fda-and-biotech News
Outlook Therapeutics Falls as FDA Decision Looms Over Mounting Losses
The company reported its first-ever annual revenue but a net loss of $62.4 million, with its future hinged on a year-end FDA ruling for its lead eye drug after two prior rejections.
Takeda Stock Gains on Promising Phase 3 Psoriasis Drug Data
Oral medication zasocitinib proved superior to Amgen's Otezla, positioning Takeda to challenge Bristol Myers Squibb in the lucrative TYK2 inhibitor market.
BeOne Medicines Jumps on FDA Fast Track for Liver Cancer Drug
The investigational drug BGB-B2033, a promising bispecific antibody, gains an expedited path for development in treating hepatocellular carcinoma, a common form of liver cancer.
Galapagos Weighs Options as Key Drug Yields Mixed Trial Results
TYK2 inhibitor succeeds in study for rare muscle disease dermatomyositis but falls short in lupus trial, prompting a strategic review and search for partners.
Athira Stock Soars 72% on Transformative Cancer Drug Bet
The company secures a $90 million financing to license late-stage breast cancer drug lasofoxifene, pivoting from its challenging Alzheimer's pipeline.
Sangamo Stock Gains on FDA Submission for Fabry Disease Gene Therapy
The biotech company has initiated a rolling Biologics License Application for ST-920, a potential one-time treatment for the rare genetic disorder, signaling a major regulatory milestone.
Athira Pharma Surges After Pivoting to $236M Cancer Drug Deal
Shares soar as company licenses late-stage breast cancer drug Lasofoxifene, securing major financing after its Alzheimer's candidate failed a key trial.
NRx Pharma Stock Jumps After Wiping Out All Balance Sheet Debt
The biotech firm converted its remaining $5.4 million in debt to equity, bolstering its financial standing ahead of key FDA decisions on its depression and PTSD drug candidates.