fda-and-biotech News
Enanta Shares Jump as Promising RSV Drug Data Overlooks Q4 Revenue Miss
Investors focus on positive clinical trial results for two RSV candidates and improved cost controls, shrugging off lower-than-expected royalty revenue.
Enanta Shares Surge as RSV Drug Hopes Outweigh Mixed Q4 Results
The biotech firm's stock jumped over 6% after it highlighted positive clinical data and a strong cash position, shifting focus from a slight revenue miss.
Annovis Bio Soars 33% on Promising Parkinson's Drug Data
Phase 3 trial shows buntanetap halts cognitive decline, with reversal in a key patient subgroup, boosting hopes for neurodegenerative disease treatment.
Nuvalent Shares Hit Record High on Promising Lung Cancer Drug Data
Neladalkib shows a 31% response rate in heavily pre-treated patients, carving out a potential niche in the competitive ALK-positive lung cancer market.
Zymeworks Stock Soars 30% on Positive Cancer Drug Trial Results
Phase 3 data for zanidatamab, partnered with Jazz Pharmaceuticals, shows significant improvement in treating gastroesophageal adenocarcinoma, paving way for regulatory submission.
Biohaven CEO, Director Make $5.5M Bet on Stock After FDA Setback
Coordinated insider purchase at 52-week low signals leadership conviction after regulatory rejection sent shares tumbling.
Sarepta Rallies Despite FDA 'Boxed Warning' on Gene Therapy
Investors focus on regulatory clarity and preserved market for Elevidys as shares climb over 5%, shrugging off severe liver injury risk.
IO Biotech Shares Plummet as Melanoma Vaccine Trial Narrowly Misses Goal
The company's lead candidate showed a 23% risk reduction in disease progression, but failed to meet the threshold for statistical significance, prompting the FDA to advise against seeking approval on current data.