fda-and-biotech News
Kura Oncology Tumbles on Weak Debut Sales for Cancer Drug KOMZIFTI
The biotech's initial $2.1M revenue for its new leukemia drug falls dramatically short of $46.3M consensus, raising concerns over its commercial launch.
Cell and Gene Therapy Stocks Rally on FDA Regulatory Easing
The agency's move to increase flexibility for development requirements is seen as a major boost for the innovative but costly biotech sector.
Zymeworks Drug Zanidatamab Shows Major Survival Benefit in Stomach Cancer
Positive Phase 3 data for its HER2-targeted therapy, developed with partner Jazz Pharmaceuticals, positions it as a potential new standard of care in gastroesophageal adenocarcinoma.
Corcept Stock Rebounds Sharply After FDA Setback for Relacorilant
Investors look past the regulator's rejection for a hypertension indication, focusing on the drug's larger potential in ovarian cancer.
Mesoblast Surges to 52-Week High on Strong Ryoncil Sales
The biotech firm reported a 60% year-over-year increase in December quarter sales for its flagship therapy, fueling investor optimism.
ARS Pharma Stock Surges as Rival's Allergy Drug Hits FDA Snag
An FDA letter citing deficiencies in Aquestive Therapeutics' application for a competing epinephrine product is clearing the path for ARS Pharma's needle-free treatment, 'neffy'.
Bright Minds Stock Pressured by $175M Public Offering
The clinical-stage biotech raised capital to fund its pipeline, but the move introduces significant share dilution for existing investors, creating headwinds for the stock.
Eli Lilly Surges as Zepbound Shows Promise in Arthritis Treatment
Phase 3 trial data suggests the blockbuster weight-loss drug, when combined with Taltz, improves psoriatic arthritis and aids weight loss, signaling a significant market expansion.