Market Newsdesk

PHILADELPHIA, Oct. 10, 2026 (GLOBE NEWSWIRE) —

Aardvark Therapeutics, Inc. (NASDAQ: AARD)

:

Grabar Law Office is investigating claims on behalf of Aardvark Therapeutics, Inc. (NASDAQ: AARD) shareholders who purchased shares on or shortly after the Company’s February 13, 2025, initial public offering (IPO) and have continued to hold their shares.

What is This Investigation About? The investigation follows the filing of a securities class action against Aardvark and certain of its officers and directors alleging violations of the federal securities laws in connection with statements concerning the safety and prospects of the Company’s lead drug candidate, ARD-101.

If you purchased
Aardvark Therapeutics, Inc. (NASDAQ: AARD)
shares on or shortly after the Company’s February 13, 2025 IPO
,
and still hold shares today,
you can seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to you whatsoever through a shareholder governance action. You are encouraged to visit

https://grabarlaw.com/the-latest/aardvark-shareholder-investigation/

,
contact Joshua Grabar at

[email protected]

,
or call 267-507-6085 to learn more.

What is Alleged? According to the recently filed securities complaint, Aardvark Therapeutics, Inc. (NASDAQ: AARD) IPO offering documents represented that ARD-101 had been “well-tolerated” in earlier clinical trials, had limited systemic absorption, and had demonstrated no serious adverse events. The complaint alleges that the offering documents were materially false or misleading because they failed to disclose that ARD-101 was less safe than investors had been led to believe and that its clinical, regulatory, and commercial prospects were therefore overstated.

The complaint further alleges that similar representations concerning ARD-101’s safety continued after the IPO. For example, Company representatives subsequently described ARD-101 as having a “very, very clean” safety profile and represented that its limited systemic exposure reduced the likelihood of side effects.

Then, on February 27, 2026, Aardvark announced that it was voluntarily pausing enrollment and dosing in the Phase 3 HERO trial after identifying reversible cardiac observations during safety monitoring in a healthy-volunteer study. Following the announcement, Aardvark’s stock price allegedly declined approximately 56%, closing at $5.47 per share on March 2, 2026.

Then, on May 14, 2026, Aardvark announced that the FDA had placed a full clinical hold on the investigational new drug application for ARD-101, including the Phase 3 HERO trial and its open-label extension. According to the complaint, Aardvark’s stock declined another 32.1% the following day, closing at $4.57 per share.

What Can You Do Now?
If you purchased Aardvark shares at or shortly after the February 13, 2025 IPO, and continue to own those shares today,
you can seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to you whatsoever. Please visit

https://grabarlaw.com/the-latest/aardvark-shareholder-investigation/

,
contact Joshua Grabar at

[email protected]

,
or call 267-507-6085 to learn more.    #AARD $AARD #Aardvark

Coastal Financial Corporation (NASDAQ: CCB)
:

Grabar Law Office is investigating claims on behalf of shareholders of Coastal Financial Corporation (NASDAQ: CCB).

What is This Investigation About? This investigation concerns possible breaches of fiduciary duties and other alleged misconduct by certain officers and directors of the Company.

Current Coastal Financial Corporation (NASDAQ: CCB) shareholders who have held Coastal shares since prior to October 28, 2024, are encouraged visit

https://grabarlaw.com/the-latest/coastal-shareholder-investigation/

, contact Joshua Grabar at

[email protected]

, or call 267-507-6085.
You
can
seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to you whatsoever.

What is Alleged? A recently filed federal securities fraud class action alleges that Coastal Financial Corporation (NASDAQ: CCB), through certain of its current and former executives, made materially false and misleading statements concerning the growth and credit quality of Coastal’s CCBX business, the adequacy of the Company’s risk-management and credit-monitoring practices, and the credit protections provided by CCBX partner indemnification agreements.

