Clinical Research
Merck Makes Strong Case for Winrevair in Earlier-Stage Pulmonary Arterial Hypertension (PAH) Patients After Positive Phase 3 HYPERION Results
Winrevair; Merck; HYPERION study; PAH; sotatercept; clinical worsening; early disease; activin signaling; FDA approval; Phase 3 trial
Placebo Response Trips Up Harmony Biosciences’ Fragile X Drug in Late-Stage Phase 3 Trial
Harmony Biosciences; ZYN002; Fragile X syndrome; Phase 3 trial; placebo response; clinical trial failure; RECONNECT study; transdermal cannabidiol gel
Seres Therapeutics Cuts 25% of Workforce Following FDA Feedback on Microbiome Therapy Trial
Seres Therapeutics; layoffs; microbiome; FDA feedback; SER-155; phase 2 trial; workforce reduction; biopharma; clinical studies; cash runway
Neurocrine Biosciences Reports Positive Phase 2 Results for Osavampator in Major Depressive Disorder
Neurocrine Biosciences; osavampator; Phase 2 results; major depressive disorder; AMPA-PAM; SAVITRI study; clinical trial; adjunctive treatment; depression; safety profile
Roche’s Oral SERD Achieves Progression-Free Survival Milestone in Pivotal Breast Cancer Trial
Roche; oral SERD; giredestrant; progression-free survival; pivotal study; breast cancer; ER-positive; endocrine therapy; Phase III trial; advanced breast cancer
J&J Halts Phase 2a Rheumatoid Arthritis Program for Imaavy (Nipocalimab) after Lackluster Results
Johnson & Johnson; Imaavy; nipocalimab; rheumatoid arthritis; Phase 2a trial; DAISY study; clinical trial failure; anti-TNFα therapy; autoimmune diseases
FDA Rejects PTC’s Vatiquinone Application for Friedreich’s Ataxia, Requests Further Studies
FDA rejection; PTC Therapeutics; vatiquinone; Friedreich’s ataxia; complete response letter; drug efficacy; additional clinical studies
Praxis Seizure Drug Vormatrigine Shows Strong Efficacy in Phase 2 Trial
Praxis Precision Medicines; vormatrigine; epilepsy; seizures; RADIANT study; focal onset seizures; Phase 2 trial; sodium channel blocker
Praxis touts ‘best-in-disease’ epilepsy data, but shares dip
Praxis Precision Medicines; epilepsy; vormatrigine; RADIANT study; focal onset seizures; Phase 2 trial; seizure reduction; clinical trial; anti-seizure medication; stock market
Viome and Scripps Initiate AI-Powered At-Home RNA Test for Early Colon Cancer Risk Detection
Viome; Scripps Research; AI-powered diagnostics; RNA test; at-home colon cancer screening; colon polyps; clinical study; microbiome; early cancer detection