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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.

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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

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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/

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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

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Japanese Media

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U.S. and International Media

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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.



Posted on

NIKE, Inc. Announces First Quarter Fiscal 2027 Earnings and Conference Call

NIKE, Inc. Announces First Quarter Fiscal 2027 Earnings and Conference Call

BEAVERTON, Ore.–(BUSINESS WIRE)–NIKE, Inc. (NYSE: NKE) plans to release its first quarter fiscal 2027 financial results on Thursday, October 1, 2026, at approximately 1:15 p.m. PT, following the close of regular stock market trading hours. Following the news release, NIKE, Inc. management will host a conference call beginning at 2:00 p.m. PT to review results.

The conference call will be broadcast live over the Internet and can be accessed at https://investors.nike.com/. For those unable to listen to the live broadcast, an archived version will be available at the same location through 9:00 p.m. PT, October 29, 2026.

About NIKE, Inc.

NIKE, Inc., headquartered in Beaverton, Oregon, is the world’s leading designer, marketer and distributor of authentic athletic footwear, apparel, equipment and accessories for a wide variety of sports and fitness activities. Converse, a wholly-owned NIKE, Inc. subsidiary brand, designs, markets and distributes athletic lifestyle footwear, apparel and accessories. For more information, NIKE, Inc.’s earnings releases and other financial information are available on the Internet at https://investors.nike.com/. Individuals can also visit https://about.nike.com/ and follow NIKE on LinkedIn, Instagram and YouTube.

Investor Contact:
Paul Trussell
[email protected]

Media Contact:
Sandra Carreon-John
[email protected]

KEYWORDS: Oregon United States North America

INDUSTRY KEYWORDS: Sports Fashion Retail Footwear General Sports

MEDIA:

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Posted on

Novanta to Present at Baird Global Healthcare Conference on Tuesday, September 15, 2026

Novanta to Present at Baird Global Healthcare Conference on Tuesday, September 15, 2026

BOSTON–(BUSINESS WIRE)–
Novanta Inc. (Nasdaq: NOVT) (the “Company”), a trusted technology partner to medical and advanced technology equipment manufacturers, announced today that Robert Buckley, Chief Financial Officer, and John Lesica, Chief Operating Officer of Medical Solutions, are scheduled to present at the Baird Global HealthcareConference on Tuesday, September 15, 2026, in New York, NY.

About Novanta

Novanta is a leading global supplier of core technology solutions that give medical and advanced industrial original equipment manufacturers a competitive advantage. We combine deep proprietary technology expertise and competencies in precision medicine and manufacturing, medical solutions, and robotics and automation with a proven ability to solve complex technical challenges. This enables Novanta to engineer core components and sub-systems that deliver extreme precision and performance, tailored to our customers’ demanding applications. The driving force behind our growth is the team of innovative professionals who share a commitment to innovation and customer success. Novanta’s common shares are quoted on Nasdaq under the ticker symbol “NOVT.”

More information about Novanta is available on the Company’s website at www.novanta.com. For additional information, please contact Novanta Inc. Investor Relations at (781) 266-5137 or [email protected].

Novanta Inc.

Investor Relations Contact:

(781) 266-5137

[email protected]

KEYWORDS: New York Massachusetts United States North America Canada

INDUSTRY KEYWORDS: Health Health Technology

MEDIA:

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Posted on

B2Gold Reports Fatality at the Masbate Gold Project

VANCOUVER, British Columbia, Aug. 28, 2026 (GLOBE NEWSWIRE) — B2Gold Corp. (TSX: BTO, NYSE AMERICAN: BTG, NSX: B2G) (“B2Gold” or the “Company”) regrets to report that a fatality occurred at the Masbate Gold Project in the Philippines on Friday, August 28, 2026. The employee was performing scheduled maintenance at the Water Treatment Plant when a pipe burst, resulting in a fatal injury.

Mike Cinnamond, President and CEO of B2Gold, said, “We are all deeply saddened by this tragic incident. Nothing is more important than the safety and well-being of our people, and our immediate focus is supporting the individual’s family and colleagues while fully investigating the circumstances surrounding the event. Our thoughts are with those who have been affected during this difficult time.”

The area of the incident has been secured and related work has been stopped while the investigation is completed. Mining and processing activities continue uninterrupted. The Company will provide additional information when appropriate.

About B2Gold Corp.

B2Gold is a responsible international gold producer headquartered in Vancouver, Canada. Founded in 2007, today, B2Gold has operating gold mines in Canada, Mali, Namibia and the Philippines, and numerous development and exploration projects in various countries.

ON BEHALF OF B2GOLD CORP.

“Mike Cinnamond”

President & Chief Executive Officer

[Source: B2Gold Corp.]



For more information on B2Gold, please visit the Company’s website at www.b2gold.com or contact:

Rebecca Henare
VP, Investor Relations & Corporate Development
+1 604-681-8371
[email protected]

Cherry DeGeer
Director, Corporate Communications
+1 604-681-8371
[email protected]