Specifically, that complaint alleges that, while Coastal represented that CCBX growth was being pursued in a disciplined manner with an emphasis on credit quality and risk management, defendants failed to disclose that: 1) the credit quality of a substantial CCBX partner loan portfolio consisting of approximately $500 million in loans, or nearly 23% of all CCBX loans, had materially deteriorated; 2) the deterioration exposed Coastal to significant credit losses despite representations concerning the protections provided by CCBX partner indemnification agreements; and 3) Coastal’s risk-management and credit-monitoring practices were allegedly inadequate to identify, properly account for and mitigate the deterioration and resulting risks.

The underlying complaint further alleges that Coastal repeatedly emphasized its investment in risk management and its contractual protection from CCBX credit losses. For example, in April 2025 Coastal represented that it remained fully indemnified against fraud and 98.8% indemnified against credit risk with its CCBX partners, and the Company made a similar representation as of March 31, 2026. Then, on July 30, 2026, Coastal announced its second-quarter 2026 financial results and reported a surprise GAAP net loss of $42.1 million, driven primarily by a $68.8 million credit expense associated with a single CCBX partner relationship. According to the complaint, the $68.8 million expense consisted of: 1) a $46 million valuation adjustment to the related credit-enhancement asset; and 2) a $22.8 million provision for credit losses associated with the partner’s indemnification obligations.

It is further alleged that Coastal also disclosed that the affected portfolio consisted of approximately $500 million in underlying loans, together with the related reimbursement exposure. Following these disclosures, Coastal common stock fell $30.75 per share, or 43.5%, closing at $39.91 per share on July 30, 2026. According to the complaint, the decline erased approximately $470 million in market capitalization.

The complaint additionally alleges that Chief Executive Officer Eric M. Sprink sold approximately $12 million of Coastal common stock during the Class Period, while former CFO Joel Edwards sold approximately $3.8 million. It is alleged that those sales occurred before the deterioration of the CCBX partner portfolio and Coastal’s resulting exposure were disclosed to investors.

What Can You Do Now?
If you have owned Coastal Financial Corporation (NASDAQ: CCB) shares since prior to October 28, 2024, you
can
seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to you whatsoever. Please
visit

https://grabarlaw.com/the-latest/coastal-shareholder-investigation/

, contact Joshua Grabar at

[email protected]

, or call 267-507-6085 to learn more.
#CoastalFinancial #CCB $CCB

Duolingo, Inc. (NASDAQ: DUOL):

Current Duolingo, Inc. shareholders who have held Duolingo shares since prior to May 2, 2025, are encouraged to contact Grabar Law Office to learn more about the investigation.

What is The Investigation About? Grabar Law Office is investigating claims on behalf of long-term shareholders of Duolingo, Inc. (NASDAQ: DUOL) concerning whether certain officers and directors of the Company breached fiduciary duties owed to Duolingo and its shareholders.

If you currently own Duolingo, Inc. (NASDAQ: DUOL) shares and have held those shares since prior to May 2, 2025,
please
visit

https://grabarlaw.com/the-latest/duolingo-shareholder-investigation/

, contact us at

[email protected]

, or call 267-507-6085.
you
can
seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to you whatsoever.

Why? As alleged in a federal securities fraud class action complaint, Duolingo, Inc.’s (NASDAQ: DUOL) growth strategy increasingly emphasized monetization through advertising, subscription-tier upselling and the use of rapidly generated artificial-intelligence content. In this context it is alleged that the company, through certain corporate officers made materially false or misleading statements and/or failed to disclose that: 1) Duolingo was deliberately increasing user “friction” through higher advertising volume and subscription upsells; 2) the Company’s extensive A/B testing allegedly showed that such friction was negatively affecting daily active user, or DAU, growth; 3) rapidly generated AI content was allegedly degrading the quality of Duolingo’s product offerings and user experience; and 4) the Company’s monetization strategy and lower-quality AI-generated content were allegedly undermining the sustainability of Duolingo’s growth and financial performance.

The complaint further alleges that, in April 2025, Duolingo introduced a new feature known as Energy, which replaced its prior Hearts system. According to the complaint, the Energy system was designed in part to create additional friction for free users and encourage them to convert to paid subscriptions, while Duolingo publicly characterized the feature as rewarding and beneficial to user engagement.

