Helius Medical ($HSDT) PoNS Trial Shows Promise for Stroke Gait Deficits

Helius Medical Technologies, Inc. (HSDT) announced a positive outcome from the PoNS Stroke Registrational Program supporting a planned FDA submission seeking an indication for...

Telomir Pharmaceuticals, Inc. ($TELO) Highlights Telomir-1’s Superior Efficacy Over Standard Cancer Drugs

Telomir Pharmaceuticals, Inc. (TELO) revealed groundbreaking preclinical results demonstrating Telomir-1’s power to reverse epigenetic gene silencing in aggressive human prostate cancer cells, outperforming Paclitaxel...

Viatris Inc. ($VTRS) Announces Phase 3 Blepharitis Study Misses Key Goal

Viatris Inc. (VTRS) reported that its Phase 3 study evaluating pimecrolimus 0.3% ophthalmic ointment for blepharitis did not achieve the primary endpoint of complete...

U.S. Patent Awarded to Nuwellis, Inc. ($NUWE) for Extracorporeal Device

Nuwellis, Inc. (NUWE) has secured U.S. Patent No. 12,357,734 for its “Extracorporeal Blood Filtering Machine and Methods,” officially granted on July 15, 2025, enhancing...

Celcuity Inc. ($CELC) Gains Patent Protection for Breast Cancer Drug Gedatolisib

Celcuity Inc. (CELC) has secured U.S. Patent No. 12,350,276, protecting the clinical dosing regimen of its lead drug candidate, gedatolisib, for ER+/HER2- breast cancer...

Milestone Pharmaceuticals Inc. ($MIST) Advances CARDAMYST™ Nasal Spray FDA Review

Milestone® Pharmaceuticals Inc. (MIST) announced that the FDA has accepted for review the company’s response to the Complete Response Letter for CARDAMYST™ (etripamil) nasal...

Cogent Biosciences ($COGT) Achieves Significant Improvement in Mastocytosis Study

Cogent Biosciences, Inc. (COGT) announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with non-advanced...

FDA Approves EKTERLY by KalVista ($KALV) as First Oral On-Demand HAE Treatment

KalVista Pharmaceuticals, Inc. (KALV) announced FDA approval of EKTERLY, a novel plasma kallikrein inhibitor, for treating acute hereditary angioedema attacks in patients aged 12...

APGE’s APG777 Shows Promise in Treating Moderate-to-Severe Atopic Dermatitis

Apogee Therapeutics, Inc. (APGE) announced positive 16-week data from Part A of the Phase 2 APEX clinical trial of APG777, a potential best-in-class anti-IL-13...

Regeneron Pharmaceuticals, Inc. ($REGN) Secures FDA Nod for Lynozyfic™ Targeting Relapsed Multiple Myeloma

Regeneron Pharmaceuticals, Inc. (REGN) announced that the U.S. Food and Drug Administration has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with...

Catalyst News