and safety with Camzyos, adding to the longest-running clinical development experience for a cardiac myosin inhibitor (CMI) in symptomatic oHCM

Additional presentations at ESC Congress build upon the established effectiveness and safety profile of Camzyos in real-world settings

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today presented results from the EXPLORER-LTE cohort of the MAVA-LTE study (NCT03723655) in a late-breaker presentation at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany. EXPLORER-LTE is the largest and longest evaluation of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) patients treated with Camzyos, the most-studied cardiac myosin inhibitor (CMI) and a standard of care for patients with oHCM in New York Heart Association (NYHA) class II-III. These data add to the understanding that the effects of Camzyos are sustained for up to five years with continuous, consistent treatment. Additional presentations at ESC Congress from COLLIGO-HCM, a global retrospective real-world data study, add to the well-established real-world evidence supporting Camzyos, helping inform treatment decisions for people living with the condition.

“The EXPLORER-LTE data up to five years reflect the sustained and clinically meaningful effects of Camzyos for patients living with symptomatic oHCM,” said Anjali T. Owens, MD, Medical Director of the Center for Inherited Cardiac Disease and an Associate Professor of Medicine in the Perelman School of Medicine at the University of Pennsylvania. “For a chronic, progressive condition that requires ongoing treatment and monitoring, long-term evidence is essential to helping clinicians better understand how a therapy may benefit patients over time.”

EXPLORER-LTE is a single-arm, open-label, dose-blinded extension of the Phase 3 EXPLORER-HCM study, evaluating the long-term safety and efficacy of Camzyos. A total of 231 patients who completed EXPLORER-HCM enrolled in the long-term extension study. A substantial portion of patients experienced sustained and clinically meaningful reduction of left ventricular outflow tract (LVOT) obstruction, improved by at least one NYHA class and experienced notable improvements in echocardiographic measures and biomarkers. No new safety signals were observed that were not observed in the primary EXPLORER-HCM study.

At 252 weeks, Camzyos treatment resulted in mean changes from baseline at initiation of the long-term extension study of -38.7 mm Hg for resting LVOT gradient and -55.6 mm Hg in Valsalva LVOT gradient. Nearly all patients (97.4%) achieved a Valsalva LVOT gradient ≤ 30 mm Hg, which is the threshold for obstruction in patients with oHCM. 69.6% of patients improved by ≥1 NYHA class and 59.2% of patients were asymptomatic. Mean left ventricular ejection fraction (LVEF) decreased by 10.2% and remained within the normal range. Safety findings were consistent with reported results from the primary EXPLORER-HCM study.

Additional data presented at ESC Congress further support Camzyos and our understanding of the impact of oHCM. Two presentations from COLLIGO-HCM, a global retrospective real-world data study, added to the well-established real-world evidence supporting Camzyos in clinical practice, with a real-world effectiveness and safety profile that is consistent across patients, providing symptom improvement and reduction in LVOT obstruction. A complementary analysis of a real-world observational registry study in Germany reinforces the effectiveness of Camzyos across geographic populations, with patients achieving NYHA class reductions consistent with previously reported real-world studies. These findings build on the existing evidence base for Camzyos and reinforce that the improvements seen in clinical trials are also achieved in real-world settings. An additional analysis of a healthcare resource utilization (HCRU) study in Sweden adds to the understanding of the broader disease burden of HCM and oHCM, including the increased impact of oHCM, and emphasizes the importance of accurate diagnosis and consistent care for patients living with oHCM.

“For people living with symptomatic oHCM, long-term and real-world evidence provides greater confidence in treatment decisions and a clearer understanding of what sustained therapy may mean over time,” said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. “As part of our dedication to advancing cardiovascular research, the data presented at ESC Congress add to the understanding and trust of Camzyos and its role in helping patients manage oHCM, a serious condition affecting daily activities for many patients.”

Camzyos is supported by the largest body of worldwide evidence in the CMI treatment class, reinforcing its role in transforming care for symptomatic oHCM by improving functional capacity and symptoms, allowing patients to be more active in their daily lives.

About EXPLORER-LTE

EXPLORER-LTE, a cohort of the MAVA-LTE study (NCT03723655), is a single-arm, open-label, dose-blinded extension of the Phase 3 EXPLORER-HCM study evaluating the long-term safety and efficacy of Camzyos. A total of 231 patients in the United States, Europe and Israel who completed EXPLORER-HCM enrolled in the long-term extension study.

About CAMZYOS® (mavacamten)

CAMZYOS® (mavacamten) is the most extensively studied cardiac myosin inhibitor (CMI), approved by regulatory bodies in more than 60 countries and regions across five continents worldwide. In the U.S., CAMZYOS is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. In the European Union, CAMZYOS is indicated for the treatment of symptomatic (NYHA, class II-III) oHCM in adult patients.

A selective, reversible, allosteric inhibitor of cardiac myosin, CAMZYOS targets hypercontractility, the source of oHCM. Reduction in cardiac contractility with CAMZYOS treatment leads to reduced LVOT obstruction, improved energy consumption, and lower cardiac filling pressures in oHCM patients. These effects have translated to demonstrated symptom improvements in clinical studies for adults with symptomatic oHCM, enabling them to be more active in their daily lives. CAMZYOS can be used with or without background therapies, including for newly diagnosed patients.

CAMZYOS is supported by the largest body of worldwide evidence in the CMI treatment class, with up to five years of follow up across multiple long-term evidence and real-world studies, demonstrating the consistent and sustained benefits of CAMZYOS to improve symptoms and impact cardiac structure. CAMZYOS has been prescribed by more than 5,000 healthcare providers (HCPs) to over 25,000 patients in the U.S. alone.

Bristol Myers Squibb: Changing the Course of Cardiovascular Disease

Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. Cardiovascular disease is the leading cause of death worldwide, and despite major advances in how we prevent and treat it, the human and societal burden continues to worsen over time. Whether a cardiovascular disease that affects millions of people around the world, or a rarer condition, the need is the same: new and better treatment options that allow people to continue to live their fullest lives.

Bristol Myers Squibb is committed to developing new treatments to address the global burden of cardiovascular disease. Building on our 70-year legacy of discovering and delivering paradigm-changing cardiovascular medicines, we are leveraging our experience and expertise, to take cardiovascular research to the next level and delivering meaningful, life‑changing outcomes for patients.

CAMZYOS U.S. IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILURE

CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following:

  • Strong CYP2C19 inhibitors
  • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called CAMZYOS REMS PROGRAM.

CONTRAINDICATIONS

CAMZYOS is contraindicated with concomitant use of:

  • Strong CYP2C19 inhibitors

  • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

WARNINGS AND PRECAUTIONS

Heart Failure

CAMZYOS reduces systolic contraction and can cause heart failure or significantly reduce ventricular function. Patients who experience a serious intercurrent illness (e.g., serious infection) or arrhythmia (e.g., atrial fibrillation or other uncontrolled tachyarrhythmia) are at greater risk of developing systolic dysfunction and heart failure.

Assess the patient’s clinical status and LVEF prior to and regularly during treatment and adjust the CAMZYOS dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, palpitations, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of heart failure and should also prompt an evaluation of cardiac function.

Asymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional dosing considerations.

Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.

CYP450 Drug Interactions Leading to Heart Failure or Loss of Effectiveness

CAMZYOS is primarily metabolized by CYP2C19 and CYP3A4 enzymes. Concomitant use of CAMZYOS and drugs that interact with these enzymes may lead to life-threatening drug interactions such as heart failure or loss of effectiveness.

Advise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). Advise patients to inform their healthcare provider of all concomitant products prior to and during CAMZYOS treatment.

CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program

CAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction. Notable requirements of the CAMZYOS REMS Program include the following:

  • Prescribers must be certified by enrolling in the REMS Program

  • Patients must enroll in the REMS Program and comply with ongoing monitoring requirements

  • Pharmacies must be certified by enrolling in the REMS Program and must only dispense to patients who are authorized to receive CAMZYOS

  • Wholesalers and distributors must only distribute to certified pharmacies

Further information is available at www.CAMZYOSREMS.com or by telephone at 1-833-628-7367.