The complaint also alleges that Duolingo increasingly relied upon AI-generated content while representing to investors that its use of AI was improving the product and accelerating content creation. According to the complaint, users instead began reporting translation and pronunciation errors, repetitive lessons and other quality concerns associated with certain AI-powered features.

What Can Long-Term Duolingo Shareholders Do Now?
If you currently own Duolingo, Inc. (NASDAQ: DUOL) shares and have held those shares since prior to May 2, 2025, you
can
seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to you whatsoever. If you
would like to learn more about this matter, you are encouraged to visit

https://grabarlaw.com/the-latest/duolingo-shareholder-investigation/

, contact us at

[email protected]

, or call 267-507-6085. #Duol $DUOL #Duolingo

Ensign Group, Inc. (NASDAQ: ENSG)

:

What is Happening? Grabar Law Office is investigating claims on behalf of shareholders of Ensign Group, Inc. (NASDAQ: ENSG). The investigation concerns whether the Company and certain of its officers breached their fiduciary duties.

If you purchased or otherwise acquired
Ensign Group, Inc. (NASDAQ: ENSG) securities
prior to February 10, 2022, and still hold shares today, you can seek corporate reforms, the return of funds back to the Company, and a court approved incentive award at no cost you whatsoever. Please visit https://grabarlaw.com/the-latest/ensign-shareholder-investigation/, contact Joshua H. Grabar at [email protected], or call 267-507-6085. Alternatively, if you purchased Ensign Group shares between February 10, 2022 and June 18, 2026, you could participate in the class action.

What is Alleged? According to a recently filed federal securities fraud class action lawsuit, it is alleged that Ensign Group, Inc. (NASDAQ: ENSG) through certain of its officers, made false and/or misleading statements and/or failed to disclose that: (i) Ensign Group’s business model depends on the systematic and widespread neglect of elderly people who live in its facilities, including those with needs for high levels of care; (ii) Ensign Group’s abuse and neglect includes not giving residents enough food, medical attention, or even basic toiletries as well as failing to respond to residents in clear distress, which has resulted in resident deaths; (iii) Ensign Group uses self-reporting measures as a way to cover up that it systematically neglects patients; (iv) Ensign Group defrauds Medicaid and Medicare by taking federal funds to help patients who need high levels of care, and then neglecting those same patients; (v) Ensign Group falsifies the number of hours that Certified Nursing Assistants spend with residents; (vi) Ensign Group engages in an illegal scheme to rent the licenses of Administrators who are not generally present at, nor actually managing, its facilities; and (vii) Ensign Group materially understated the reputational and litigation exposure that comes with a dangerous, abhorrent, and illegal business model.

The truth began to emerge when on June 8, 2026, Hunterbrook Media published a report entitled “Ensign: The Nursing Home Empire Built on Fatal Neglect,” which alleged, among other things, that “Ensign’s business model relies on delivering inadequate care to patients while gaming data on quality . . . .  Patients are dying.” 

Then, on June 11, 2026, Muddy Waters Research published a report entitled “Ensign: Deceiving the Government at Estimated ~20% of Facilities.” 

Finally, on June 18, 2026, Hunterbrook Media issued a follow up report entitled “New: Patients Hungry in Ensign Facilities.”  The article stated that Ensign Group caregivers and residents had reached out to Hunterbrook Media to add “new, firsthand evidence of resident hunger, payroll falsification, understaffing, and staff licensing issues.” 

What Can You Do Now?
If you purchased or otherwise acquired
Ensign Group, Inc. (NASDAQ: ENSG securities
prior to February 10, 2022, and still hold shares today, please https://grabarlaw.com/the-latest/ensign-shareholder-investigation/, contact Joshua H. Grabar at [email protected], or call 267-507-6085. You can seek corporate reforms, the return of funds back to the Company, and a court approved incentive award at no cost you whatsoever. Alternatively, if you purchased Ensign Group shares between February 10, 2022 and June 18, 2026, you could participate in the class action.

