Tonix Pharmaceuticals Presented Data on TONMYATM in Treating Patients with Fibromyalgia at the 2026 AAPM PainConnect Annual Meeting




Tonix Pharmaceuticals Presented Data on TONMYATM in Treating Patients with Fibromyalgia at the 2026 AAPM PainConnect Annual Meeting

TONMYA (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, was commercially launched in November 2025

Treatment with TONMYA provided statistically significant pain reduction in two Phase 3 trials and was generally well tolerated

BERKELEY HEIGHTS, N.J., March 09, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, presented data on TONMYA^TM (cyclobenzaprine HCl sublingual tablets), at the 2026 American Academy of Pain Medicine (AAPM) PainConnect Annual Meeting, in Salt Lake City, Utah.

“The data presented at the AAPM PainConnect Annual Meeting support TONMYA’s role as a safe and effective non-opioid analgesic for daily use at bedtime in fibromyalgia,^1,2” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “TONMYA is designed to target nonrestorative sleep and is a first-in-class tertiary amine tricyclic for long-term use. As the first approved therapy for fibromyalgia in over 15 years, TONMYA is an alternative to three currently FDA-approved medicines, which are limited by side effects, adherence, and high discontinuation rates. TONMYA’s unique sublingual formulation enables cyclobenzaprine to bypass first-pass hepatic metabolism. Relative to off-label oral swallowed cyclobenzaprine, TONMYA treatment results in reduced formation of the active, persistent metabolite norcyclobenzaprine, which we believe interferes with the durability of cyclobenzaprine’s treatment effect in fibromyalgia with long term dosing. Oral cyclobenzaprine failed in development because it provided only short-term (one month) benefit³, which is not sufficient for the treatment of fibromyalgia, a chronic condition that requires a sustained treatment effect.”

Data presented at the AAPM PainConnect Annual Meeting are from the Phase 3 RESILIENT trial, a 14-week randomized, double-blind, placebo-controlled study that assessed the safety and efficacy of TONMYA in 457 patients who met the 2016 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia. In addition to showing a statistically significant reduction in mean daily pain at 14 weeks, TONMYA treatment resulted in an increase over placebo in the number of individuals with a 30% reduction in daily pain, which is considered a clinically meaningful response. The most common adverse events were mild and self-limited oral cavity reactions that uncommonly led to study withdrawal. TONMYA was approved by the FDA in August 2025 in part based on the Phase 3 RESILIENT trial results and was commercially launched in the U.S. in November 2025.

A copy of the Company’s poster presentation, “Treatment with TNX-102 SL Produces Clinically Meaningful Improvements in Patient-Centered Outcomes in Fibromyalgia,” is available under the Presentations tab of the Tonix website at https://ir.tonixpharma.com/presentations.

Citations

¹Carette S, et al. Arthritis Rheum. 1994. 37(1):32-40. doi: 10.1002/art.1780370106.
²Lederman S, et al. Arthritis Care Res (Hoboken). 2023. 75(11):2359-2368. doi: 10.1002/acr.25142.
³Lederman S, et al. Pain Med. 2026. 27(1):86-94. doi: 10.1093/pm/pnaf089.

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About TONMYA™ (cyclobenzaprine HCl sublingual tablets)

TONMYA (cyclobenzaprine HCl sublingual tablets) is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT_2A serotonergic, α₁-adrenergic, H₁-histaminergic, and M₁-muscarinic receptors, TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress reaction (ASR)/acute stress disorder (ASD), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034/2035.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA^TM (cyclobenzaprine HCl sublingual tablets 2.8 mg), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® and Tosymra®. Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.

*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Tonmya, Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com  

Media Contacts
Deborah Elson
Tonix Pharmaceuticals 
deborah.elson@tonixpharma.com

Ray Jordan
Putnam Insights
ray@putnaminsights.com  

INDICATION

TONMYA is indicated for the treatment of fibromyalgia in adults.

CONTRAINDICATIONS

TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.

WARNINGS AND PRECAUTIONS

Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.

Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.

Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.

Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.

CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS

MAO inhibitors: Life-threatening interactions may occur. Other serotonergic drugs: Serotonin syndrome has been reported. CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced. Tramadol: Seizure risk may be enhanced. Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED). Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition. Pediatric use: The safety and effectiveness of TONMYA have not been established. Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

Please see additional safety information in the full Prescribing Information.

To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Radiant Health Centers Announces Honorees for 40th Annual Gala Celebrating Four Decades of Compassionate Care




Radiant Health Centers Announces Honorees for 40th Annual Gala Celebrating Four Decades of Compassionate Care

Jai Rodriguez and Harper Steele Headline Evening Honoring Cultural Impact, Legacy Leadership, and Community Hope

Irvine, CA, March 09, 2026 (GLOBE NEWSWIRE) — Radiant Health Centers, Orange County’s largest provider of inclusive health and social services with a special focus on the LGBTQ+ community and people living with and affected by HIV, announced today that its 40th Annual Gala will take place on Saturday, March 21, 2026 at 6:00 p.m. at [AV] Irvine (16500 Scientific Way, Irvine, CA 92618).