Embryo-Fetal Toxicity

CAMZYOS may cause fetal toxicity when administered to a pregnant female, based on findings in animal studies. Confirm absence of pregnancy in females of reproductive potential prior to treatment and advise patients to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. Combined hormonal contraceptives (CHCs) containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.

ADVERSE REACTIONS

In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). There were no new adverse reactions identified in VALOR-HCM.

Effects on Systolic Function

In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.

DRUG INTERACTIONS

Potential for Other Drugs to Affect Plasma Concentrations of CAMZYOS

CAMZYOS is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4 and CYP2C9. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of CAMZYOS.

Impact of Other Drugs on CAMZYOS:

  • Strong CYP2C19 Inhibitors: Concomitant use increases CAMZYOS exposure, which may increase the risk of heart failure due to systolic dysfunction. Concomitant use is contraindicated.
  • Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers: Concomitant use decreases CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes. Concomitant use is contraindicated.
  • Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors: Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Initiate CAMZYOS at the recommended starting dose of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 to 10 mg, 10 to 5 mg, or 5 to 2.5 mg) in patients who are on CAMZYOS treatment and intend to initiate a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Schedule clinical and echocardiographic assessment 4 weeks after inhibitor initiation, and do not up-titrate CAMZYOS until 12 weeks after inhibitor initiation. Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available. For short-term use (eg, 1 week), interrupt CAMZYOS for the duration of treatment with a weak inhibitor of CYP2C19 or a moderate inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy.
  • Moderate CYP2C19 Inhibitors or Strong CYP3A4 Inhibitors: Concomitant use with a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Discontinuing use of a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor after long-term concomitant use may decrease CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. Initiate CAMZYOS at a starting dosage of 2.5 mg orally once daily in patients who are on a stable therapy with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 to 10 mg, 10 to 5 mg, or 5 to 2.5 mg) in patients who are on CAMZYOS and intend to initiate a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Avoid initiation of concomitant moderate CYP2C19 and strong CYP3A4 inhibitors in patients who are on a stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available. An increase in dose of CAMZYOS may be needed if the moderate inhibitor of CYP2C19 or strong inhibitor of CYP3A4 is discontinued after long-term concomitant use. Monitor for new or worsening symptoms. For short-term use (ie, when CAMZYOS dose modification is not feasible), interrupt CAMZYOS for the duration of treatment with a moderate inhibitor of CYP2C19 or a strong inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy.

Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs

CAMZYOS is an inducer of CYP3A4, CYP2C9, and CYP2C19. Concomitant use with CYP3A4, CYP2C9, or CYP2C19 substrates may reduce plasma concentration of these drugs. Closely monitor when CAMZYOS is used with concomitant CYP3A4, CYP2C9, or CYP2C19 substrates unless otherwise recommended in the Prescribing Information.

Certain Combined Hormonal Contraceptives (CHCs): Progestin and ethinyl estradiol are CYP3A4 substrates. Concomitant use of CAMZYOS may decrease exposures of certain progestins, which may lead to contraceptive failure. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS, but if other CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method that is not affected by CYP450 enzyme induction (eg, intrauterine system) during concomitant use and for 4 months after the last dose of CAMZYOS.

Drugs That Reduce Cardiac Contractility

Expect additive negative inotropic effects of CAMZYOS and other drugs that reduce cardiac contractility. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.

If concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved.

SPECIFIC POPULATIONS

Pregnancy

Based on animal data, CAMZYOS may cause fetal harm when administered to a pregnant female. Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. There is a pregnancy safety study for CAMZYOS. If CAMZYOS is administered during pregnancy, or if a patient becomes pregnant while receiving CAMZYOS or within 4 months after the last dose of CAMZYOS, healthcare providers should report CAMZYOS exposure by contacting Bristol Myers Squibb at 1-800-721-5072 or www.bms.com.

Lactation

The presence of CAMZYOS in human or animal milk, the drug’s effects on the breastfed infant, or the effects on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CAMZYOS and any potential adverse effects on the breastfed child from CAMZYOS or from the underlying maternal condition.

Females and Males of Reproductive Potential

Confirm absence of pregnancy in females of reproductive potential prior to initiation of CAMZYOS. Advise females of reproductive potential to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method during concomitant use and for 4 months after the last dose of CAMZYOS.

Please see U.S. Full Prescribing Information, including Boxed WARNING and Medication Guide.

About Bristol Myers Squibb: Transforming Patients’ Lives Through Science

At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that results of future post-marketing studies will be consistent with the results of this study, that Camzyos (mavacamten), may not be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of Camzyos may be contingent upon verification and description of clinical benefit in additional confirmatory trials. No forward-looking statement can be guaranteed. It should be noted that acceptance of the application does not change the standards for FDA approval. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

corporate financial-news

Bristol Myers Squibb

Media Inquiries:

[email protected]

Investors:

[email protected]

KEYWORDS: New Jersey Germany Europe United States North America

INDUSTRY KEYWORDS: Research Clinical Trials Cardiology Other Health Biotechnology General Health Pharmaceutical Health Science Other Science

MEDIA:

Logo
Logo
Posted on

Cytokinetics Announces Additional Results from ACACIA-HCM and MAPLE-HCM Presented in Late Breaking Clinical Trial Session at the European Society of Cardiology (ESC) Congress 2026

Additional Results from ACACIA-HCM Demonstrate Improvements in 
Cardiac Structure and Diastolic Function in Patients with Non-Obstructive HCM

New Analysis of MAPLE-HCM Finds Aficamten Outperformed Metoprolol Across Pre-Trial Treatment Groups in Patients with Obstructive HCM

SOUTH SAN FRANCISCO, Calif., Aug. 29, 2026 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional results from ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM) and MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM) were presented in a Late Breaking Clinical Session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany and simultaneously published in Circulation and the Journal of the American College of Cardiology: Heart Failure, respectively.

“The findings from these additional analyses of ACACIA-HCM and MAPLE-HCM elaborate on the primary results from each trial and expand the body of evidence supporting the potential use of aficamten across the spectrum of HCM,” said Stephen Heitner, M.D., Cytokinetics’ Chief Medical Officer. “In particular, the additional results from ACACIA-HCM suggest that the benefits of aficamten in non-obstructive HCM extend beyond exercise capacity and symptom burden to also include improvements in wall thickness and diastolic function, pointing to the potential mechanisms by which aficamten is effective in these patients. Given the lack of approved therapies for non-obstructive HCM, these findings highlight the potential impact aficamten could have on this population independent from relief of left ventricular outflow tract obstruction.”

ACACIA-HCM: Effect of

Aficamten

on Cardiac Structure and Function in Patients with Symptomatic Non-Obstructive HCM

Results from a pre-specified exploratory analysis of ACACIA-HCM, the Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), were presented in a Late Breaking Clinical Trial Session and simultaneously published in Circulation.1

As previously reported, the primary results from ACACIA-HCM showed that treatment with aficamten was associated with significant improvements from baseline to Week 36 compared to placebo in both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and maximal exercise performance (pVO2). This analysis showed that treatment with aficamten also demonstrated improvements in measures of cardiac structure and diastolic function at the time of the primary analysis (36 weeks) and at end of treatment (EOT) (up to 72 weeks; median time to end of treatment = 49 weeks).

At Week 36 and at EOT, aficamten significantly improved measures of diastolic function including peak E velocity (p=0.001 and p=0.034, respectively) and septal e’ velocity (p<0.001 for both), suggesting improvement in myocardial relaxation and enhanced early diastolic filling. Septal E/e’ showed a trend towards improvement at Week 36 (p=0.07), and a statistically significant improvement at EOT (p<0.001). Similarly, left atrial volume index (LAVI) showed a trend toward stabilization at Week 36 (p=0.06) and a statistically significant improvement with longer treatment exposure at EOT (p=0.022). These results in patients with nHCM show that aficamten improves diastolic function independent of reducing left ventricular outflow tract (LVOT) obstruction, providing support for the importance of diastolic function as the potential underlying mechanism for the improvements in functional capacity and symptom relief in this population.

