fda-and-biotech News
BridgeBio Soars to 52-Week High on Positive Drug Trial Results
Phase 3 study for its rare calcium disorder drug, Encaleret, met all primary and secondary endpoints, prompting a surge in the company's shares.
BioMarin Shares Slump as Analysts Cut Targets on Strategic Pivot
Company to divest Roctavian gene therapy after weak sales, raising concerns over its long-term growth strategy and competition for its key drug, Voxzogo.
Rani Therapeutics Director Buys $1.3M Stake Amid 500% Stock Surge
Executive Chairman's purchase is part of a larger $60.3M private placement following a landmark collaboration deal with Chugai Pharmaceutical.
Edwards Lifesciences Stock Jumps 7% on Positive Heart Valve Data
Successful one-year results for the SAPIEN M3 and EVOQUE systems, presented at a major cardiology conference, reinforce the company's market leadership.
Incyte Shares Rise on Positive Phase 3b Data for Eczema Cream Opzelura
The study met all primary endpoints, showing significant improvement in moderate atopic dermatitis and paving the way for a European regulatory submission.
Vivani Medical Shares Fall After Announcing $15.7M Stock Offering
The capital raise, priced at $1.62 per share, is set to fund key clinical trials for its diabetes and obesity drug candidates but creates significant shareholder dilution.
Castle Biosciences Gains on New Esophagus Test Data
Data from a major gastroenterology conference shows the TissueCypher test helps clinicians manage precancerous conditions, boosting confidence in a key growth driver.
Fate Therapeutics Surges 8% on Promising Lupus Therapy Data
Company's off-the-shelf CAR T-cell therapy, FT819, shows durable responses and immune remodeling in patients with severe autoimmune disease.