Actor and LGBTQ+ advocate Jai Rodriguez will be honored with the 2026 Cultural Impact Award at Radiant Health Centers’ 40th Anniversary Gala for his role in expanding visibility and representation.

The milestone evening – “Hollywood: Beyond the Velvet Rope” – will bring together community leaders, advocates, and supporters for a red-carpet celebration of Radiant’s impact while raising critical funds to expand access to stigma-free, compassionate care across Orange County.

“For four decades, Radiant has been a lifeline, connecting thousands each year to medical care, mental health support, housing, food, and HIV testing and treatment,” said Edwin Rivera-Cortez, Chief Development and Communications Officer. “This anniversary is a milestone, but it is also a reminder that the need for inclusive, stigma-free services has never been greater. By honoring individuals like Jai Rodriguez and Harper Steele – along with several extraordinary community leaders – we celebrate the power of visibility, compassion, and leadership to transform lives.”

2026 Cultural Impact Award Honoree

Jai Rodriguez

Radiant will present the 2026 Cultural Impact Award to actor, musician, and LGBTQ+ visibility trailblazer Jai Rodriguez, best known as the culture guide on the groundbreaking Emmy Award–winning series Queer Eye for the Straight Guy.

The Radiant Cultural Impact Award honors an artist and advocate whose work has shifted culture by expanding visibility, challenging stereotypes, and helping create a more inclusive and compassionate world.

Rodriguez’s career helped open doors for LGBTQ+ representation in mainstream entertainment at a pivotal moment in television history. Beyond his work on screen and stage, he has used his platform to advocate for people impacted by HIV/AIDS – speaking openly about stigma and supporting awareness, prevention, testing, and access to treatment.

Rodriguez will appear live and perform during the Gala program.

2026 Radiant Compassion Award Honoree

Harper Steele

Radiant will present the 2026 Radiant Compassion Award to Emmy-winning writer and storyteller Harper Steele, whose career has helped shape American comedy while expanding public understanding of identity, friendship, and belonging.

A longtime writer for Saturday Night Live, Steele contributed to some of the show’s most iconic eras and served as head writer from 2004–2008. In 2024, she starred in the acclaimed documentary Will & Harper with longtime friend Will Ferrell, chronicling a cross-country road trip following her transition.

The film offered audiences a deeply human story about friendship, allyship, and acceptance – bringing compassion into the national conversation in a way only storytelling can.

Steele will appear live during the Gala program.

Honoring Legacy and Community Impact

In addition to recognizing leaders in entertainment and culture, Radiant will also honor individuals whose leadership and courage have helped shape the organization and strengthen the community it serves.

Legacy Award Honorees

Dr. Duane Vajgrt and Jeff Benedick

Radiant will present the Legacy Award to Dr. Duane Vajgrt and Jeff Benedick, whose leadership during the early years of the HIV/AIDS crisis helped lay the foundation for what would become Radiant Health Centers.

In 1986, at a time when fear and stigma were widespread and resources were scarce, their work with AIDS Services Foundation helped ensure that individuals living with HIV had access to compassionate care and essential support. Their commitment helped transform an emergency response into a lasting institution dedicated to health equity and dignity.

Dr. Adrienne Matros and Rick Matros

Radiant will also present the Legacy Award to Dr. Adrienne Matros and Rick Matros, whose decades of advocacy, generosity, and leadership have strengthened Radiant’s mission.

Adrienne’s early work supporting individuals and families affected by HIV/AIDS during graduate school, combined with Rick’s experience in the long-term care field, helped shape their lifelong commitment to compassionate healthcare access. Since moving to Orange County in 2000, the Matros family has been steadfast partners in advancing Radiant’s work.

Beacon of Hope Award Honoree

Raven Kim

Radiant will present the Beacon of Hope Award to Raven Kim, a young transgender community member whose courage and authenticity reflect the spirit of hope that defines Radiant’s mission.

Raven’s journey of self-discovery and resilience – shaped by personal loss, family support, and a commitment to living authentically – has inspired those around her. Today she volunteers in Radiant’s food pantry, directly supporting patients and families who rely on the organization’s programs for stability and care.

By sharing her story and living openly, Raven offers encouragement to other young people navigating identity, belonging, and self-worth.

As her story reminds us: Hope is not abstract – it lives in the courage to live truthfully.

Guests will hear a special video message from Raven during the Gala program.

A Red-Carpet Night With Real Impact

The 40th Annual Radiant Health Centers Gala will feature an inspiring program, celebrity entertainment, and both silent and live auctions.

Proceeds support Radiant’s integrated care model – connecting more than 6,000 individuals and families each year to comprehensive services including:

• HIV testing and treatment
• prevention and education programs
• mental health counseling
• housing support
• transportation assistance
• food and nutrition services
• family planning and primary healthcare

For forty years, Radiant Health Centers has stood as a place where individuals can find dignity, support, and stigma-free healthcare. The Gala helps ensure that this life-saving work continues for generations to come.

