fda-and-biotech News
Altimmune Stock Soars After FDA Breakthrough Tag for MASH Drug
Shares jumped over 15% after the U.S. regulator granted Breakthrough Therapy Designation to Pemvidutide, expediting the development path for the promising liver disease treatment.
Zenas BioPharma Stock Halved as Drug Trial Win Falls Short
Shares plunge over 56% as investors signal that positive data for its autoimmune drug obexelimab is not strong enough to challenge Amgen's rival treatment.
Crinetics Stock Soars 13% on Promising Adrenal Disorder Drug Data
Phase 2 results for atumelnant show significant hormone reduction and allow nearly 90% of patients to cut steroid dosage, a key goal in treating congenital adrenal hyperplasia.
GH Research Stock Soars 33% as FDA Lifts Hold on Depression Drug
The decision removes a two-year clinical hold on the company's lead candidate, GH001, clearing the path for pivotal Phase 3 trials in 2026.
Sanofi Gains FDA Priority Review for Expanded Use of Diabetes Drug Tzield
The U.S. regulator will fast-track the review of Tzield for use in young children, a key step in Sanofi's strategy to carve out a niche in the competitive diabetes market.
Verastem Halts Lung Cancer Trial, Pivots in Crowded Field
Shares slide as the biopharma firm reallocates resources from its KRAS G12C program to focus on more promising pancreatic and lung cancer candidates.
Outlook Therapeutics Stock Plummets After Third FDA Rejection of Eye Drug
Agency demands additional 'confirmatory evidence' for wet AMD drug Lytenava, placing the company's lead asset and financial future in jeopardy.
Outlook Therapeutics Stock Tumbles After FDA Rejects Key Eye Drug Again
The U.S. regulator has issued a second Complete Response Letter for the company's wet AMD treatment, ONS-5010, requesting additional efficacy data and clouding its U.S. market ambitions.