#Ensign #EnsignGroup #ENSG $ENSG

Attorney Advertising Disclaimer

Contact:
Joshua H. Grabar, Esq.
Grabar Law Office
One Liberty Place
1650 Market Street, Suite 3600
Philadelphia, PA 19103
Tel:  267-507-6085
Email: [email protected]

NEW YORK, Oct. 10, 2026 (GLOBE NEWSWIRE) — LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX), a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain disorders, today announced the presentation of four posters at the 39^th European College of Neuropsychopharmacology (ECNP) Congress, taking place in Munich, Germany from October 10-13, 2026. The posters highlight new preclinical data describing LB-102’s differentiated mechanism of action, the pivotal program of LB-102 in schizophrenia (NOVA-2 and NOVA-3), the ongoing late-stage development of LB-102 in bipolar depression (ILLUMINATE-1), and a previously reported analysis of LB-102’s impact on cognitive performance from the Phase 2 NOVA-1 trial in schizophrenia.

“Our continued progress in the late-stage development of LB-102 for schizophrenia and mood disorders is reflected in the breadth of our presentations at ECNP this year,” said Susan G. Kozauer, LB Pharmaceutical’s Chief Medical Officer. “We are encouraged by the new preclinical data that provide further insights into the emerging clinical and tolerability profile of LB-102. These data strengthen the scientific rationale for the development of LB-102 in mood disorders and highlight a potential mechanism for addressing symptoms such as anhedonia that are common across several neuropsychiatric disorders.”

Presentation Details and Summary

The following posters were presented on Saturday, October 10, 2026 at 12:00-1:25 pm CEST:

Title: LB-102 effect on dopamine D2 autoreceptors: Results from a preclinical study evaluating dopamine efflux in rat nucleus accumbens using microdialysis

Poster Number: PS01-1019

The poster highlights preclinical data demonstrating that LB-102 can modulate dopamine signaling through engagement of pre-synaptic D2 autoreceptors whose normal function is to constrain dopamine release in a key brain region implicated in schizophrenia, mood disorders and other neuropsychiatric disorders. By attenuating autoreceptor-mediated inhibition of dopamine release, LB-102 increased dopamine neurotransmission. These results support a potential mechanism through which LB-102 may address the hypodopaminergic state associated with anhedonia and diminished motivation in depression. These findings support the scientific rationale for LB-102’s potential for clinical activity in mood disorders and highlight its potential to address symptoms such as anhedonia that is common across neuropsychiatric disorders.

Title: Effects of LB-102 on cognitive performance in patients with schizophrenia: Post hoc analyses from the phase 2 randomised NOVA-1 trial.

Poster Number: PS01-1156.

This encore poster presentation highlights the dose-dependent, statistically significant improvements in cognitive performance observed in the Phase 2 NOVA-1 trial in schizophrenia as measured by the Global Cognition composite score as well as a post hoc analysis that was designed to assess whether the observed improvement in cognitive performance was a direct effect of LB-102 or an indirect consequence of the effect of LB-102 on total schizophrenia symptoms. Results of the analysis demonstrated that the cognitive benefit was primarily a direct effect of LB-102.

Title: Phase 3 clinical development program of LB-102 in schizophrenia: A double-blind placebo-controlled trial (NOVA-2) and an open-label extension study (NOVA-3)

Poster Number: PS01-1226

The poster describes the ongoing, pivotal Phase 3 trial (NOVA-2) and open label extension trial (NOVA-3) designed to evaluate the efficacy, safety and long-term effectiveness of LB-102 as a once-daily treatment for adults with schizophrenia.

The following e-Poster is presented as an e-poster through the conference platform:

Title: LB-102 in patients with bipolar I disorder experiencing a major depressive episode: Phase 2, double-blind, placebo-controlled trial design (ILLUMINATE-1)

Poster Number: EP01-1056

The poster features the design of the ongoing, potentially registrational Phase 2 ILLUMINATE-1 trial evaluating the efficacy and safety of once-daily LB-102 monotherapy in adults with bipolar depression, as well its effects on cognition, anhedonia, and the incidence of treatment-emergent mania.

LB Pharmaceuticals presentations are available on the Publication page on LB Pharmaceuticals website at https://lbpharma.us.