EVENT DETAILS

Radiant Health Centers 40th Annual Gala

Hollywood: Beyond the Velvet Rope

Saturday, March 21, 2026 – 6:00 p.m.

[AV] Irvine

16500 Scientific Way

Irvine, CA 92618

Tickets and sponsorships information:

http://onecau.se/_fr2521

(949) 809-5700

Media credential and information requests:

eriveracortez@radianthealthcenters.org

(949) 809-5772

NOTE TO EDITORS:

Credentialed media attendance is limited. Interview requests and photo/video opportunities (red-carpet arrivals, award presentations, and on-stage moments) may be available by advance arrangement. Please RSVP in advance.

Emmy-winning writer Harper Steele, known for her work on Saturday Night Live and the documentary Will & Harper, will receive the 2026 Radiant Compassion Award at Radiant Health Centers’ 40th Annual Gala.

About Radiant Health Centers

Radiant Health Centers (formerly AIDS Services Foundation of Orange County) is the region’s only FQHC Look-Alike focused on LGBTQ+ health and individuals living with or affected by HIV. For 40 years, Radiant has proudly served Orange County with medical care, behavioral health, harm reduction, case management, HIV/STI testing, and prevention services — all grounded in compassion, dignity, and health equity.

Press Inquiries

Edwin Rivera-Cortez
eriveracortez [at] radianthealthcenters.org
9498095700
https://radianthealthcenters.org
17982 Sky Park Cir Ste J

A video accompanying this announcement is available here: https://youtube.com/watch?v=0WFHTsBA0LE

GENFIT Receives FDA Orphan Drug Designation for NTZ for the treatment of ACLF    




GENFIT Receives FDA Orphan Drug Designation for NTZ for the treatment of ACLF    

• FDA grants Orphan Drug Designation (ODD) for NTZ for ACLF, a severe condition with no approved therapies
• NTZ is being advanced in ACLF through its G1090N reformulation, designed to unlock its clinical potential for patients facing this life‑threatening condition
• This regulatory milestone follows favorable Phase 1 safety results and strong anti-inflammatory activity observed in ex vivo assays on samples from healthy volunteers and cirrhotic donors

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), March 9, 2026 – GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted ODD to NTZ (nitazoxanide), its investigational small-molecule drug candidate developed as a new formulation for the treatment of Acute-on-Chronic Liver Failure (ACLF).

G1090N is GENFIT’s lead investigational program within the ACLF segment of its pipeline. The FDA’s ODD recognizes the potential of G1090N’s active substance to address this severe, rare condition characterized by rapid deterioration, systemic inflammation, and high short-term mortality.

This designation follows recent Phase 1 data demonstrating a favorable safety and tolerability profile in healthy volunteers, as well as compelling anti-inflammatory activity across ex vivo models, providing a solid foundation for advancing the program toward initiation of Phase 2 clinical development, targeted for the second half of 2026. ODD also provides development incentives, including FDA regulatory guidance, certain user fee reductions, and eligibility for seven-year U.S. market exclusivity for the designated indication upon FDA approval.

END
ABOUT GENFIT

GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT’s expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.¹   Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT’s largest shareholders, acquiring an 8% stake in the Company’s capital. www.genfit.com

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements with respect to GENFIT, including, but not limited to statements regarding the therapeutic potential of G1090N, the significance and implications of the U.S. Food and Drug Administration’s Orphan Drug Designation, the expected benefits associated with such designation, including regulatory incentives and potential market exclusivity, the advancement of G1090N into further clinical development, the anticipated initiation and timing of a Phase 2 clinical trial, and GENFIT’s overall development strategy and prospects in Acute-on-Chronic Liver Failure. The use of certain words, such as “believe”, “potential”, “expect”, “target”, “may”, “will”, “should”, “could”, “if” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Risk Factors and Internal Control” of the Company’s 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers (“AMF”), which is available on GENFIT’s website (www.genfit.fr) and the AMF’s website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACTS

GENFIT | Investors
Jean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 |
jean-christophe.marcoux@genfit.com

GENFIT | Media
Bruno ARABIAN – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.fr

Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com

  
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com       

1 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo®

Attachment

• GENFIT Receives FDA Orphan Drug Designation for NTZ for the treatment of ACLF

HNL Lab Medicine’s Career Connections Program Builds the Next Generation of Clinical Laboratory Professionals




HNL Lab Medicine’s Career Connections Program Builds the Next Generation of Clinical Laboratory Professionals

ALLENTOWN, Pa., March 09, 2026 (GLOBE NEWSWIRE) — HNL Lab Medicine is helping address the national shortage of clinical laboratory professionals through its Career Connections program, a hands-on initiative that introduces college students to careers in laboratory science and provides a closer look at the critical role laboratories play in patient care.

Led by Katie Moore, MLS (ASCP)ᶜᵐ, Training and Development Coordinator at HNL Lab Medicine, Career Connections offers immersive, two-day experiences held twice annually during college winter break. The program connects students directly with laboratory professionals through department tours, shadowing opportunities, a networking luncheon, and career development discussions at HNL Lab Medicine’s headquarters in Allentown, Pennsylvania.

