fda-and-biotech News
Cartesian Therapeutics Climbs on FDA Nod for New Autoimmune Drug Trial
FDA accepts Investigational New Drug application for RNA cell therapy Descartes-08 in myositis, a key validation for the company's expanding pipeline.
uniQure Shares slide as FDA Meeting Signals Deep Regulatory Concerns
The gene therapy firm scheduled a 'Type A' meeting to discuss its Huntington's disease candidate, a formal step reserved for significant issues and potential clinical holds.
Enliven Therapeutics Stock Soars 50% on Promising Leukemia Drug Data
Early trial results for ELVN-001 show significant efficacy in heavily pre-treated Chronic Myeloid Leukemia patients, paving the way for a pivotal Phase 3 study.
MoonLake Surges Over 27% on Positive FDA Signal for Skin Drug
Regulator indicates a path for approval of Sonelokimab for hidradenitis suppurativa without new Phase 3 trials, a major boon for the biotech firm.
Invivyd Stock Gains on Strong Q4 Revenue, Positive Pipeline Update
Company reports preliminary PEMGARDA sales of $17.2 million, beating estimates, and initiates a key Phase 3 trial for its next-generation COVID-19 antibody.
Immuneering Stock Plunges 24% Despite 'Exceptional' Cancer Data
Investors sell off shares despite a reported doubling of survival rates in a pancreatic cancer trial, focusing on development timelines and competitive pressures.
Alumis Shares Face Pressure After Upsized Stock Offering
The biotech firm is raising capital to fund its clinical pipeline, a move that increases the share count and risks diluting existing shareholders.
Jazz Pharma Drug Sets Survival Record in Stomach Cancer Trial
Ziihera (zanidatamab) shows a 28% reduction in death risk, with median survival extending beyond two years, positioning it as a potential new standard of care.