About LB Pharmaceuticals

LB Pharmaceuticals is a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain disorders. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of a broad range of neuropsychiatric diseases.

About LB-102

LB-102 is a novel, once-daily, orally administered investigational small molecule being developed for multiple neuropsychiatric disorders. It is a new chemical entity that has been structurally engineered with a modification to amisulpride, a widely used antipsychotic outside the United States, and has the potential to be the first benzamide antipsychotic in the United States for the treatment of neuropsychiatric disorders. LB-102 was developed with the aim of retaining amisulpride’s benefits while addressing its limitations. LB-102 is a potent and selective antagonist of D2, D3, and 5-HT7 receptors with few off-target effects and which may have broad therapeutic potential across psychosis and mood disorders. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. In this trial, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid onset of effect at week 1 and sustained benefit through the endpoint of the trial, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside effects on negative symptoms and cognitive performance. These data underscore LB-102’s potential to address multiple dimensions of neuropsychiatric illness. The pivotal Phase 3 NOVA-2 trial of LB-102 for acute schizophrenia and the Phase 2 ILLUMINATE-1 trial of LB-102 for bipolar 1 depression are ongoing, and a Phase 2 trial of LB-102 in adjunctive treatment of MDD is planned. The Company is also pursuing additional expansion opportunities for LB-102 including predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as other neuropsychiatric diseases.

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the unique mechanism of LB-102, the potential therapeutic benefits of LB-102, and the design, objectives, initiation, timing, progress and expected results of clinical trials of LB-102. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.

These and other risks are described more fully in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Media and Investor Contact:

Ellen Rose
[email protected]

HIGH POINT, N.C., Oct. 10, 2026 (GLOBE NEWSWIRE) — vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company advancing cadisegliatin, a novel oral investigational therapy for type 1 diabetes (T1D), today announced that Chief Medical Officer Thomas Strack, M.D., Ph.D., presented research spotlighting hypoglycemia-related burdens among adults with T1D using automated insulin delivery (AID) systems at the inaugural Breakthrough T1D Clinical & Research Congress (CRC 2026) in Philadelphia, PA. Cadisegliatin is a potential first-in-class, liver-selective glucokinase activator (GKA) being evaluated as an oral adjunctive therapy to insulin for the treatment of T1D.
        
“A Cumulative Population View of Hypoglycemia-Related Burdens in T1D Adults Using AID Systems,” a quantitative online research initiative commissioned by vTv Therapeutics and conducted by dQ&A Market Research, Inc., examined the prevalence of clinically meaningful hypoglycemia-related burdens among 674 adults with T1D of whom 429 were using AID systems. Among adult AID system users, 24% reported experiencing frequent Level 2 hypoglycemia, defined as daily, almost daily, or a few moderate hypoglycemic events (<54 mg/dL) in a typical week. 12% reported a Level 3 event in the past 12 months, and 17% reported impaired awareness of hypoglycemia, defined as never or rarely noticing or feeling the symptoms of hypoglycemia. Among those with A1C >7%, 49% strongly agreed that they often keep their blood glucose higher to avoid hypoglycemia or that they would target lower glucose levels if not for the risk of hypoglycemia.

Respondents were then segmented using a mutually exclusive framework across the above four hypoglycemia-related burden dimensions. After accounting for overlap across segments and weighting for A1C, approximately 54% of adults with T1D using an AID system were estimated to experience at least one of the four dimensions of hypoglycemia-related burden.

“These findings reinforce that, despite meaningful advances in insulin delivery technology, insulin has its limitations and hypoglycemia continues to shape daily glucose management for many people with type 1 diabetes,” said Paul Sekhri, Chairman, President, and Chief Executive Officer of vTv Therapeutics. “The fact that more than half of adults using AID systems still experience clinically meaningful hypoglycemia-related burdens underscores the need for additional treatment options that can work alongside insulin and existing technologies to help address this burden.”