As a leading diagnostic laboratory, HNL Lab Medicine plays a critical role in supporting healthcare providers throughout Pennsylvania. Programs like Career Connections help ensure the region continues to have a strong pipeline of trained laboratory professionals who support patient diagnosis, treatment decisions, and public health.

Clinical laboratories across the United States continue to face significant workforce shortages due to reimbursement pressures, hospital consolidation, rising education costs, and declining program enrollment. These factors, combined with low public visibility and an aging workforce, have created ongoing staffing challenges across the country. Career Connections was developed to help address this trend by increasing awareness of the profession and creating meaningful pathways for students interested in science, technology, engineering, arts, and mathematics (STEAM).

“It has been my privilege to leverage my background in education and medical laboratory science to develop programs that engage STEAM-interested students and strengthen community partnerships, with the goal of addressing workforce shortages,” said Moore. “I am deeply grateful to HNL Lab Medicine leadership for their strong commitment and participation, creating a snowball effect that allows laboratory staff the time to participate in programs and expand our reach and impact.”

The program began as a small partnership with a local university and has since grown to include students from multiple colleges and universities across the region. Participants explore a wide range of clinical laboratory departments, engage with professionals working across specialties, and collaborate on reflective projects such as “A Day in the Life” presentations that highlight their learning experiences. Professional development sessions are also incorporated to help students better understand career pathways, education requirements, and workforce expectations.

Importantly, Career Connections is designed to give students space to explore and make informed decisions about their future.

“The goal is exposure and understanding, so students can confidently decide whether a clinical laboratory career aligns with their interests and strengths,” Moore added.

Students who have participated in Career Connections consistently describe the experience as eye-opening and impactful.

“I was fully immersed in the daily work of the lab. Seeing the importance of what happens behind the scenes in healthcare was eye-opening. This opportunity was truly life changing,” said Carinne Frable, DeSales University ’27.

Another student shared, “I just wanted to thank you for hosting such an informative and valuable event for college students such as myself! I have a newfound respect for the work conducted by HNL Lab Medicine, along with each individual department’s efforts in contributing to the world of healthcare.”

Career Connections is one of several student-focused initiatives supported by HNL Lab Medicine, reflecting the organization’s long-standing commitment to education, workforce development, and community partnership. By investing in early exposure and mentorship, HNL Lab Medicine is helping rebuild the pipeline of skilled laboratory professionals essential to patient care.

For more information about HNL Lab Medicine, visit hnl.com.

About HNL Lab Medicine

Operating for more than 25 years, HNL Lab Medicine is a leading multi-regional, full-service medical laboratory providing testing and related services to physician offices, hospitals, long-term care facilities, employers, and industrial accounts throughout Pennsylvania. HNL Lab Medicine has more than 50 patient service centers in Pennsylvania and 31 acute care laboratories within our partners’ hospital sites. The HNL Lab Medicine team consists of more than 2,022 employees, including more than 109 industry-leading pathologists and scientific directors. Our multidisciplinary team of experts is focused on providing expert medical and technical diagnostic guidance so that patients can be diagnosed and treated faster. Learn more at HNL.com and follow us on Facebook, TikTok, Vimeo and LinkedIn.

Media Contact:
Leanne Anderson
laenne.aquino@hnl.com
484-425-5047

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f9358c75-5210-471f-b5d0-5d161b8d9769

CenTrak Showcases Next Generation of AI-Enhanced Location Intelligence Platform at HIMSS 2026




CenTrak Showcases Next Generation of AI-Enhanced Location Intelligence Platform at HIMSS 2026

New AI-powered insights and platform innovations expand how healthcare organizations use real-time location data to improve safety, streamline operations, and maximize RTLS value

NEWTOWN, Pa., March 09, 2026 (GLOBE NEWSWIRE) — CenTrak, a leader in real-time location systems (RTLS) for healthcare, will debut its next generation of products at the HIMSS Global Health Conference & Exhibition, March 9–12 in Las Vegas (Booth #3009). CenTrak will demonstrate a connected set of technological innovations across the platform designed to help healthcare organizations translate real-time location data into meaningful insights across staff safety, patient protection, and operational performance.

At HIMSS 2026, attendees will experience live, in-booth demonstrations of Bluetooth^® Low Energy (BLE)-enabled workflows that mirror real clinical scenarios, from initiating a mobile duress alert using a wearable staff badge or mobile app, to understanding the movement and utilization of critical medical equipment. These demonstrations show how location intelligence goes beyond simply locating items, empowering caregivers to make decisions that improve safety, efficiency, and patient care.

“With CenTrak’s latest innovations, such as mobile applications for staff and low-cost, disposable tags for assets, patients, and visitors, healthcare organizations can expand the utility of their RTLS investments while leveraging AI-enhanced reporting to maximize ongoing value and return on adoption,” said Crystal Ryan, Chief Commercial Officer at CenTrak. “We’ve evolved our Connect^RT platform to help organizations act on location-driven insights immediately, whether that means responding to a duress event, efficiently managing a fleet of mobile medical equipment, or monitoring a vulnerable patient, without adding complexity to the technology ecosystem. Our goal is to provide a single, comprehensive platform that gives healthcare teams the confidence and clarity they need to focus on what matters most, delivering high-quality care.”

