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Press releases published on September 18, 2025
Plus Therapeutics Announces Successful Accreditation and Certification for Its CNSide® Diagnostics Clinical Laboratory
Certification critical to broad U.S. market release of the CNSide CSF Assay Platform CNSide now meets key federal and state regulatory requirements, including those set by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Lab …
Intellia Therapeutics Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema
Completed patient enrollment within nine months with nearly half enrolled from the U.S. Expect to report Phase 3 topline data in the first half of 2026 On track to submit BLA in the second half of 2026 for an anticipated U.S. launch in the first half of …
Zevra Therapeutics Announces Upcoming Oral Presentation at the International Niemann-Pick Disease Alliance (INPDA) Meeting and Poster Presentations at the Child Neurology Society (CNS) Conference on MIPLYFFA® (arimoclomol) and OLPRUVA® (sodium…
MIPLYFFA, the only therapy for Niemann-Pick disease type C (NPC) shown to stop disease progression at 12 months, has been administered to more than 270 patients, representing the largest data set of NPC clinical trial patients OLPRUVA offers the …
Minovia Therapeutics Receives FDA Fast Track Designation for MNV-201 in Myelodysplastic Syndrome
HAIFA, Israel, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical-stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age-related decline, announces that the U …
Cytokinetics Announces Three Upcoming Presentations at the HFSA Annual Scientific Meeting 2025
Long-Term Data from FOREST-HCM in Non-Obstructive HCM and Results from Prespecified Analysis of MAPLE-HCM to be Presented in Late-Breaking Clinical Research Session SOUTH SAN FRANCISCO, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated …
MiNK Therapeutics Appoints Dr. Terese C. Hammond to Accelerate iNKT Pipeline to Pivotal Development
Imminent launch of grant-funded clinical trial in graft-versus-host disease (GVHD) Advancing clinical program in severe pulmonary inflammatory disease NEW YORK, Sept. 18, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (Nasdaq: INKT), a clinical-stage …
Minovia Therapeutics קיבלה את אישור המסלול המהיר של ה-FDA עבור MNV-201 בתסמונת מיאלודיספלסטית
חיפה, ישראל, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Minovia Therapeutics Ltd("מינוביה" או "החברה"), חברת ביוטכנולוגיה בשלבים קליניים המפתחת טיפולים חדשניים לטיפול במחלות מיטוכונדריאליות ולמאבק בהידרדרות הקשורה לגיל, מודיעה כי מינהל המזון והתרופות האמריקני ( …
Cullgen Completes Enrollment in Phase 1 Trial of its Novel Non-Opioid Pain Product Candidate CG001419
SAN DIEGO, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Cullgen Inc. (“Cullgen”), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies, today announced the completion of enrollment …
BioXcel Therapeutics Regains Compliance with Nasdaq Market Value of Listed Securities Requirements
NEW HAVEN, Conn., Sept. 18, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it has received written …
Humacyte Announces Publication of Preclinical Data on Use of the CTEV as a Coronary Artery Bypass Graft (CABG)
- Results were published in JACC: Basic to Translational Science - - Publication evaluated coronary tissue engineered vessel (CTEV) as a conduit for CABG in a nonhuman primate model - - All implanted CTEVs remained patent through six months, demonstrated …
BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Top Line Data of Roll-in Cohort Show Improved Exercise Tolerance and Reduced Angina Episodes at Six-Month Primary Follow-up
SUNNYVALE, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the primary endpoint results of the open …
KFSHRC to Participate in C3 Davos of Healthcare™ Japan Summit
TOKYO, Sept. 18, 2025 (GLOBE NEWSWIRE) -- King Faisal Specialist Hospital and Research Centre (KFSHRC) has announced its participation in the C3 Davos of Healthcare™ Japan Summit, taking place on September 24, 2025 under the theme “A Tri-Nation …
Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Ireland
STAFFORD, Texas, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy …
Epitopea Strengthens Scientific Advisory Board with Appointment of Four World Renowned Experts in Cancer Immunology and Immunotherapy
CAMBRIDGE, United Kingdom and MONTREAL, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Epitopea, a transatlantic cancer immunotherapeutics company developing accessible, off-the-shelf RNA-based immunotherapies, today announced the appointment of four world leading …
Epitopea renforce son comité consultatif scientifique avec la nomination de quatre experts de renommée mondiale en immunologie et immunothérapie du cancer
CAMBRIDGE, ROYAUME-UNI et MONTRÉAL, 18 sept. 2025 (GLOBE NEWSWIRE) -- Epitopea, une société transatlantique spécialisée dans l'immunothérapie anticancéreuse qui développe des immunothérapies accessibles et prêtes à l'emploi à base d'ARN, a annoncé aujourd' …
Imprivata, éditeur international de solutions de gestion des accès, se développe sur le marché français pour répondre à la demande croissante en matière de sécurité et de conformité
Initialement axées sur les soins de santé, les solutions Imprivata permettent un accès clinique rapide et sécurisé aux services informatiques afin de soutenir le programme CaRE et en particulier le domaine HospiConnect. LONDRES, 18 sept. 2025 (GLOBE …
Concurrent Publications in Nature and Nature Medicine Highlight Advances in Blood Pressure Regulation after Spinal Cord Injury Using ONWARD ARC-IM Therapy
Detailed results from clinical feasibility studies show immediate improvement in blood pressure stability and durable reduction of hypotensive symptoms, resulting in improved quality of life Most people living with spinal cord injury experience blood …
89bio, Inc. Announces Agreement to be Acquired by Roche
– 89bio stockholders to receive up to $20.50 per share in cash, comprised of $14.50 per share in cash at closing and a non-tradeable contingent value right (CVR) to receive up to an aggregate of $6.00 per share in cash; transaction represents total equity …
Fangzhou Named ‘Outstanding Growth Story in Hong Kong Stocks’ at China Capital Market Development Forum 2025
SHANGHAI, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Fangzhou Inc. ("Fangzhou" or the "Company") (06086.HK), a leader in AI-driven Internet healthcare solutions, was recognized as an “Outstanding Growth Story in Hong Kong Stocks” at the China Capital Market …