fda-and-biotech News
Arcus Bio Shares Drop on Halt of Phase 3 Cancer Trial
Study of domvanalimab for upper GI cancer, conducted with partner Gilead, stopped for futility, prompting a strategic R&D shift.
Cytokinetics Gains on Key EU Panel Nod for Heart Drug Aficamten
A positive CHMP opinion for its hypertrophic cardiomyopathy drug was widely anticipated, as the market looks ahead to a crucial US FDA decision later this month.
ImmunityBio Jumps on EU Panel Nod for Bladder Cancer Drug
Anktiva's positive EMA recommendation for conditional approval paves the way for entry into the multi-million-dollar European market, building on its recent US FDA approval.
Tenaya Therapeutics Tumbles on Discounted $60M Stock Offering
Shares of the gene therapy developer fall sharply after it prices a capital raise at a discount, causing significant dilution for existing shareholders.
Innoviva Jumps as Landmark Gonorrhea Drug Data Published in The Lancet
Phase 3 trial validates zoliflodacin's efficacy against a top public health threat, with a critical FDA decision expected by December 15.
Mesoblast Surges on Positive Remestemcel-L Study Data
An independent study shows Mesoblast's lead drug candidate, Remestemcel-L, is superior to Ruxolitinib in treating SR-aGvHD.
Tenaya Soars on Trial Wins Before $75M Offering Halts Rally
FDA clears path for one gene therapy trial as another shows strong early data, but a planned capital raise tempers immediate investor enthusiasm.
Natera Surges as Study Shows Signatera Test Predicts Cancer Recurrence
Data from the Phase III PALLAS study shows the Signatera test is a powerful predictor of 5-year breast cancer recurrence, potentially expanding its use in patient monitoring.