Highlighted innovations at HIMSS 2026 include:

• Duress^RT Mobile App – Enables discreet duress alerts from mobile phones, extending staff protection beyond facility walls to parking lots, courtyards, home health visits, and more.
• CenTrak Safety Bracelet – A watch-like RTLS wearable designed for continuous monitoring of high-risk or wandering patients in behavioral health and senior care environments.
• AI-Enhanced Assets^RT – Leverages AI to analyze data across all assets, uncovering meaningful trends and patterns that help hospitals optimize workflows and reduce inefficiencies. Includes natural language search and reporting to quickly locate devices and extract actionable insights.
• Next-Generation BLE Sticker Tags – Ultra-thin, economical, and disposable; these tags make it easy to track more items, from phones and tablets to patients and visitors, extending the reach and impact of any RTLS system.

These future-ready updates are designed to continually expand customer value and incorporate the latest RTLS innovations, while maintaining an open platform that enables seamless interoperability with EMR, nurse call, CMMS, and other essential hospital systems.

Join CenTrak at HIMSS 2026 (Booth #3009) in Las Vegas, March 9–12. Experience our newest products firsthand in the in-booth usability lab, get early access to cutting-edge software updates, and explore customized value assessments to understand the potential impact and return on adoption for your organization.

About CenTrak
CenTrak empowers healthcare leaders with actionable data to increase productivity, reduce operating costs, and transform patient care via market-leading locating and sensing IoT solutions. The organization was recognized as the 2024 IoT Health & Wellness Company of the Year by IoT Breakthrough and the 2024 Company of the Year in global healthcare RTLS by Frost & Sullivan. Founded in 2007, CenTrak is trusted by more than 2,000 healthcare organizations around the world. For more information, visit CenTrak.com.

CONTACT: Contact: Heather Fretz, hfretz@bnoinc.com

MannKind to Present New Data From Pediatric and Adult Studies of Afrezza® at ATTD 2026




MannKind to Present New Data From Pediatric and Adult Studies of Afrezza® at ATTD 2026

• Presentations highlight real‑world dosing and titration patterns in youth, and post‑prandial glucose management strategies using inhaled insulin in both adults and youth with T1D
• Data to be featured across oral and poster sessions at the Advanced Technologies & Treatments for Diabetes Conference (ATTD)
• PDUFA target action date for Afrezza in children and adolescents living with type 1 or type 2 diabetes set for May 29, 2026

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 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 that new clinical and real‑world data related to Afrezza^® (insulin human) Inhalation Powder will be presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2026), taking place March 11–14, 2026, in Barcelona, Spain.

“We look forward to presenting important new data for Afrezza at this year’s ATTD and contributing to the scientific dialogue around meal-time diabetes management across both adult and pediatric populations,” said Kevin Kaiserman, MD, Senior Vice President, Therapeutic Area Head, Diabetes for MannKind Corporation. “ATTD is a key forum for advancing how clinicians think about insulin use at meals, and we value the opportunity to engage with the global diabetes community on this important topic.”

The data will include two oral presentations, one comparing the efficacy of Afrezza for post-prandial glucose control across several different clinical studies, and the second one highlighting data from the INHALE-1 study of Afrezza in pediatric patients with type 1 or type 2 diabetes. A poster will also be presented at the meeting highlighting dosing and titration patterns of inhaled insulin from the INHALE1 study of Afrezza in children and adolescents, where patients were initiated at an approximately 2:1 conversion from rapid-acting insulin analogs (RAA) in children and adolescents. Together, these presentations reflect MannKind’s continued commitment to advancing the understanding of how inhaled insulin can be used to support individualized diabetes management across patient populations.

“The INHALE‑1 study was designed to better characterize how inhaled insulin is initiated, used and adjusted over time in pediatric patients with diabetes,” said Roy Beck, MD, PhD, Medical Director of the Jaeb Center for Health Research. “By examining the clinical study data, we can gain additional insights that help set practical expectations for clinicians and support thoughtful discussions at ATTD about real-world considerations in pediatric diabetes care.”

The following data will be presented at ATTD 2026:

Inhaled Insulin Dosing & Post Prandial Glucose Excursions Across Multiple Studies
Thursday, March 12, 2026 – 5:10pm CET in Hall 212
Presenter: Kevin Kaiserman, MD

Refining Care of Type 1 Diabetes: Inhaled Insulin Use in Pediatrics – INHALE-1 Study
Saturday, March 14, 2026 – 10:30am CET in Hall 114
Presenter: Roy Beck, MD, PhD

Inhaled Technosphere Insulin Dosing in Youth with T1D
ePoster available via gallery on UNLOK, the mobile app, or at any of the ePoster stations

Afrezza Pediatric Indication: FDA Review in Progress
In October 2025, the FDA accepted for review a supplemental Biologics License Application (sBLA) for Afrezza in children and adolescents between the ages of 4-17 who are living with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026. If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy.