“Our mission at dQ&A is to serve as the voice of people living with diabetes. These findings highlight the challenges that many people with T1D continue to experience with hypoglycemia, including those using technologies such as AID,” said Richard Wood, Chief Executive Officer of dQ&A Market Research, Inc. “We are excited by the prospect of new therapies that could complement existing technologies and further alleviate this burden to give people greater confidence and freedom in their everyday lives.”

About Cadisegliatin 
Cadisegliatin (TTP399) is a novel, oral small-molecule, glucokinase activator being investigated in the U.S. as a potential first-in-class adjunctive treatment for T1D. In nonclinical studies, cadisegliatin acted selectively on the liver and increased the activity of glucokinase independently of insulin. These studies support clinical investigation of whether cadisegliatin can improve glycemic control through hepatic glucose uptake and glycogen storage. Cadisegliatin has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).  

Cadisegliatin is under investigation, and its safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated.  

About vTv Therapeutics 
vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, a potential first-in-class oral glucokinase activator being investigated in a U.S. Phase 3 study for the treatment of T1D. vTv and its development partners are investigating multiple molecules across different indications for chronic diseases. Learn more at vtvtherapeutics.com or follow the company on LinkedIn.

About dQ&A Market Research, Inc.

Founded in 2009, dQ&A Market Research is a leading diabetes-focused research firm dedicated to understanding the real-world experiences of people living with diabetes and those who care for them. Through our proprietary panels of thousands of patients and caregivers across the United States, Canada, and Europe, we conduct ongoing surveys and in-depth qualitative and quantitative research that capture the evolving needs, preferences, and challenges of the diabetes community. Our team includes seasoned researchers, data scientists, and consultants, many with a personal connection to diabetes, focused on delivering impactful and unbiased insights to the diabetes industry, government organizations, and medical associations. For more information, please visit www.d-qa.com or email [email protected].

Forward-Looking Statements  
This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other variations or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, the anticipated effect of Phase 3 topline data on the Company, the benefits of cadisegliatin to people living with T1D, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments we may undertake. We qualify all our forward-looking statements by these cautionary statements. 

Investor Contact

John Fraunces
LifeSci Advisors, LLC
[email protected]

Media Contact

Caren Begun
TellMed Strategies
201-396-8551
[email protected] 

• 
  New analyses on Furoscix ReadyFlow PK/PD performance delivered via an autoinjector demonstrated comparable urine output to IV furosemide
  
• Consistent bioavailability, diuresis and natriuresis across injection sites support flexible administration in clinical practice
• Cross-study analysis demonstrates comparable diuretic and natriuretic responses between Furoscix ReadyFlow and Furoscix
  
  ^®
  
  (furosemide) On-body Infusor, supporting a seamless transition to ReadyFlow
• 
  Data presentations build on the July 2026 FDA approval and U.S. launch of Furoscix ReadyFlow, the first and only autoinjector delivering IV-equivalent diuretic therapy for heart failure- and CKD-related edema (fluid overload)

  
  

WESTLAKE VILLAGE, Calif., Oct. 09, 2026 (GLOBE NEWSWIRE) — MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today announced new clinical data related to Furoscix ReadyFlow (furosemide injection) that will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2026, taking place October 9-12, 2026, in Phoenix.

The presentations further characterize the pharmacokinetic (PK) and pharmacodynamic (PD) performance of Furoscix ReadyFlow, MannKind’s recently approved autoinjector designed to deliver an 80 mg/mL dose of furosemide in under 10 seconds. Together, the findings reinforce the therapy’s IV-equivalent exposure and diuretic effect while highlighting administration flexibility and the potential to support outpatient management of worsening congestion in patients with heart failure (HF) or chronic kidney disease (CKD).

“As healthcare providers seek ways to manage worsening congestion earlier and outside the hospital setting, these data add to the growing body of evidence supporting Furoscix ReadyFlow as an important treatment option for patients with heart failure or chronic kidney disease,” said Dr. Ajay Ahuja, Chief Medical Officer of MannKind Corporation. “The findings presented at the HFSA ASM reinforce the consistent pharmacologic performance of Furoscix ReadyFlow while demonstrating flexibility that may help clinicians incorporate this innovative therapy into patient care.”