Aficamten was associated with a modest but statistically significant (p<0.001) reduction in systolic function as measured by left ventricular ejection fraction (LVEF) which remained within normal range at EOT. Left ventricular wall thickness decreased by 0.2 cm at EOT (p<0.001) while left ventricular end-systolic and end-diastolic left ventricular volumes increased (p<0.001).

MAPLE-HCM:

Aficamten

vs.

Metoprolol

in Obstructive HCM According to Pre-Trial Treatment

Results of a post-hoc analysis from MAPLE-HCM, the Phase 3 clinical trial of aficamten compared to metoprolol in patients (n=175) with symptomatic obstructive HCM (oHCM), were presented in a Late Breaking Clinical Trial Session and simultaneously published in the Journal of the American College of Cardiology: Heart Failure.2

As previously reported, the primary results of MAPLE-HCM demonstrated superiority of aficamten to metoprolol on pVO2 (change from baseline to Week 24, least squares mean (LSM) treatment difference (SE), +2.3 (0.39) mL/kg/min, p<0.001). This post-hoc analysis evaluated the effect of treatment with aficamten or metoprolol on the primary endpoint and key secondary endpoints according to pre-trial medical therapy.

At screening, 123 patients were taking a beta blocker while 52 patients were not taking a beta blocker. Of the 52 patients not taking a beta blocker at screening, 22 patients had received no standard of care therapy for at least 12 months before screening. Prior to randomization, all patients underwent a two-week washout period of standard of care therapy.

Independent of pre-trial medical therapy, aficamten demonstrated a consistent treatment effect across multiple efficacy endpoints compared with metoprolol. Aficamten improved pVO2 compared with metoprolol for patients not previously taking beta blockers (LSM difference +3.1 mL/kg/min, p<0.001), as well as for patients previously taking beta blockers (LSM difference +1.9 mL/kg/min, p<0.001) with no difference between groups in the improvement (interaction p = 0.133).

Similarly, compared to metoprolol, aficamten significantly improved key secondary endpoints independent of pre-trial treatment, including KCCQ-CSS and New York Heart Association (NYHA) Functional Class, Valsalva left ventricular outflow tract gradient (LVOT-G) and NT-proBNP.

There were no differences in the safety profile of aficamten, including the rates of serious adverse events, between pre-trial treatment groups.

About ACACIA-HCM

ACACIA-HCM was a Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of aficamten compared to placebo in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). The dual primary endpoint was the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score and change in maximal exercise performance (peak VO2) from baseline to Week 36.

Secondary endpoints included the proportion of participants with ≥1 class improvement in NYHA functional class, and changes in the composite z-score of two cardiopulmonary exercise testing (CPET) parameters of sub-maximal exercise performance (VE/VCO2 and pVO2), NT-proBNP, and left atrial volume index (LAVI) from baseline to Week 36. After 36 weeks of treatment, participants continued treatment with aficamten or placebo for up to 72 weeks to evaluate additional secondary and exploration analyses including the time to first cardiovascular event. The trial (outside Japan) concluded when at least 200 patients completed 52 weeks of treatment.

ACACIA-HCM randomized and treated 517 participants (outside Japan) on a 1:1 basis with aficamten or placebo. Randomization was stratified by persistent atrial fibrillation and presence of intracavitary obstruction. At screening, participants enrolled in ACACIA-HCM were required to have resting left ventricular outflow tract gradient (LVOT-G) <30 mmHg and post-Valsalva LVOT-G <50 mmHg in addition to left ventricular ejection fraction (LVEF) ≥60%, respiratory exchange ratio (RER) ≥1.00 and peak VO2 ≤90% predicted, NT-proBNP ≥300 pg/mL or ≥900 pg/mL if atrial fibrillation or atrial flutter were present at screening, NYHA functional class II or III and KCCQ Clinical Summary Score ≤85.

Each patient received up to four escalating doses of aficamten or placebo based on echocardiographic guidance. Participants who received aficamten began with 5 mg dosed once daily. At weeks 2, 4 and 6 participants received an echocardiogram to determine if they would be up-titrated to escalating doses of 10, 15 or 20 mg. Dose escalation occurred only if a participant had an LVEF ≥60%. Participants who did not meet escalation criteria continued the same dose or were down-titrated if their LVEF was <50%.

About MAPLE-HCM

MAPLE-HCM was a Phase 3, multi-center, randomized, double-blind active-comparator clinical trial of aficamten compared to metoprolol in patients with symptomatic obstructive HCM (oHCM). The primary endpoint was the change in peak oxygen uptake (pVO2) from baseline to Week 24 measured by cardiopulmonary exercise testing (CPET). Secondary endpoints include the change from baseline to Week 24 in Kansas City Cardiomyopathy Questionnaire (KCCQ) score, the proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) functional class, and changes in left ventricular mass index (LVMI), left atrial volume index (LAVI), post-Valsalva left ventricular outflow tract gradient (LVOT-G) and NT-proBNP.

MAPLE-HCM enrolled 175 patients, randomized on a 1:1 basis to receive aficamten or metoprolol as monotherapy in a double-blind, double dummy fashion. Randomization was stratified by CPET exercise modality (treadmill or bicycle) and recently diagnosed versus chronic obstructive HCM. At screening, patients enrolled in MAPLE-HCM had a resting LVOT-G ≥30 mmHg and/or post-Valsalva LVOT-G ≥50 mmHg in addition to left ventricular ejection fraction (LVEF) ≥ 60%, respiratory exchange ratio (RER) ≥ 1.05 and pVO2 <100% predicted, NYHA functional class II or III and a KCCQ Clinical Summary Score (KCCQ-CSS) score ≥ 35 and ≤ 90. Following the initial screening visit, all participants on standard of care (SOC) therapy underwent a washout period of up to 14 days to wean from SOC therapy, followed by an additional 7 days with no SOC therapy prior to the second screening visit. Each patient received up to four escalating doses of aficamten or metoprolol based on echocardiographic guidance as well as a matching placebo for the alternate therapy.

About MYQORZO® (

aficamten

)

MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union and United Kingdom for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. MYQORZO was engineered to achieve a predictable exposure response, rapid onset of action and reversibility.3

Aficamten is also under clinical investigation in CEDAR-HCM in a pediatric population with oHCM. Safety and efficacy of aficamten have not been established in a pediatric patient population. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study.

INDICATION

MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILURE

MYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF is <50% and ≥40%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction

.

Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program.



CONTRAINDICATIONS

MYQORZO is contraindicated with concomitant use of rifampin.

WARNINGS AND PRECAUTIONS

Heart Failure

MYQORZO reduces cardiac contractility, which can reduce LVEF and cause heart failure.
Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, new or uncontrolled atrial fibrillation) may be at greater risk of developing systolic dysfunction and heart failure.

Assess patients’ clinical status and LVEF prior to and during treatment and adjust the MYQORZO dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide may be signs and symptoms of heart failure.

Initiation of MYQORZO in patients with LVEF <55% is not recommended.

MYQORZO REMS Program

MYQORZO is available only through a restricted program called the MYQORZO REMS Program, because of the risk of heart failure due to systolic dysfunction.

Notable requirements of the MYQORZO REMS Program include:

  • Prescribers must be certified by enrolling in the MYQORZO REMS Program
  • Patients must enroll in the MYQORZO REMS Program and comply with ongoing monitoring requirements
  • Pharmacies must be certified by enrolling in the MYQORZO REMS Program and must only dispense to patients who are authorized to receive MYQORZO
  • Wholesalers and distributors must only distribute to certified pharmacies

Further information is available at www.MYQORZOREMS.com, or at 1-844-285-7367.