About Afrezza
Afrezza^® (pronounced uh-frezz-uh) Inhalation Powder is the only ultra rapid-acting inhaled insulin approved by the U.S. Food and Drug Administration to improve glycemic control in adult patients with diabetes mellitus. Administered at the beginning of meals using a small, portable inhaler, Afrezza delivers insulin via MannKind’s proprietary Technosphere^® technology, enabling ultra-rapid absorption through the lungs. Afrezza has a fast onset of action and a short duration, more closely mirroring the body’s natural insulin response to meals.

INDICATION AND IMPORTANT SAFETY INFORMATION WITH WARNINGS

Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus.

Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking.

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE

• Acute bronchospasm has been observed in Afrezza-treated patients with asthma and chronic obstructive pulmonary disease (COPD)
• Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD
• Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV₁) to identify potential lung disease in all patients.

Afrezza is contraindicated: during episodes of hypoglycemia, in patients with chronic lung disease (such as asthma or COPD) because of the risk of acute bronchospasm, and in patients with previous severe hypersensitivity reaction to regular human insulin product or any of the inactive ingredients in Afrezza. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Afrezza.

In a study of patients with asthma whose bronchodilators were temporarily withheld for assessment, bronchoconstriction and wheezing following Afrezza dosing was reported. Before initiating therapy, evaluate all patients with a medical history, physical examination, and spirometry (FEV₁) to identify potential underlying lung disease. Do not use in patients with chronic lung disease such as asthma or COPD.

Changes in an insulin regimen (e.g., insulin strength, manufacturer, injection site or type, or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. If clinically indicated, make any necessary changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. For patients with type 2 diabetes, dosage modifications of concomitant oral antidiabetic treatment may be needed.

Hypoglycemia is the most common adverse reaction associated with insulins, including Afrezza. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly, and symptoms may differ across patients and change over time in the same patient. Advise patients to recognize and manage hypoglycemia and self-monitor glucose. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of glucose monitoring is recommended.

Afrezza causes a decline in lung pulmonary function over time as measured by FEV₁. In clinical trials excluding patients with chronic lung disease and lasting up to 2 years, Afrezza-treated patients experienced a small (40 mL) but greater FEV₁ decline than comparator-treated patients. Assess pulmonary function with spirometry at baseline, after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. In patients who have a decline of ≥20% in FEV₁ from baseline, consider discontinuing Afrezza. Consider more frequent lung function assessment in patients with pulmonary symptoms, e.g., wheezing, bronchospasm, breathing difficulties, or persistent or recurring cough. If symptoms persist, discontinue Afrezza.

In clinical trials, 2 cases of lung cancer were observed in patients exposed to Afrezza while no cases were reported for the comparators. In both cases, a prior history of heavy tobacco use was identified as a risk factor for lung cancer. Two additional cases of lung cancer (squamous cell and lung blastoma) were reported in non-smokers exposed to Afrezza after the trial completion. These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors. In patients with active lung cancer, a prior history of lung cancer, or in patients at risk of lung cancer, consider whether the benefits of Afrezza use outweigh this potential risk.

In clinical trials enrolling patients with type 1 diabetes, diabetic ketoacidosis (DKA) was more common in Afrezza-treated patients (0.43%; n=13) than in comparator-treated patients (0.14%; n=3). Patients with type 1 diabetes should always use Afrezza concomitantly with basal insulin. In patients at risk for DKA, such as those with an acute illness or infection, increase the frequency of glucose monitoring and consider discontinuing Afrezza and giving insulin using an alternate route of administration.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products. If hypersensitivity reactions occur, discontinue Afrezza, treat per standard of care and monitor until symptoms and signs resolve.

All insulin products, including Afrezza, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Observe these patients for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the TZD should be considered.

Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.

Please see additional Important Safety Information, Full Prescribing Information, including BOXED WARNING, available on Afrezza.com/safety.

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 the anticipated presentation of new clinical data regarding inhaled insulin and the potential timing of regulatory action. 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 issues that develop in the review and approval by a regulatory agency may subject us to unanticipated delays, 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.

AFREZZA and MANNKIND are registered trademarks of MannKind Corporation.

CONTACT: MannKind Contacts:

Media Relations:
Christie Iacangelo
(818) 292-3500
media@mnkd.com

Investor Relations:
Kate Miranda
(617) 921-5461
ir@mnkd.com

Junshi Biosciences Announces NMPA Acceptance of New Drug Applications for Toripalimab Injection (Subcutaneous) Across 12 Indications




Junshi Biosciences Announces NMPA Acceptance of New Drug Applications for Toripalimab Injection (Subcutaneous) Across 12 Indications

SHANGHAI, March 09, 2026 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the new drug applications (the “NDAs”) for the company’s product, toripalimab injection (subcutaneous injection [code: JS001sc]), for 12 indications in the treatment of tumors has been accepted by the National Medical Products Administration (“NMPA”). JS001sc is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage.