Key


presentations

:

Pharmacokinetic and Pharmacodynamic Profiles of Subcutaneous Furosemide Administered as a 5-Hour Infusion and 10-Second Injection

This post-hoc analysis juxtaposed PK and PD characteristics of the concentrated formulation of the subcutaneous furosemide autoinjector, formerly referred to as SCP-111 and now marketed as Furoscix ReadyFlow, and the Furoscix On-body Infusor. Both subcutaneous formulations achieved bioequivalence to IV furosemide and produced comparable diuretic and natriuretic responses. Cross-study comparisons should be interpreted cautiously because the two studies were conducted in separate populations. The findings demonstrate that both delivery approaches provide IV-equivalent outpatient diuresis while also demonstrating the rapid administration characteristics of the autoinjector.

Subcutaneous Injection of Furosemide: Consistent Pharmacokinetic and Pharmacodynamic Profiles Across Thigh and Arm Injection Sites Versus Intravenous Administration When Administered Via an Autoinjector

This randomized crossover study evaluated subcutaneous furosemide delivered via autoinjector in the thigh and in the upper arm compared with intravenous (IV) administration of furosemide. Furoscix ReadyFlow met the pre-determined bioequivalence criteria for AUC compared to IV furosemide at both injection sites, with relative bioavailability of 91.3% in the thigh and 92.7% in the upper arm. Measures of urine output and urinary sodium excretion were similar across treatments, and the therapy was generally well tolerated. These findings support the use of these alternative injection sites while maintaining consistent therapeutic performance.

“Patients living with heart failure and chronic kidney disease often experience recurrent episodes of worsening fluid overload that can lead to emergency department visits and hospitalization,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “With the recent launch of Furoscix ReadyFlow, healthcare providers now have access to a new autoinjector-based treatment option designed to deliver IV-equivalent diuretic therapy in seconds. These data presented at HFSA reinforce our commitment to advancing innovative solutions that may help patients receive treatment earlier and outside traditional hospital settings.”

Building on the Recent


Approval


and Launch of Furoscix ReadyFlow

In July 2026, the U.S. Food and Drug Administration approved Furoscix ReadyFlow for the treatment of fluid overload associated with heart failure or chronic kidney disease in adults. Furoscix ReadyFlow is the first and only autoinjector delivering subcutaneous furosemide with IV-equivalent exposure and diuretic effect, providing a full 80 mg/mL dose in a single administration in under 10 seconds. The therapy was designed to support earlier intervention for worsening fluid overload and may help expand treatment opportunities across outpatient, post-discharge and home-based care settings.

Visit MannKind at HFSA ASM 2026

MannKind’s commercial and medical affairs teams will be available at booth 428 throughout HFSA 2026 to discuss Furoscix and how it may support healthcare professionals managing fluid overload in patients with heart failure or chronic kidney disease.

What is Furoscix
^®
(furosemide injection) for subcutaneous use?

Furoscix is a prescription medicine used to treat fluid buildup, which can cause congestion or swelling (also known as edema), in pediatric patients who weigh at least 95 lbs. (43 kg) and adult patients with chronic heart failure or chronic kidney disease.

Furoscix ReadyFlow is not intended for use in children less than 18 years old.

Furoscix should be replaced with oral diuretics as directed by a healthcare provider. Follow the instructions provided by your physician when taking Furoscix.

IMPORTANT SAFETY INFORMATION


Before taking Furoscix, read the Instructions for Use and tell your healthcare provider about all your medical conditions, including if you have liver problems, trouble urinating, are allergic to furosemide or any of the ingredients in Furoscix, or if you are allergic to medical adhesives.

What are the possible side effects of Furoscix?

Dehydration: Furoscix can cause you to lose excess water and electrolytes. Symptoms of excess water and electrolyte loss include dry mouth, increased thirst, muscle pains or cramps, decreased urine output or urine more yellow than normal, headache, dry skin, nausea or vomiting. Your healthcare provider may check your electrolytes while receiving Furoscix.

