COMMUNIQUÉS West-GlobeNewswire

Erasca Granted FDA Fast Track Designation for Pan-RAS Molecular Glue ERAS-0015 in Patients with Metastatic Pancreatic Adenocarcinoma
24/08/2026
Designation follows encouraging Phase 1 activity across multiple tumor types including 2L+ KRAS G12X pancreatic cancer Three potentially registration-enabling trials planned across pancreatic and lung cancers Additional [...]
AEON Biopharma Designates Former FDA Neuroscience Leader Paul Lee, M.D., Ph.D. as Acting Chief Regulatory Officer
24/08/2026
- Former Deputy Director of the FDA’s Office of Neuroscience - Dr. Lee has previously advised AEON through Clintrex Research LLC (Clintrex), an affiliate of BlueRidge Life Sciences, on the regulatory strategy for ABP- [...]
ADARx Pharmaceuticals Receives FDA Fast Track Designation for Onvuzosiran for the Treatment of HAE
24/08/2026
SAN DIEGO, Aug. 24, 2026 (GLOBE NEWSWIRE) -- ADARx Pharmaceuticals, Inc. (ADARx), a late-stage clinical biotechnology company developing next-generation siRNA therapeutics, announced today that it has received Fast [...]
Bionano to Participate in the H.C. Wainwright 28th Annual Global Investment Conference
24/08/2026
SAN DIEGO, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced that management will present and host 1x1 meetings at the H.C. Wainwright 28th Annual Global Investment Conference on [...]
Liminatus Pharma Engages Synex as Contract Research Organization to Support Phase 1/2a Clinical Development of CD19xCD22 bivalent CAR-T therapy
24/08/2026
Engagement advances clinical execution of IBC101, Liminatus’ CD19xCD22 bivalent CAR-T therapy for relapsed or refractory B-cell malignancies FULLERTON, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- Liminatus Pharma, Inc. ( [...]
Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions
24/08/2026
– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 – – Supplemental BLA will be supported by results from three Phase 3 studies of ATEV, [...]
Elicio Therapeutics to Participate at the Wells Fargo 21st Annual Healthcare Conference
24/08/2026
BOSTON, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, [...]
Rhythm Pharmaceuticals Announces MHLW Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity (HO) in Japan
24/08/2026
-- Approximately 5,000 to 8,000 patients estimated to be living with acquired HO in Japan -- -- Commercial launch in Japan expected by end of 2026, pending final pricing determination -- BOSTON, Aug. 24, 2026 (GLOBE [...]
Clearmind Advances MDMA-N-acylethanolamines IP for the Treatment of PTSD Amid Rising U.S. Federal Support for Psychedelic Innovation
24/08/2026
U.S. publication of the patent application covering the MDMA-N-acylethanolamines combination expands intellectual property generated through the collaboration with Neurothera Labs Inc. as the FDA introduces a dedicated [...]
LEQEMBI IQLIK® (lecanemab-irmb) Autoinjector for Initiation of Therapy Now Available in the U.S. for Early Alzheimer’s Disease
24/08/2026
LEQEMBI IQLIK is the first-of-its-kind anti-amyloid treatment worldwide offering at-home dosing for initiation and maintenance (approved in the U.S.) TOKYO and CAMBRIDGE, Mass., Aug. 24, 2026 (GLOBE NEWSWIRE) -- Eisai [...]
New Analyses from REDUCE-IT® and EPA Mechanistic Data to be Presented at the European Society of Cardiology (ESC) Congress 2026
24/08/2026
DUBLIN and BRIDGEWATER, N.J., Aug. 24, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a company committed to advancing the science of cardiovascular disease worldwide, today announced upcoming [...]
BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval
24/08/2026
SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- BioCardia ® , Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today [...]
CVRx Announces Devoted Health Medicare Advantage Coverage Policy for Barostim Therapy
24/08/2026
MINNEAPOLIS, Aug. 24, 2026 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions [...]
Alkeus Pharmaceuticals Announces Japan Ministry of Health, Labour and Welfare (MHLW) Has Granted Orphan Drug Designation to Gildeuretinol for Stargardt Disease
24/08/2026
CAMBRIDGE, Mass., Aug. 24, 2026 (GLOBE NEWSWIRE) -- Alkeus Pharmaceuticals, Inc., a biopharmaceutical company dedicated to preserving the sight of individuals impacted by retinal diseases, today announced that the [...]
Lexicon Pharmaceuticals Earns Third $10 Million Milestone Payment from Novo Nordisk Following Achievement of Key Phase 1 Development Milestone for LX9851
24/08/2026
LX9851 is a first-in-class, oral non-incretin candidate being developed by Novo Nordisk for the treatment of obesity and associated metabolic disorders Lexicon is eligible to receive up to $1 billion in total upfront [...]
SciSparc: NeuroThera-Clearmind Collaboration Advances MDMA-N-acylethanolamines IP for the Treatment of PTSD Amid Rising U.S. Federal Support for Psychedelic Innovation
24/08/2026
U.S. publication of a patent application covering the MDMA-N-acylethanolamines combination expands intellectual property generated through the collaboration, and provides guidance addressing clinical development [...]
Starling Oncology to Participate in Wells Fargo Healthcare Conference
24/08/2026
CERRITOS, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- Starling Oncology™, Inc. (NASDAQ: STLN), (“STLN” or the “Company”), one of the largest value-based community oncology groups in the United States, today announced that [...]
GRI Bio to Present Late-Breaking Phase 2a GRI-0621 Data Highlighting Lung Function, Anti-Fibrotic Biomarkers and Favorable Tolerability in IPF at ERS 2026
24/08/2026
LA JOLLA, CA, Aug. 24, 2026 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company developing innovative therapies for inflammatory, fibrotic and autoimmune diseases, today [...]
Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA
24/08/2026
– New PDUFA target action date of November 22, 2026 follows submission of additional Phase 3 HOPE-3 data and analyses supporting a refined proposed indication – SAN DIEGO, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Capricor [...]

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