According to data released by GLOBOCAN 2022, in 2022, there were 4.8247 million new cancer cases and 2.5742 million cancer-related deaths in China. Immunotherapy (I-O), represented by anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various malignant tumors, including lung cancer, breast cancer, liver cancer, esophageal cancer, and nasopharyngeal carcinoma. Now, immunotherapy covers nearly all stages of treatment for cancer patients, encompassing adjuvant/neoadjuvant treatment for early-stage tumors, consolidation treatment after radical chemoradiation for locally advanced tumors, and first-line to last-line treatments for advanced tumors. Currently, most immunotherapy drugs in China are administered intravenously, and this not only requires lengthy infusion times, but also imposes significant inconveniences on patients. There is an urgent clinical need for more convenient administration methods for immunotherapy.

Independently developed by Junshi Biosciences, JS001sc injection is a subcutaneous injection based on the marketed product toripalimab injection (code: JS001) that is expected to enhance convenience for patients. The 12 indications in the JS001sc NDAs cover all currently approved indications of toripalimab injection in the Chinese Mainland.

The NDA is mainly based on the JS001sc-002-III-NSCLC Study (NCT06505837), a multi-center, open-label, randomized phase 3 clinical study led by principal investigator Professor Lin WU from Hunan Cancer Hospital. The study aimed to compare the exposure, efficacy and safety of JS001sc plus chemotherapy versus JS001 plus chemotherapy for the first-line treatment of recurrent or metastatic non-squamous non-small-cell lung cancer (“NSCLC”). The results showed that JS001sc’s exposure was non-inferior to that of JS001 with comparable efficacy and safety profiles. JS001sc-002-III-NSCLC was the first phase 3 clinical study of domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation. Further details will be presented at an upcoming international academic conference.

Professor Lin WU said, “The JS001sc-002-III-NSCLC study, as China’s first Phase 3 clinical trial of a domestically developed PD-1 monoclonal antibody in a subcutaneous formulation, confirmed that the subcutaneous administration method achieved statistical non-inferiority in drug exposure compared with intravenous administration, while demonstrating comparable efficacy and safety. This milestone not only validates the scientific rationale behind the pharmaceutical development of the subcutaneous formulation, but also provides a novel administration pathway for cancer immunotherapy at the clinical level. In the current era of holistic cancer management, treatment convenience and improved quality of life have become critical clinical priorities. The development and application of subcutaneous injection formulations are expected to significantly reduce dosing time, optimize healthcare resource allocation, and offer new technical support for advancing hierarchical medical systems and home-based treatment management. We anticipate the early approval of the subcutaneous formulation of toripalimab, which will further enrich China’s cancer immunotherapy landscape and ultimately benefit a broader population of cancer patients.”

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “We are excited that the NMPA has formally accepted the NDA for JS001sc covering all approved indications of TUOYI® (toripalimab). This signifies JS001sc’s potential to address multiple tumor types, including NSCLC, nasopharyngeal carcinoma, esophageal cancer, renal cancer, and liver cancer. It also marks another critical milestone in expanding toripalimab’s innovative and clinical value. As a subcutaneous formulation, JS001sc will substantially enhance dosing convenience, optimize patient treatment experiences, and improve long-term therapy adherence. Moving forward, we will actively advance the regulatory review process, consistently centering patient needs. Using our clinical evidence, we hope to leverage evidence-based medicine to advance high-quality development of China’s cancer therapies, ultimately delivering more accessible, convenient, and high-quality treatment options to patients.”

About JS001sc

JS001sc is a subcutaneous injection formulation developed by Junshi Biosciences based on the marketed product toripalimab injection (code: JS001). It is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage and is expected to bring convenient administration to patients. The 12 indications in the NDAs of JS001sc covers all currently approved indications of toripalimab injection in the Chinese Mainland.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 40 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19.

With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com.

Junshi Biosciences Contact Information

IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-6105 8800

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

InspireMD to Announce Fourth Quarter and Full Year 2025 Financial Results




InspireMD to Announce Fourth Quarter and Full Year 2025 Financial Results

MIAMI, March 09, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard^® Prime carotid stent system for the prevention of stroke, today announced that it will release its fourth quarter and full year 2025 financial results on Wednesday, March 18, 2026. In conjunction with the release, InspireMD will host a conference call and webcast at 8:30 a.m. Eastern Time to discuss its financial results and recent highlights.

A live audio webcast and an archive of the recording will be available through the Investors page of InspireMD’s corporate website at https://investors.inspiremd.com. Interested participants are encouraged to register more than 15 minutes before the start of the call.

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™ mesh technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on Nasdaq under the ticker symbol NSPR.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Investor Contact:
Webb Campbell
Gilmartin Group LLC
Webb@gilmartinir.com
investor-relations@inspiremd.com

Cloudcure Launches Companion App to Close Clinical Adherence Gap in Metabolic Health




Cloudcure Launches Companion App to Close Clinical Adherence Gap in Metabolic Health

Toronto, ON, March 09, 2026 (GLOBE NEWSWIRE) — Cloudcure, a specialized health platform dedicated to improving metabolic health through evidence-based, personalized medicine, has announced the launch of its new weight management app designed to serve as the clinical anchor for patients pursuing long-term metabolic transformation. The companion app is built to close the clinical adherence gap that has grown alongside the rise of transactional telehealth, where patients receive prescriptions but lack ongoing, human-led oversight and the behavioral structure required for long-term outcomes.