Cytochrome P450 Interactions Leading to Heart Failure or Loss of Effectiveness

MYQORZO is metabolized primarily by CYP2C9, and to a lesser extent by CYP3A, CYP2D6, and CYP2C19 enzymes. Initiation of medications that inhibit multiple P450 pathways of MYQORZO elimination (eg, fluconazole, voriconazole, or fluvoxamine) or strong CYP2C9 inhibitors, and discontinuation of moderate-to-strong CYP3A inducers may lead to increased blood concentrations of aficamten and increase the risk of heart failure due to systolic dysfunction. Conversely, initiation of medications that induce P450 pathways of MYQORZO (eg, rifampin, moderate-to-strong CYP3A inducers) may lead to decreased blood concentrations of aficamten and potential loss of effectiveness. Assess LVEF 2 to 8 weeks after initiation of such inhibitors or after discontinuation of such inducers and adjust the dose of MYQORZO accordingly.

Advise patients of the potential for drug interactions. Advise patients to inform their healthcare provider of all concomitant medications prior to and during MYQORZO treatment.

ADVERSE REACTIONS

Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% of patients and more commonly on MYQORZO than on placebo in the pivotal trial.

INDICATIONS AND USAGE

MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

Please see full Prescribing Information approved in the U.S., including Boxed WARNING.

Please see full Summary of Product Characteristics approved in the European Union.

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thick. HCM can be obstructive, when thickened muscle blocks blood flow, or non-obstructive, when blood flow is not blocked but heart function is still affected. In obstructive HCM, the thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller, stiffer and less able to relax and fill with blood. Ultimately, HCM limits the heart’s pumping function, leading to reduced exercise capacity and a variety of symptoms.

HCM is the most common monogenic inherited cardiovascular disorder, affecting approximately 1 out of 350 individuals worldwide.4

Approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM).5

People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.6 People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes.7 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation.

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the approved in the U.S., China, European Union and United Kingdom for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to our ability to obtain regulatory approval for aficamten in nonobstructive hypertrophic cardiomyopathy in any jurisdiction by any particular date, if ever, the number of patients comprising the eligible treatment population for aficamten, or market acceptance of aficamten for the treatment of nonobstructive hypertrophic cardiomyopathy. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.

CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S., the European Union and the United Kingdom.

References

  1. Maron MS, et al. Global Efficacy of Aficamten in Nonobstructive Hypertrophic Cardiomyopathy: Results From ACACIA-HCM. Circ. 2026
  2. Dominguez, F. Efficacy of Aficamten vs Metoprolol According to Pretrial Beta-Blocker Treatment in Obstructive Hypertrophic Cardiomyopathy. JACC: HF. 2026.
  3. Maron, MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. doi:10.1056/NEJMoa2401424
  4. Tsenov et al. Healthcare access, symptom burden, and psychological impact in hypertrophic cardiomyopathy: a multinational patient-driven survey. Int J Cardiol Cardiovasc Risk Prev2025 Aug 4;27:200485. doi: 10.1016/j.ijcrp.2025.200485
  5. Butzner M, et al. Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023. JACC Adv. 2026. 2026;5(2):102552. doi:10.1016/j.jacadv.2025.102552
  6. Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260.
  7. Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757



Posted on

Tenax Therapeutics Announces Presentation of Phase 3 LEVEL Results in Late-Breaking Scientific Sessions at ESC Congress 2026

In patients with a baseline 6MWD below the trial median of 333 meters, treatment with TNX-103 resulted in a 26.3-meter improvement compared to placebo (p = 0.0112)

In the same patient population, TNX-103 produced a 47% reduction in NT-proBNP (p < 0.0001) and a 4.9 mmHg reduction in RVSP (p = 0.009) compared to placebo

With full statistics analysis now complete, Company confirms TNX-103’s biological effects include marked reductions in pulmonary artery pressure and NT-proBNP, a biomarker reflecting increased cardiac wall stress. Results will inform protocol population enrichment and changes to overall registrational path

CHAPEL HILL, N.C., Aug. 29, 2026 (GLOBE NEWSWIRE) — Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”) today announced that additional results from the Phase 3 LEVEL clinical trial evaluating TNX-103 (oral levosimendan) in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) were presented in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany.

Data confirmed findings from prespecified analyses which identified a favorable treatment effect in patients with a lower baseline 6MWD, supported by consistent changes in prespecified endpoints measuring cardiac stress and pulmonary pressures.

“The independent analysis of LEVEL data we presented today sharpens what the earlier topline results initially indicated: patients with the lowest baseline walking distance had the greatest improvement, on top of state-of-the-art background therapy. What was particularly striking was that even patients who did not show a significant improvement in exercise capacity had the same magnitude of reduction in cardiac wall stress and pulmonary artery pressures, changes that correspond to a reduction in heart failure hospitalizations over longer follow-up,” said Sanjiv Shah, MD, Director of the HFpEF Program at Northwestern University Feinberg School of Medicine and LEVEL’s Principal Investigator. “The magnitude of the reduction in NT-proBNP and the accompanying lowering of pulmonary pressure indicate that TNX-103 may provide clinical benefit to the majority of patients with PH-HFpEF independent of its effect on walk distance. The data are compelling and consistently point toward a potential therapeutic benefit in PH-HFpEF patients.”

“The full set of prespecified analyses we completed in the last week, and Dr. Shah’s presentation of the results today, continue to emphasize that the treatment effect of TNX-103 is concentrated in patients walking less than the trial median of 333 meters at baseline. The finding of biologic efficacy in the majority of patients in LEVEL validates that the unique mechanism of action demonstrated in the Phase 2 HELP study can address patient function. That gives us conviction and a clear strategy to enrich LEVEL-2 for a study population of patients in whom the treatment effect is demonstrable,” said Stuart Rich, MD, Chief Medical Officer of Tenax Therapeutics. “LEVEL has been enormously informative in shaping what comes next, and we intend to move quickly on behalf of patients who currently have no approved treatment options.”

Key Takeaways from Late-Breaking Presentation

The Phase 3 LEVEL clinical trial (NCT05983250) randomized 241 patients with PH-HFpEF across 41 sites in the United States and Canada. In this population, the primary endpoint of change in 6-minute walk distance (6MWD) at Week 12 did not achieve statistical significance, nor did the key secondary endpoint, change in Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS); however, marked improvements were noted in exploratory endpoints that demonstrate the biologic effects of the therapy, notably N-terminal pro-B-type natriuretic peptide (NT-proBNP) and right ventricular systolic pressure (RVSP).

Several key observations made in the trial, and their potential influence on the future development of levosimendan for patients with pulmonary hypertension and heart failure, were emphasized:

  • Across the overall trial population (n = 241), TNX-103 was safe and well tolerated, with no significant arrhythmias.
  • This population of older, symptomatic patients presented with multiple comorbidities, and was well-treated on guideline-directed medical therapy (GDMT): across these categories of increasing disease severity, with emphasis placed on atrial fibrillation and exercise tolerance, and increasing therapeutic intervention like MRAs/diuretics, and SGLT-2 inhibitors, levosimendan’s benefit appears to increase.
  • An inverse linear relationship between baseline 6MWD and treatment effect was described and demonstrated not to be explained by regression to the mean. Patients in LEVEL whose baseline 6MWD match those reported in HELP and the recent CADENCE trial with sotatercept (274-285 meters) demonstrated an approximate 20-meter placebo-adjusted improvement in 6MWD. The overall trial population in LEVEL, however, had a median about 50-60 meters higher than in these previous PH-HFpEF trials.
  • Prognostic implications include the impact of levosimendan on NT-proBNP compared to multiple classes of heart failure therapies, including some currently being tested, with commentary of the magnitude of effect in relation to heart failure events. As noted in the presentation, no data from a Phase 3 randomized trial has demonstrated even half the impact on this key indicator of cardiac wall stress, when compared to placebo. In an analysis of the relationship between heart failure outcomes and NT-proBNP change across these classes, Dr. Shah noted that the magnitude of levosimendan’s effect on cardiac wall stress suggests potential impact on outcomes in these HFpEF patients.
  • In addition to RVSP, many echocardiographic endpoints show improvement with levosimendan compared to placebo. Across each domain of echocardiography, approximately 20 echocardiographic parameters improved, even when adjusting for multiple comparisons.