Low Blood Pressure: Furoscix may cause your blood pressure to decrease temporarily. You may feel lightheaded or dizzy, particularly when you stand up. Getting up slowly may help.

High Blood Sugar: If you have diabetes mellitus, Furoscix may increase blood glucose levels.

Loss of Hearing: Furoscix can cause ringing in your ears. Tell your healthcare provider if you have trouble hearing while taking Furoscix.

Incomplete Dosing: When using the Furoscix ReadyFlow, if the viewing window does not turn completely yellow, or if you lift the Furoscix ReadyFlow off your skin too early, you may not receive a full dose. This could cause the medicine to not work as well as it should. If this happens call your healthcare provider for more instructions. Do not use another Furoscix ReadyFlow unless instructed to do so by your healthcare provider.

Getting the Furoscix On-body Infusor wet or moving your body so that it falls off or does not stick to your skin during treatment may stop the delivery of medicine before you receive a full dose. This could cause the medicine to not work as well as it should. If this happens call your healthcare provider for more instructions. Do not use a new On-body Infusor unless instructed to do so by your healthcare provider.

Your skin may be more sensitive to sunlight while taking Furoscix.

The most common side effects with Furoscix are administration site and skin reactions such as bruising, redness, swelling and administration site pain.

Call your healthcare provider for medical advice about side effects. You may report side effects to MannKind at 1-877-323-8505 or to the FDA at 1-800-FDA-1088.

For more information about Furoscix, please see the full Prescribing Information (www.furoscix.com/prescribing-information.pdf) and Instructions for use (www.furoscix.com/instructions-for-use.pdf).

About MannKind

MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.

With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

Learn more at mannkindcorp.com.

Forward-Looking Statements

Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding opportunities to help patients receive treatment earlier and outside traditional hospital settings. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that MannKind’s products may only achieve a limited degree of commercial success, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

FUROSCIX, FUROSCIX READYFLOW and MANNKIND are trademarks of MannKind Corporation.

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/b0c920d1-d4c8-470b-99e4-bd3af4869709

https://www.globenewswire.com/NewsRoom/AttachmentNg/6b71d5d0-822b-4c5e-a56c-002256924f7d

MannKind Contacts:

Media Relations:
Christie Iacangelo
(818) 292-3500
[email protected]

Investor Relations:
Kate Miranda
(617) 921-5461
[email protected]

NEW YORK, Oct. 09, 2026 (GLOBE NEWSWIRE) — Gainey McKenna & Egleston announces that it has filed a securities class action lawsuit in the United States District Court for the Southern District of Florida on behalf of all persons or entities who purchased or otherwise acquired Millrose Properties, Inc. (“Millrose” or the “Company”) (NYSE: MRP) securities between February 7, 2025 and October 2, 2026, inclusive (the “Class Period”), which charges Millrose and certain of Millrose’s top executives with violations of the Securities Exchange Act of 1934.

The Complaint alleges that Defendants failed to disclose to investors that: (i) despite representations to the contrary, Millrose’s objectives were not limited to engaging in land purchases, horizontal development, and homesite option purchase arrangements for Lennar and potentially other homebuilders and developers; (ii) despite representations to the contrary, Millrose would in fact enter into lease agreements and would have tenants in its properties; (iii) Millrose would purchase $200 million worth of properties from Lennar; (iv) Millrose would lease the properties purchased from Lennar out at a loss; and (v) as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis. 
        
The Complaint further alleges that the truth emerged on October 2, 2026 when Hunterbrook Media (the “Hunterbrook Report”) issued a report revealing that, contrary to Millrose’s earlier representations, Millrose purchased $200 million worth of finished homes from Lennar, an entity that controls Millrose, with the intent of leasing those properties on the rental market. The Complaint continues to allege that on this news, Millrose’s share price fell by $2.10, or 8.5%, from a close of $24.61 on October 2, 2026 to a close of $22.51 on October 5, 2026.

Investors who purchased or otherwise acquired shares of Millrose should contact the Firm prior to the December 8, 2026 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at [email protected] or [email protected].

Please visit our website at http://www.gme-law.com for more information about the firm.