“Long-term outcomes require more than access to metabolic health therapy. They require adherence, monitoring, and behavioral stabilization,” said Salman Habib, a representative for Cloudcure. “Our companion app serves as the clinical anchor for that process, keeping patients supported through titration, side effects, and the day-to-day changes that make metabolic improvements sustainable.”

Closing the Clinical Adherence Gap
GLP-1 medications are reshaping medical weight care in Canada, yet many patients begin treatment with high expectations and minimal ongoing support. These therapies can be transformative, but long-term guidance is needed, especially as individuals navigate the physiological and psychological adjustments of metabolic treatment. Without structured oversight, patients often plateau prematurely, struggle with side effects, or ultimately disengage from their care plans.

Cloudcure aims to close this gap by treating weight health as a chronic, biology-driven condition rather than a short-term objective. Their model integrates medical intervention with behavioral science and compassionate, human-led support – a Digital Center of Excellence where clinical oversight and habit formation operate together within one cohesive, patient-centered framework.

A Unified Clinical Hub for Metabolic Health
The Cloudcure GLP-1 companion platform functions as the central patient interface for Cloudcure’s programs, offering integrated access to behavioral support, clinician-led weight loss, and progress tracking for sustainable metabolic health.

Key features of the app:

• Direct Clinical Access: Secure, 1:1 messaging with licensed Canadian clinicians specializing in medical weight care.
• Evidence-Based Curriculum: A psychology-driven program focused on stabilizing hunger signals and rewiring long-term habits.
• Integrated Care Management: Continuous oversight of medication titration, side effects, and refill readiness to ensure safety and adherence.
• Progress Visibility: Precise logging tools and milestone tracking that help patients visualize their clinical trajectory.
• Compassionate Patient Support: Readily accessible, judgment-free communication from the care team whenever guidance is needed.

Each feature is designed to work together to support metabolic healing, reduce treatment dropout rates, and reinforce the lifestyle changes necessary for metabolic reset.

Demonstrated Clinical Outcomes Across Patient Cohorts
Cloudcure’s integrated clinical model has shown strong outcomes across its patient population. Based on the company’s internal program data, many patients have achieved meaningful weight-loss progress under clinical care. The team emphasizes that while medication can play an important role, consistent engagement, behavioral reinforcement, and skilled clinical oversight are often key factors in supporting sustainable, long-term metabolic improvement.

“These outcomes reflect what happens when clinical oversight and behavioral adherence are treated as essential, not optional,” said Habib. “Medication can create momentum, but sustained metabolic improvement depends on consistent engagement and reinforcing the habits that keep patients progressing beyond the early phase.”

Laying the Foundation for Future Innovation
The launch of Cloudcure’s companion app marks the first step in the company’s broader roadmap that will introduce additional clinical and technological capabilities. The company is developing features that will deepen its ability to personalize patient care and proactively identify risk patterns that influence metabolic outcomes.

Future platform enhancements will include wellness and smart wearables to provide real-time biometric insights and AI-driven analytics capable of detecting metabolic patterns early. These tools are intended to strengthen patient adherence and improve safety monitoring.

“Our roadmap is focused on making metabolic care more continuous and personalized,” added Habib. “Wearable data and AI-driven insights can help clinicians identify early signals so we can intervene sooner and keep patients safely progressing toward long-term metabolic health.”

Beyond these innovations, Cloudcure is working to shift public and clinical perception away from short-term weight loss metrics and toward permanent metabolic transformation. Through continuous clinical monitoring, structured behavioral support, and a growing suite of digital tools, Cloudcure is redefining how metabolic health care is delivered in Canada. The company’s long-term vision remains focused on sustainable change, helping patients build healthier pathways and maintain progress beyond the initial stages of treatment.

To learn more about Cloudcure and to sign up, please visit http://www.joincloudcure.com.

About Cloudcure
Cloudcure is a Canadian-owned metabolic health platform dedicated to improving metabolic health by making evidence-based, personalized medicine more accessible. The company provides judgment-free care supported by a multidisciplinary team, combining clinical oversight with behavior-focused programming to help patients build long-term, sustainable health outcomes. Cloudcure’s approach integrates medical science, research, and digital health tools, with compassionate support designed to meet patients throughout their health journey.

Media Contact
Company Name: Cloudcure
Contact Person: Salman Habib
Contact Number: +1 647-948-6705
Email: salman@joincloudcure.com
Country: Canada
Website: http://www.joincloudcure.com

CONTACT: Media Contact
Company Name: Cloudcure
Contact Person: Salman Habib
Contact Number: +1 647-948-6705
Email: salman@joincloudcure.com
Country: Canada
Website: http://www.joincloudcure.com