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Press releases published on May 14, 2025

Gain Therapeutics Reports Financial Results for First Quarter 2025 and Provides Corporate Update

Gain Therapeutics Reports Financial Results for First Quarter 2025 and Provides Corporate Update

BETHESDA, Md., May 14, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, …

Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYNTM Gene Therapy to Treat Wounds in Painful Skin Disorder

Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYNTM Gene Therapy to Treat Wounds in Painful Skin Disorder

- ZEVASKYN, the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), now commercially available in the U.S. - - Ann …

BioVie to Host Virtual KOL Event to Discuss the Phase 2 Study of Bezisterim for the Treatment of Parkinson's Disease on May 28, 2025

BioVie to Host Virtual KOL Event to Discuss the Phase 2 Study of Bezisterim for the Treatment of Parkinson's Disease on May 28, 2025

CARSON CITY, Nev., May 14, 2025 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver …

Moleculin Reports First Quarter 2025 Financial Results and Provides Corporate Update

Moleculin Reports First Quarter 2025 Financial Results and Provides Corporate Update

Enrollment and dosing underway in Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin (naxtarubicin) for the treatment of R/R AML  Regulatory and site selection progress to date supports interim data readout expected in the second half of …

Arbutus Reports First Quarter 2025 Financial Results and Provides Corporate Update

Arbutus Reports First Quarter 2025 Financial Results and Provides Corporate Update

Imdusiran combination therapy has functionally cured 8 patients with chronic hepatitis B (cHBV) to date, including 2 patients who received no interferon AB-101, oral small-molecule PD-L1 inhibitor, shown generally safe and well-tolerated with evidence of …

Inozyme Pharma Reports First Quarter 2025 Financial Results and Provides Business Highlights

Inozyme Pharma Reports First Quarter 2025 Financial Results and Provides Business Highlights

- Interim data from ENERGY 3 trial highlight INZ-701’s potential to modify disease course in ENPP1 Deficiency, with sustained phosphate increases and favorable safety and immunogenicity profile to date - - ENERGY 3 trial on track for topline data in first …

Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site

Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site

-- First patient expected to be dosed during Q2 2025 -- -- Trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in both plexiform neurofibromas and cutaneous neurofibromas -- -- Starting dose of 4mg tablet …

Invivyd Files Citizen Petition Urging FDA to Focus on Monoclonal Antibodies For Endemic-Virus-Era COVID-19 Prevention, and to Re-Assess COVID-19 Vaccine Efficacy

Invivyd Files Citizen Petition Urging FDA to Focus on Monoclonal Antibodies For Endemic-Virus-Era COVID-19 Prevention, and to Re-Assess COVID-19 Vaccine Efficacy

WALTHAM, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA) calling on the Agency to evolve from historical approaches to the development …

Benitec Biopharma Releases Third Quarter 2025 Financial Results

Benitec Biopharma Releases Third Quarter 2025 Financial Results

HAYWARD, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace …

Tisento Highlights Two Venues Advancing Patient-Focused Therapeutic Development for Mitochondrial Diseases

Tisento Highlights Two Venues Advancing Patient-Focused Therapeutic Development for Mitochondrial Diseases

Tisento to Present at the “Primary Mitochondrial Diseases” Therapeutic Development Workshop Hosted by the Reagan-Udall Foundation for the FDA on May 22, 2025 Tisento to Sponsor the First Externally Led Patient-Focused Drug Development Meeting Dedicated to …

Foghorn Therapeutics Provides First Quarter 2025 Financial and Corporate Update

Foghorn Therapeutics Provides First Quarter 2025 Financial and Corporate Update

FHD-909 (LY4050784) advancing in Phase 1 dose escalation trial in SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population Data presented at AACR show synergistic activity with FHD-909 in combination with …

Tilray Brands Announces the Launch of XMG Atomic Sours: New THC Beverages and Edibles

Tilray Brands Announces the Launch of XMG Atomic Sours: New THC Beverages and Edibles

TORONTO, May 14, 2025 (GLOBE NEWSWIRE) -- Tilray Brands, Inc. (Nasdaq: TLRY; TSX: TLRY), a global lifestyle and consumer packaged goods company at the forefront of beverage, cannabis and wellness industries, is excited to announce that its wholly-owned …

Ligand to Ring the Nasdaq Opening Bell on May 19, 2025

Ligand to Ring the Nasdaq Opening Bell on May 19, 2025

JUPITER, Fla., May 14, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that the company will ring The Nasdaq Stock Market Opening Bell on Monday, May 19, 2025. CEO Todd Davis will be joined by members of Ligand’s …

BioCryst Announces FDA Acceptance of NDA for ORLADEYO® (berotralstat) Oral Granules in Patients with Hereditary Angioedema Aged 2 to 11 Years

BioCryst Announces FDA Acceptance of NDA for ORLADEYO® (berotralstat) Oral Granules in Patients with Hereditary Angioedema Aged 2 to 11 Years

–FDA grants Priority Review of application, with PDUFA target action date of September 12, 2025– –ORLADEYO would be the first targeted oral prophylactic therapy for patients with HAE under the age of 12, if approved– RESEARCH TRIANGLE PARK, N.C., May 14, …

OrthoPediatrics Corp. Continued Leading Sponsorship at 2025 POSNA Annual Meeting

OrthoPediatrics Corp. Continued Leading Sponsorship at 2025 POSNA Annual Meeting

WARSAW, Ind., May 14, 2025 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced its continued support of the 2025 …

Ocular Therapeutix™ to Participate in Upcoming Investor Conferences

Ocular Therapeutix™ to Participate in Upcoming Investor Conferences

BEDFORD, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a fully-integrated biopharmaceutical company committed to redefining the retina experience, today announced participation in several upcoming investor …

Tonix Pharmaceuticals Announces Appointment of Joseph Hand, Esq., as General Counsel and Executive Vice President of Operations

Tonix Pharmaceuticals Announces Appointment of Joseph Hand, Esq., as General Counsel and Executive Vice President of Operations

Mr. Hand brings more than 20 years of strategic legal and business leadership experience across multiple functions in the biopharmaceutical industry, including nearly a decade in senior executive positions at Celgene Served on Celgene’s Executive Committee …

Sanara MedTech Inc. Reports First Quarter 2025 Financial Results (Unaudited)

Sanara MedTech Inc. Reports First Quarter 2025 Financial Results (Unaudited)

Q1 Net Revenue Increased 26% Year-Over-Year FORT WORTH, TX, May 14, 2025 (GLOBE NEWSWIRE) -- Sanara MedTech Inc. (“Sanara,” the “Company,” “we,” “our” or “us”) (Nasdaq: SMTI), a medical technology company focused on developing and commercializing …

Metagenomi Presents Data Highlighting Advancements in Next-Generation Genome Editing Technologies at ASGCT Annual Meeting 2025

Metagenomi Presents Data Highlighting Advancements in Next-Generation Genome Editing Technologies at ASGCT Annual Meeting 2025

- Potential best-in-class extrahepatic in vivo gene editing with all-in-one delivery to the central nervous system (CNS) is a critical milestone for the treatment of neurological disorders - - Advancements demonstrate the ability to specifically integrate …

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