Dr. Shah referenced these results in the prespecified subgroup of patients with a baseline 6MWD below the trial median of 333 meters (n = 119), at Week 12:

  • 6MWD: least-squares mean change was +23.7 meters on TNX-103 versus −2.6 meters on placebo; treatment difference of +26.3 meters (p = 0.0112).
  • KCCQ-TSS: change was +9.8 points on TNX-103 versus +4.1 points on placebo; a 5-point threshold is generally considered clinically meaningful.
  • RVSP: change of −4.4 mmHg on TNX-103 versus +0.5 mmHg on placebo; treatment difference −4.9 mmHg (p = 0.009). (post-hoc analysis)
  • NT-proBNP: geometric least-squares mean ratio of 0.53 from baseline on TNX-103 (p < 0.0001), corresponding to a 47% reduction compared to placebo. (post-hoc analysis)

The Company intends that the LEVEL-2 population be enriched on the basis of clear evidence provided by the LEVEL results, and in a manner consistent with longstanding FDA guidance for sponsors. Tenax will continue to focus on the global development of this product for patients with high unmet need.

About Levosimendan (TNX-101, TNX-102, TNX-103)

Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL-2, a Phase 3, double-blind, randomized, placebo-controlled clinical trial in patients with PH-HFpEF.

About Tenax Therapeutics

Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.

Caution Regarding Forward-Looking Statements

Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning our clinical data, our regulatory plans, our future trial designs, and our possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the results of such trials, and the design, timing, delays, costs, location, initiation, and enrollment of any future trials; any delays in regulatory review and approval of product candidates in development; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates;   risks related to our business strategy, including the prioritization and development of product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; our estimates regarding the potential market opportunity for our product candidates; cash usage and runway may not be within management’s expected ranges; the potential advantages of our product candidates; our competitive position; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including our executives and members of our Board of Directors; risks associated with our cash needs; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.

Contact:

Investor and Media:
Argot Partners
[email protected]



Posted on

Hyliion Holdings Corp. Sued for Securities Law Violations – Contact the DJS Law Group to Discuss Your Rights – HYLN

Hyliion Holdings Corp. Sued for Securities Law Violations – Contact the DJS Law Group to Discuss Your Rights – HYLN

LOS ANGELES–(BUSINESS WIRE)–The DJS Law Group reminds investors of a class action lawsuit against Hyliion Holdings Corp. (“Hyliion” or “the Company”) (NYSE American: HYLN) violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.

Shareholders who purchased shares of HYLN during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery.

CLASS PERIOD: May 12, 2026 to June 23, 2026

DEADLINE: October 27, 2026

CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. Hyliion announced a deal with an entity that seems to lack actual business activity to artificially inflate its share price, which executives traded on. Based on these facts, Hyliion’s public statements were false and materially misleading throughout the class period.

If you are a shareholder who suffered a loss, contact us to participate.

WHY DJS LAW GROUP? DJS Law Group’s primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results.

Join the case to recover your losses.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

David J. Schwartz
DJS Law Group
274 White Plains Road, Suite 1
Eastchester, NY 10709
Phone: 914-206-9742
Email: [email protected]

KEYWORDS: California New York United States North America

INDUSTRY KEYWORDS: Class Action Lawsuit Professional Services Legal

MEDIA:

Posted on

Takeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera

Takeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera

  • MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)
  • MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue
  • Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32

OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Takeda (TSE:4502/NYSE:TAK)announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260824773270/en/

MIMRYLO Logo

MIMRYLO Logo

MIMRYLO is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction to control hematocrit levels, which is the ratio of red blood cells to the total amount of blood in the body. Maintaining controlled hematocrit levels below 45% is the primary treatment goal in PV.1

“For patients living with PV, uncontrolled hematocrit can have serious consequences, including an elevated risk of life-threatening thrombotic events,” said Andrew T. Kuykendall, M.D., VERIFY lead investigator and Associate Member in the Department of Hematology at Moffitt Cancer Center. “Current treatments, such as phlebotomy, leave a significant gap for too many patients and can pose challenges to daily life and routines. The approval of MIMRYLO offers clinicians and patients a novel, first-in-class therapy that targets erythrocytosis, which drives excess red blood cell production in PV. The strength and consistency of the VERIFY data give me real confidence in MIMRYLO’s potential to advance how we treat PV in everyday practice and to maintain hematocrit control.”

Uncontrolled Hematocrit is a Challenge in the Treatment of PV

Affecting approximately 90,000 people in the U.S., PV is characterized by the overproduction of red blood cells (erythrocytosis), leading to elevated hematocrit which can increase blood viscosity, or thickness.2,3 This has the potential to result in life-threatening thrombotic events, including stroke, deep vein thrombosis and pulmonary embolism.4 Maintaining hematocrit levels consistently below 45% can prevent thrombotic events and alleviate burdensome symptoms, including severe fatigue, pruritus (itching), difficulty concentrating and night sweats.4 An estimated 78% of patients still experience uncontrolled hematocrit with current standard of care, including phlebotomy and cytoreductive therapies.5 Patients with PV experiencing uncontrolled hematocrit have a four times higher risk of cardiovascular death or major cardiovascular events.4

“People living with PV often experience complex and invisible symptoms, from extreme fatigue to the emotional strain of living with a chronic blood cancer,” said Kapila Viges, Chief Executive Officer, MPN Research Foundation. “At the same time, we know that every patient’s experience with PV is different, underscoring the need to continue to listen closely to the community to understand what matters most. There remains a need for treatments that better address these daily challenges. This meaningful approval reflects important progress and brings forward a new treatment option in a disease where patients have long needed innovation and more choices. We are encouraged by MIMRYLO’s potential to help patients meet their treatment goals.”

MIMRYLO is a First-In-Class Treatment Option for Adults with PV

The approval was supported by data from the global randomized Phase 3 VERIFY study (NCT05210790) that included 293 patients with PV, showing that MIMRYLO met all efficacy endpoints and demonstrated a favorable safety profile. In the study, patients receiving MIMRYLO plus current standard of care demonstrated a higher response rate compared to placebo plus current standard of care. This included hematocrit control, a reduction in the need for phlebotomy and improvement in fatigue as measured by PROMIS Fatigue Short Form 8a.

MIMRYLO was generally well-tolerated through 52 weeks of treatment in the VERIFY trial. The most common treatment-emergent adverse events in MIMRYLO-treated patients were injection site reactions and anemia. Learn more about the Phase 3 data results here.

“The approval of MIMRYLO underscores the strength of Takeda’s late-stage pipeline and our focus on developing genuinely differentiated therapies for patients who are urgently waiting for new options,” said Julie Kim, President and Chief Executive Officer, Takeda. “We are at an important inflection point as we prepare to deliver three new medicines, which have the potential to drive our future growth and are a reflection of our commitment to advancing innovation that doesn’t just add to the treatment landscape, but reshapes it. We are grateful to the patients, care partners, advocates and investigators who helped make this approval possible.”

The open-label extension of the VERIFY trial is ongoing and Takeda will share further findings at upcoming medical conferences. Takeda is working with regulators outside of the U.S. to potentially bring MIMRYLO to more patients worldwide.

This approval does not result in any changes to Takeda’s consolidated financial forecast for the fiscal year ending March 31, 2027 (FY2026).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • New or Worsening Thrombocytosis: MIMRYLO may increase platelet counts in patients with PV. Platelet counts generally plateaued on treatment by Week 8. After initiating MIMRYLO and during dose modifications, monitor CBC every 2 to 4 weeks or as clinically indicated. Platelet elevations associated with MIMRYLO may require cytoreductive therapy initiation, modification, or MIMRYLO dose modifications or discontinuation.
  • Injection-Site Reactions: Injection site reactions (including Grade 3 reactions) have been reported in patients treated with MIMRYLO. The most common injection site reactions reported were erythema, pruritus, pain, and swelling. Use ice, topical corticosteroid creams, antihistamines or analgesics, as needed, to treat injection site pain and swelling.
  • Embryo-Fetal Toxicity: Based on findings from animal reproduction studies, MIMRYLO may cause fetal harm when administered to a pregnant woman. Advise patients to stop taking MIMRYLO if they become pregnant.

ADVERSE REACTIONS

The most common (>15%) adverse reactions were injection site reactions (56%) and anemia (16%).

