COMMUNIQUÉS West-GlobeNewswire

Idebenone Accepted by FDA for Priority Review for Leber Hereditary Optic Neuropathy (LHON)
22/09/2025
FDA grants Priority Review to idebenone for Leber Hereditary Optic Neuropathy (LHON), a disease for which there are no existing approved treatments in the U.S.; action date of February 28, 2026 People living with LHON [...]
Connect Names Gretel von Son as Chief Operating Officer to Drive Growth in Entrepreneurship and Innovation
22/09/2025
SAN DIEGO, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Connect , a premier nonprofit organization in San Diego’s innovation ecosystem, dedicated to supporting entrepreneurs and cultivating thriving life science and technology [...]
Grace Therapeutics Pivotal Phase 3 STRIVE-ON Safety Trial Presented at 2025 Neurocritical Care Annual Meeting
22/09/2025
Presentation Highlighted Data Supporting Clinical Benefit of GTx-104 Compared to Orally Administered Nimodipine in the Treatment of aneurysmal Subarachnoid Hemorrhage (aSAH) PRINCETON, N.J., Sept. 22, 2025 (GLOBE [...]
BioCardia Announces Positive Preliminary Clinical Consultation with Japan Pharmaceutical and Medical Device Agency on Cell Therapy for Ischemic Heart Failure
22/09/2025
SUNNYVALE, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- BioCardia ® , Inc. [NASDAQ:BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces it has [...]
MediciNova Announces Completion of Patient Enrollment in COMBAT-ALS Phase 2b/3 Clinical Trial of MN-166 (ibudilast)
22/09/2025
~Patient Recruitment Closed~ LA JOLLA, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock [...]
Immutep Announces Research Collaboration with the George Washington University Cancer Center to Evaluate Neoadjuvant Efti
22/09/2025
GW Cancer Center to initiate Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in HR+/HER2-neg breast cancer patients Second investigator-initiated trial to [...]
Synergy CHC (NASDAQ: SNYR) Taps Former Coca-Cola Executive to Lead Strategic Partnerships; Appoints Veteran Costco Buyer to Board of Directors
22/09/2025
Board member Scott Woodburn transitions to Head of Strategic Partnerships to accelerate FOCUSfactor Energy Drink expansion Former Costco Buyer Teresa Thompson brings nearly 40 years of retail expertise in vitamins and [...]
Avalo Therapeutics Appoints Kevin R. Lind to Board of Directors
22/09/2025
WAYNE, Pa., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory [...]
MBX Biosciences Announces Once-Weekly Canvuparatide Achieved Primary Endpoint in Phase 2 Trial with 63% Responder Rate at 12 Weeks; 79% Responder Rate at 6 Months in Open-Label Extension
22/09/2025
Statistically significant responder rate achieved at 12 weeks with zero contribution from rescue therapy (PRN) and further improvement sustained in open-label extension (OLE) Positive findings in bone and kidney [...]
Helius (NASDAQ:HSDT) Begins Purchases of SOL, the Native Asset of Solana Blockchain
22/09/2025
NEWTOWN, Pa., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (the "Company" or "HSDT"), today announced its first acquisition of Solana (“SOL”) tokens as part of its digital asset treasury strategy [...]
European Medicines Agency Recommends Marketing Authorization of AVT03, Alvotech’s Proposed Biosimilar to Prolia® and Xgeva®
22/09/2025
REYKJAVIK, Iceland, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced [...]
European Medicines Agency Recommends Marketing Authorization of AVT03, Alvotech’s Proposed Biosimilar to Prolia® and Xgeva®
22/09/2025
REYKJAVIK, ICELAND (September 22, 2024) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the [...]
First European Participants Randomized in AskBio Phase 2 Gene Therapy Trial of AB-1005 for Parkinson’s Disease
22/09/2025
Research Triangle Park, N.C., Sept. 22, 2025 (GLOBE NEWSWIRE) -- AB-1005, a glial cell line-derived neurotrophic factor (GDNF) investigational gene therapy, is being evaluated for the treatment of moderate-stage [...]
Helio Diagnostics: A European CDMO dedicated to In Vitro Diagnostics
22/09/2025
Helio Diagnostics: A European CDMO dedicated to In Vitro Diagnostics Helio Diagnostics is backed by a team with 25+ years of experience in the development and manufacturing of complex diagnostic devices. Marseille, [...]
European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner
22/09/2025
REYKJAVIK, ICELAND and LONDON, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and [...]
European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner
22/09/2025
REYKJAVIK, ICELAND and LONDON, UK (September 22, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma [...]
Oculis Announces Presentation of Phase 2 ACUITY trial results with Privosegtor in Acute Optic Neuritis at ECTRIMS
22/09/2025
ZUG, Switzerland, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Privosegtor ACUITY Trial showed Improved LCVA and preservation of Ganglion Cells in Acute Optic Neuritis. Results from a Multicenter Randomized Placebo-Controlled [...]
Oculis Announces Presentation of Phase 2 ACUITY trial results with Privosegtor in Acute Optic Neuritis at ECTRIMS
22/09/2025
Privosegtor ACUITY Trial showed Improved LCVA and preservation of Ganglion Cells in Acute Optic Neuritis. Results from a Multicenter Randomized Placebo-Controlled Double-Masked Trial ZUG, Switzerland, Sept. 22, 2025 ( [...]
BetaGlue Therapeutics Announces the Appointment of Alexis Peyroles as New Chief Executive Officer
22/09/2025
MILAN, Sept. 22, 2025 (GLOBE NEWSWIRE) -- BetaGlue ® Therapeutics (“BetaGlue” or the “Company”) a clinical-stage oncology company developing an innovative radiotherapy platform for the targeted and personalised [...]

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