fda-and-biotech News
TG Therapeutics Boosts 2026 Revenue Forecast on Briumvi Strength
Shares climb as the company reports strong preliminary 2025 sales for its multiple sclerosis drug and raises full-year guidance, signaling confidence in its growth trajectory.
Crinetics Soars as New Acromegaly Drug Smashes Sales Forecasts
Oral drug PALSONIFY generates over $5 million in its first quarter, more than doubling analyst estimates and signaling a major shift in treatment for the rare disease.
Travere Shares Dive 18% as FDA Delays Key Kidney Drug Decision
Regulator extends review for Filspari, the first potential treatment for rare kidney disorder FSGS, creating uncertainty for the biopharma firm.
XTL Biopharma Surges 26% on Deal to Enter Autism Market
Micro-cap shifts strategy with acquisition of NeuroNOS, adding two Nobel Prize-winning scientists to its advisory team in a pivot to neuroscience.
Coherus Stock Slides on Revenue Miss, Testing Faith in Oncology Pivot
Preliminary Q4 revenue falls short of estimates, but firm projects strong growth for its key cancer drug LOQTORZI and confirms cash runway through 2026.
Moleculin Skyrockets as Cancer Drug Shows No Heart Toxicity
Shares surged nearly 900% after an independent review of its lead drug Annamycin, a next-generation anthracycline, found no evidence of cardiotoxicity in 90 trial subjects.
Argenx Gains on FDA Priority Review for Vyvgart Label Expansion
The agency will expedite the review of the company's flagship drug for a new subgroup of myasthenia gravis patients, a key step in expanding its market reach.
Sarepta Stock Plunges as Elevidys Sales Fall Short
Shares tumbled nearly 12% after initial revenue from the company's cornerstone gene therapy for Duchenne muscular dystrophy disappointed investors.