USE IN SPECIFIC POPULATIONS

  • Lactation: Because of the potential for serious adverse reactions in the breastfed child, including impaired iron absorption, advise patients not to breastfeed during treatment with MIMRYLO and for 30 days after the final treatment.
  • Females and Males of Reproductive Potential
    • Pregnancy Testing: Prior to initiating MIMRYLO, pregnancy testing is recommended for females of reproductive potential.
    • Contraception: Advise female patients of reproductive potential to use effective contraception during treatment with MIMRYLO and for at least 30 days after the final dose of MIMRYLO.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-662-8532 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see MIMRYLO (rusfertide) full Prescribing Information.

About MIMRYLO™

MIMRYLO™ is a first-in-class subcutaneous treatment that mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and erythrocytosis. By targeting the underlying mechanism of iron dysregulation in polycythemia vera, MIMRYLO aims to reduce excess red blood cell production and help patients maintain hematocrit control. MIMRYLO is administered once weekly via subcutaneous injection and has been generally well-tolerated in clinical trials to date. Protagonist discovered MIMRYLO and led its development through Phase 3. Takeda now has exclusive global development and commercialization rights for MIMRYLO.

About VERIFY

The Phase 3 VERIFY study (NCT05210790) is an ongoing, three-part, global, randomized, placebo-controlled study evaluating MIMRYLO in 293 patients with polycythemia vera over a 156-week period, with treatment extension for participants who are continuing to derive benefit from MIMRYLO beyond the 156-week treatment period. The study is evaluating the efficacy and safety of once-weekly, subcutaneously self-administered MIMRYLO in patients with uncontrolled hematocrit who are phlebotomy-dependent despite current standard of care treatment, which could include phlebotomy, hydroxyurea, interferon and/or ruxolitinib.

The primary endpoint of the study was the proportion of patients achieving a response during Weeks 20-32, which was defined as the absence of “phlebotomy eligibility.” To meet phlebotomy eligibility, patients in the study were required to have: confirmed hematocrit ≥45% that was ≥3% higher than their baseline hematocrit value, or hematocrit ≥48%. Key secondary endpoints evaluated at Week 32 included mean number of phlebotomies, proportion of patients maintaining hematocrit <45%, mean change in fatigue score as measured by PROMIS Fatigue Short Form 8a and total symptom burden as measured by Myelofibrosis Symptom Assessment Form (MFSAF) Version 4.0.

All patients have completed their participation in the randomized, placebo-controlled portion of the study evaluating the efficacy and safety of MIMRYLO plus current standard of care versus placebo plus current standard of care and are now in the open-label portions of the study.

About Polycythemia Vera (PV)

Polycythemia vera (PV) is a chronic blood cancer characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, and can result in life threatening thrombotic events such as stroke, deep vein thrombosis and pulmonary embolism. Hematocrit is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of less than 45% is the primary treatment goal in PV to prevent thrombotic events and alleviate burdensome symptoms, including severe fatigue, difficulty in concentrating, night sweats and pruritus.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Takeda Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Takeda Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at https://www.sec.gov/. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Takeda Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

*Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera

References

  1. Barbui T, et al. Philadelphia chromosome-negative classical myeloproliferative neoplasms: revised management recommendations from European LeukemiaNet. Leukemia 2018; 32(5), 1057-1069.

  2. Vachhani PJ. Estimated prevalence of polycythemia vera in the United States (2025-2030): SEER analysis with modeled reporting delay. J Clin Oncol.2026;44(suppl 16):e18589.

  3. Lu X, Chang R. Polycythemia Vera. [Updated 2023 Apr 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557660/
  4. Marchioli R, et al. Cardiovascular events and intensity of treatment in polycythemia vera. N Engl J Med 2013;368:22-33.

  5. VVerstovsek S, et al. Real-world treatments and thrombotic events in polycythemia vera patients in the USA. Ann Hematol 2023;102:571-581.

 

Investor Relations

Christopher O’Reilly

[email protected]

Japanese Media

Tsuyoshi Tada

[email protected]

U.S. and International Media

Lauren Sherman

[email protected]

KEYWORDS: Massachusetts United States Japan North America Asia Pacific

INDUSTRY KEYWORDS: Oncology Health FDA Clinical Trials Pharmaceutical Cardiology Biotechnology

MEDIA:

Logo
Logo
Photo
Photo
MIMRYLO Logo
Photo
Photo
MIMRYLO Packaging
Posted on

20/20 BioLabs Reschedules Investor Webinar to 2:00 p.m. Eastern Time on September 2, 2026 to Discuss OneTest™ Revenue and Expanding Commercial Opportunity

CEO Jonathan Cohen to Detail the Company’s Strongest Quarterly Performance Since Commercial Launch of Multi-Cancer Early Detection Testing, Key Takeaways from the Next Generation Dx Summit, and Path to Broader Commercial Adoption

Webinar to Be Held Wednesday, September 2, 2026 at 2:00 p.m. Eastern Time; Registration Is Now Open

GAITHERSBURG, Md., Aug. 28, 2026 (GLOBE NEWSWIRE) — 20/20 BioLabs, Inc. (Nasdaq: AIDX) (“20/20 BioLabs” or the “Company”), an early market entrant in AI-powered, laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases, today announced that its previously announced investor webinar on Wednesday, September 2, 2026 has been rescheduled to 2:00 p.m. Eastern time.

The webinar was previously scheduled to begin at 12:00 p.m. Eastern time on the same date. Jonathan Cohen, President and Chief Executive Officer of 20/20 BioLabs, will discuss the Company’s second quarter 2026 results, which included the highest OneTest™ revenue in the Company’s history, as well as his presentation at the 18th Annual Next Generation Dx Summit and how the science he presented there connects to the Company’s commercial, regulatory, and reimbursement strategy.

To access the webinar, please use the following information:

Date: Wednesday, September 2, 2026
Time: 2:00 p.m. Eastern time (11:00 a.m. Pacific time)
Webcast: Please click here to register.


During the webinar, management expects to address the following topics:

  • A review of the Company’s second quarter 2026 results, including record OneTest™ revenue of $0.7 million, an increase of 47.1% year-over-year. Management believes this was the strongest quarterly performance since commercial launch of multi-cancer early detection (“MCED”) testing;
  • The operating leverage the Company is beginning to demonstrate in its laboratory model, with gross profit increasing 86.6% and gross margin expanding to 41.7% from 30.5%, and how management expects incremental testing volume to be absorbed across a largely fixed laboratory cost base;
  • Key takeaways from Mr. Cohen’s presentation at the 18th Annual Next Generation Dx Summit in Washington, D.C., “Aligning MCED with MAHA: Combining Protein Tumor and Inflammatory Biomarkers for Both Early Detection and Prevention of Cancers through Anti-Inflammatory Lifestyle Enhancements,” and what he heard from the clinical, regulatory, and commercial leaders in attendance;
  • The evolution of the OneTest™ platform, from a first-generation MCED blood test built on protein tumor biomarkers, to a second generation that adds inflammatory biomarkers, to a planned third-generation test designed for quarterly monitoring of both biomarker classes using at-home, upper-arm capillary blood collection devices;
  • Continued momentum in state-funded firefighter cancer screening, including Vermont’s 12-month statewide initiative to screen up to 4,500 firefighters and the $520,000 awarded to Maryland fire departments, the revenue the Company expects these programs to generate through the end of 2026, and its expected path to having tested more than 35,000 firefighters by year-end;
  • How that growing body of real-world evidence is intended to support the Company’s regulatory and reimbursement strategy, including the statutory Medicare pathway for FDA-authorized MCED blood tests beginning in 2028, and the Company’s serial biomarker tracking methodology, which follows biomarker trajectories over time rather than relying on single-point testing;
  • Commercial expansion across occupational health, military, intelligence community, physician practice, and retail channels, including the 29 new accounts added during the second quarter; and
  • A live question-and-answer session with management.

