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Press releases published on September 18, 2025
NeurAxis to Participate in the Lytham Partners Fall 2025 Investor Conference on September 30, 2025
CARMEL, Ind., Sept. 18, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and …
Gain Therapeutics Begins Its GT-02287 Phase 1b Extension Study in People with Parkinson’s Disease
Extension of the Phase 1b study will allow participants to continue dosing with GT-02287 for an additional nine months after completing the first 90-day dosing schedule The Phase 1b study enrolled 21 subjects and the last participants will complete 90 days …
Biogen to Acquire Alcyone Therapeutics, Expanding Drug Delivery Solution Portfolio for Key Product and Pipeline Candidates
Biogen to drive end-to-end development and commercialization of ThecaFlex DRx™, an investigational implantable device for intrathecal delivery of antisense oligonucleotides (ASOs) ThecaFlex DRx™ has the potential to be a new, convenient way to administer …
Aveanna Healthcare Announces Successful Debt Refinancing
ATLANTA, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Aveanna Healthcare Holdings Inc. (“Aveanna”) (Nasdaq: AVAH) today announced the closing of its refinanced first lien credit facility. The refinanced credit facility provides for the refinancing of the $886.0 …
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' …