“The second quarter was the strongest quarterly performance since commercial launch for multi-cancer early detection testing, and the audience I addressed at the Next Generation Dx Summit is exactly the group that shapes how quickly tests like ours reach patients,” said Jonathan Cohen, President and Chief Executive Officer of 20/20 BioLabs. “On September 2, I want to connect those two threads for investors: the science of pairing protein tumor markers with inflammatory markers for both detection and prevention, and the commercial and reimbursement pathway that record OneTest™ volume is helping us build.”

The September 2 webinar is part of the Company’s monthly investor webinar series, held on the first Wednesday of each month, generally at 12:00 p.m. Eastern time. Investors and other interested parties are encouraged to submit questions in advance to [email protected]. A replay will be made available through the Company’s investor relations website following the event.

As part of its commitment to expanding access to early cancer detection, 20/20 BioLabs will provide webinar attendees with a promotional discount code for OneTest™ at the conclusion of the event. The offer will be available to all attendees, regardless of shareholder status.

Additional detail on the Company’s second quarter 2026 results is available in the earnings release issued on August 17, 2026, and in the Company’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission. The webinar is not expected to include the disclosure of any material non-public information.

About 20/20 BioLabs

20/20 BioLabs, Inc. (Nasdaq: AIDX) develops and commercializes AI-powered, laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases. The Company offers two families of lab tests under the OneTest brand. OneTest™ for Cancer is a multi-cancer early detection blood test and OneTest™ for Longevity measures inflammatory biomarkers and is commercially available. OneTest’s tests are designed to be affordable and accessible and can be conveniently utilized at home using new, upper-arm capillary collection devices as an alternative to traditional venipuncture. Tests are run in the Company’s College of American Pathologists (CAP) accredited, Clinical Laboratory Improvement Amendments (CLIA) licensed laboratory in Gaithersburg, Maryland.

For more information visit https://2020biolabs.com.

Forward-Looking Statements

Certain statements in this release are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that it believes may affect its financial condition, results of operations, business strategy, regulatory strategy, reimbursement strategy, growth strategy, and financial needs. Forward-looking statements can be identified by words such as “may,” “could,” “will,” “should,” “would,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “project,” “continue,” or the negative of these terms or other comparable expressions. A number of factors could cause actual results to differ materially from those contained in these forward-looking statements, including, but not limited to, the risks described in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), which are available on the SEC’s website at www.sec.gov, including the Company’s most recent Annual Report on Form 10-K, as well as in its other reports filed or furnished from time to time with the SEC. The Company undertakes no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events, except as required by applicable law. Although the Company believes the expectations expressed in these forward-looking statements are reasonable, it cannot guarantee future results, and investors are cautioned that actual outcomes may differ materially from those anticipated.

Investor Relations

Chris Tyson
MZ Group
Direct: 949-491-8235
[email protected]



Posted on

CAR INVESTOR ALERT: Avis Budget Group, Inc. Investors with Substantial Losses Have Opportunity to Lead the Avis Class Action Lawsuit – RGRD Law

SAN DIEGO, Aug. 28, 2026 (GLOBE NEWSWIRE) — Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Avis Budget Group, Inc. (NASDAQ: CAR) securities (including those who bought Avis common stock to cover a short position) between February 20, 2026 and April 21, 2026, inclusive (the “Class Period”), have until September 29, 2026 to seek appointment as lead plaintiff of the Avis class action lawsuit. Captioned Hakimian v. Pentwater Capital Management LP, No. 26-cv-02275 (M.D. Fla.), the Avis class action lawsuit charges Pentwater Capital Management LP and its Chief Executive Officer with violations of the Securities Exchange Act of 1934.

If you suffered substantial losses and wish to serve as lead plaintiff of the

Avis

class action lawsuit, please provide your information here:


https://www.rgrdlaw.com/cases-avis-budget-group-class-action-lawsuit-car.html

You can also contact attorneys

Ken Dolitsky

or

Michael Albert

of Robbins Geller by calling 800/851-7783 or via e-mail at

[email protected]

.

CASE ALLEGATIONS: Avis provides car and truck rentals, car sharing, and ancillary products and services to business and consumers through its Avis, Budget, and Zipcar brands.

The Avis class action lawsuit alleges that Pentwater Capital Management LP and its CEO Matthew Halbower steadily accumulated a massive equity stake in Avis over a period of months, notwithstanding Avis’s weak underlying business fundamentals, while driving up its stock price by buying heavily in the midst of a short-squeeze dynamic. Then, only after Avis’s stock price peaked at $847.70 per share on April 21, 2026, Pentwater sold 4.3 million shares of Avis stock into the market between April 22 and 23, for $1.75 billion in proceeds and causing Avis’s share price to plummet, the complaint alleges.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Avis securities during the Class Period to seek appointment as lead plaintiff in the Avis class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Avis class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Avis class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Avis class action lawsuit.

ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities fraud and shareholder rights litigation. Our Firm ranked #1 on the most recent ISS Securities Class Action Services Top 50 Report, recovering more than $916 million for investors in 2025. This marks our fourth #1 ranking in the past five years. And in those five years alone, Robbins Geller recovered $8.4 billion for investors – $3.4 billion more than any other law firm. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world, and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information:


https://www.rgrdlaw.com/services-litigation-securities-fraud.html

Past results do not guarantee future outcomes. 
Services may be performed by attorneys in any of our offices. 

Contact:
        Robbins Geller Rudman & Dowd LLP
        Ken Dolitsky
        Michael Albert
        655 W. Broadway, Suite 1900, San Diego, CA 92101
        800/851-7783
        [email protected]



Posted on

Trinity Biotech Provides Diagnostics Business, Transformation And Corporate Update

– Continued execution of transformation strategy drives commercial, manufacturing and pipeline progress

– PrePsia™ patent portfolio expands to nine granted U.S. and European patents

– Company issues update on Nasdaq listing

DUBLIN, Aug. 28, 2026 (GLOBE NEWSWIRE) — Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, today provided an update on key developments across its diagnostics business, highlighting continued commercial progress, operational transformation and diagnostic pipeline advancement.

Strengthening Commercial Leadership in Europe

Trinity Biotech is pleased to announce that Jordi Romero has joined the Company as Head of Commercial Operations – Europe. Mr. Romero brings extensive experience in diagnostic sales, marketing and commercial leadership, including significant expertise within the haemoglobin diagnostics market. He joins Trinity at an important stage in the Company’s transformation as it seeks to accelerate profitable growth across its diagnostics franchise in Europe and other international markets. 

Mr. Romero’s appointment forms part of Trinity’s broader strategy to strengthen its commercial organisation, deepen customer engagement and enhance execution across key international markets.

Continued Rollout of Upgraded HbA1c Column Technology

The Company also announced continued progress in the commercial rollout of its next-generation high-capacity HbA1c column system for the FDA-cleared Premier Hb9210™ analyser. Trinity has now successfully completed rollout of the upgraded column system in three of its largest international markets and is receiving positive customer feedback regarding performance and overall user experience.

Designed for Trinity Biotech’s Premier Hb9210™ analyser, the Company’s dedicated laboratory HbA1c solution, the upgraded column system delivers up to four times the testing capacity compared to the existing column system and minimizes instrument downtime through improved stability and reduced calibration requirements. These operational gains create a more efficient workflow for clinical laboratories and support broader adoption of the platform.

The Company expects continued deployment across additional markets over the coming quarters.

Operational Transformation Driving Margin and Working Capital Benefits

Trinity continues to execute its comprehensive operational transformation programme, including the transition of significant portions of the manufacturing process for its World Health Organization-approved rapid HIV test portfolio to an outsourced manufacturing structure.

The Company has successfully completed manufacture of the previously announced approximately 9 million TrinScreen HIV tests under this new operating model and has now also commenced manufacture of Uni-Gold™ HIV utilising its outsourced manufacturing structure.

The Company remains focused on scaling Uni-Gold™ HIV production and has currently a strong order book for the product.

Once fully scaled, the Company expects the outsourced manufacturing model to deliver meaningful improvements in gross margin performance, manufacturing efficiency and working capital utilisation.

As previously indicated, the transition and scale-up process may result in quarter-to-quarter variability in Uni-Gold™ HIV revenues during the ramp-up period as manufacturing output continues to increase and supply chain inventories are optimised.

Continued Advancement of the Diagnostics Pipeline

Trinity also continues to advance its pipeline of innovative diagnostic products.

Most recently, the Company received a European patent covering the use of blood pressure-related metrics in its PrePsia™ early preeclampsia prediction platform. This brings the total number of PrePsia™ related granted patents across Europe and the United States to nine and further strengthens the intellectual property protection around the Company’s maternal health programme.

PrePsia™ is being developed as an early screening test designed to identify pregnancies at increased risk of preterm preeclampsia, one of the leading causes of maternal and foetal morbidity worldwide. The Company believes the continued expansion of the intellectual property portfolio supporting PrePsia™, and its underpinning technologies, strengthens the foundation for future commercialisation opportunities in women’s health diagnostics. 

The Company intends to launch the PrePsia™ test through its existing New York State Department of Health approved reference laboratory.

Transformation Continues to Gain Momentum

The Company believes these achievements demonstrate continued execution against its strategy to transform Trinity Biotech into a more efficient, commercially focused and innovation-driven diagnostics business.

Key areas of progress include:

  • Strengthening commercial leadership and market execution.
  • Enhancing the competitiveness of the Premier Hb9210 platform.
  • Improving manufacturing efficiency through strategic outsourcing initiatives.
  • Expanding intellectual property protection around high-value diagnostic pipeline assets.
  • Positioning the business for sustainable margin expansion and profitable growth.

Nasdaq Notice 

As previously reported in a Current Report on Form 6-K filed February  20, 2026, on February  19, 2026, the Company received a deficiency letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, for the preceding 30 consecutive business days, the market value of publicly held shares (“MVPHS”) remained below the minimum $15 million for continued inclusion on The Nasdaq Global Select Market pursuant to Nasdaq Listing Rule 5450(b)(3)(c) (the “MVPHS Requirement”). The Company was provided an extension of 180 calendar days, or until August 18, 2026, (the “Compliance Period”) to regain compliance with the MVPHS Requirement. 

On August 28, 2026, the Company received a staff determination letter (the “Determination Letter”) from the Staff notifying the Company that it had not regained compliance with the MVPHS Requirement by August 18, 2026. Accordingly, and as described in the Determination Letter, unless the Company timely requests a hearing before a Hearings Panel (the “Panel”), the Company’s securities would be subject to suspension/delisting. Accordingly, the Company intends to timely request a hearing before the Panel.

The Company has a number of initiatives and strategic transactions at advanced stages, which, if completed, would be expected to increase the Company’s MVPHS above the $15 million minimum. The Company intends to continue to progress these transactions and as such management remains confident that the actions currently underway will enable the Company to reach a MVPHS of over $15 million.

The hearing request will automatically stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. In that regard, pursuant to the Nasdaq Listing Rules, the Panel has the authority to grant an extension not to exceed February 24, 2027.

Notwithstanding the foregoing, there can be no assurance that the Panel will grant the Company an additional extension period or that the Company will ultimately regain compliance with all applicable requirements for continued listing on The Nasdaq Global Select Market.  

Forward-Looking Statements

This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterized by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on the Waveform transaction and our recent acquisitions, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, our ability to successfully develop and commercialize data center cooling & thermal management solutions for AI and high-performance computing, the impact of the spread of COVID-19 and its variants, the possible pause and/or disruption in U.S. Government funding for HIV tests produced by Trinity Biotech, potential excess inventory levels and inventory imbalances at the Company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties, and risks related to the condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2025 and Trinity Biotech’s other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.

About Trinity Biotech

Trinity Biotech plc (NASDAQ: TRIB) is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors. The Company develops, acquires, manufactures, and markets diagnostic systems for the point-of-care and clinical laboratory segments of the diagnostic market and has recently entered the wearable biosensor industry through the acquisition of biosensor assets from Waveform Technologies Inc. Through its Trinovium subsidiary, Trinity Biotech is extending its fluid manufacturing and analytical capabilities into advanced liquid cooling solutions for AI data center infrastructure. Trinity Biotech sells directly in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please visit www.trinitybiotech.com.

Contact: Trinity Biotech plc  RedChip Companies Inc.
  Paul Murphy Dave Gentry, CEO
  (353)-1-2769800 (1)-407-644-4256
    (1)-800-RED-CHIP (733-2447)
    [email protected]



Posted on

AiRWA receives expected notification of deficiency from Nasdaq related to delayed filing of annual report on Form 10-K

Smyrna, Delaware, Aug. 28, 2026 (GLOBE NEWSWIRE) — AiRWA Inc. (NASDAQ: YYAI) (the “Company”) today announced that it received an expected deficiency notification letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) on August 24, 2026 (the “Notice”). The Notice indicated that the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) (the “Listing Rule”) as a result of its failure to timely file its Annual Report on Form 10-K for the year ended April 30, 2026 (the “Form 10-K”), as described more fully in the Company’s Form 12b-25 Notification of Late Filing (the “Form 12b-25”) filed with the Securities and Exchange Commission (the “SEC”) on July 30, 2026. The Listing Rule requires Nasdaq-listed companies to timely file all required periodic reports with the SEC.

The Notice has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Capital Market.

In accordance with Nasdaq’s listing rules, the Company has 60 calendar days after the Notice, or until October 23, 2026, to submit a plan to regain compliance with the Listing Rule. Pursuant to the Notice, following receipt of such plan, Nasdaq may grant an extension of up to 180 calendar days from the Form 10-K’s due date, or until January 25, 2027, for the Company to regain compliance. The Company expects and intends to file the Form 10-K before the October 23, 2026, deadline for submission of the plan.

As previously disclosed, the filing of the Form 10-K was delayed due to the matters described in the Form 12b-25. Following a significant acquisition, it has proved more time-consuming than anticipated to consolidate the financial results of the acquired business with our own.

The Company continues to work diligently to complete its 2026 10-K and, once it is filed with the SEC, the Company anticipates regaining and maintaining compliance with its SEC reporting obligations and Nasdaq listing requirements.

About YYAI

AiRWA Inc. (Nasdaq: YYAI) is an AI-specialist company providing end-to-end, full-cycle “data-to-AI” services designed to empower enterprises to transition seamlessly from raw data to intelligent applications through a closed-loop system of data generation, model refinement, and operational feedback. Through its subsidiary, Yuanyu Enterprise Management Co., Limited, AiRWA also owns advanced patents and proprietary technology that have been licensed to partners worldwide to enable them to develop localized digital matchmaking and other technology solutions. The company has been aiming to drive innovation in digital finance through AiRWA Exchange, which was conceived to focus on the tokenization of real-world assets (RWA), particularly tokenized U.S. stocks. And following a recent acquisition, the company operates an international trading business that is expanding from Asia to Europe, North America, and elsewhere.

YYAI Contact Information

Email: [email protected]
Website: www.yuanyuenterprise.com

Forward-Looking Statements

This press release contains forward-looking statements. Statements that are not historical facts, including statements about beliefs or expectations, are forward-looking statements. These may be identified by the use of words such as “expect,” “anticipate,” “believe,” “may,” “will,” “should,” “plan,” “project,” “intend,” “estimate,” and similar expressions. There can be no assurance that the benefits contemplated by the contract described herein will be achieved. Statements such as these are based on current plans, estimates, and expectations, and involve inherent risks and uncertainties. Factors that could cause actual results to differ include, but are not limited to:

  • product development risks;
  • regulatory approvals;
  • market acceptance;
  • competitive dynamics;
  • the ability to apply the new AI models to the specific aspects of the business as contemplated herein;
  • the effects of prior acquisitions and divestitures on current and future business operations;
  • strategic and operational uncertainties;
  • risks associated with potential litigation, financing transactions, or acquisitions;
  • macroeconomic, competitive, legal, regulatory, tax, and geopolitical factors; and
  • other risks detailed in the Company’s filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended April 30, 2025.

Forward-looking statements speak only as of the date they are made. Neither the Company nor any other person undertakes to update any forward-looking statements, except as required by law.