fda-and-biotech News
Shattuck Labs Surges After Analyst Upgrade on IBD Drug Confidence
HC Wainwright initiates a 'Buy' rating and a $6 price target, citing potential in the company's next-generation therapy for inflammatory bowel disease.
Belite Bio Soars on Landmark Stargardt Disease Trial Success
Company's stock rallies over 12% after its lead drug Tinlarebant meets the primary endpoint in a pivotal Phase 3 study; announces public offering to fund commercialization.
Amneal Wins FDA Nod for Generic Restasis, Eyes $2B Dry-Eye Market
The approval positions Amneal to compete in the lucrative market for cyclosporine eye drops, with a commercial launch planned for the first quarter of 2026.
Janux Shares Surge on Promising Prostate Cancer Drug Data
Early trial results for JANX007 show significant efficacy and a favorable safety profile in a difficult-to-treat form of metastatic prostate cancer, validating the company's core technology.
Neumora Shares Surge on Promising Obesity Drug Data
RBC Capital upgrades the neuroscience-focused company to Outperform, citing strong potential in its early-stage oral weight-loss candidate.
J&J Gains EU Approval for IMAAVY, Eyes Blockbuster Status
The European Commission has authorized Johnson & Johnson's nipocalimab for generalized myasthenia gravis, setting the stage for a new revenue driver.
MannKind Gains FDA Review for Faster Heart Failure Drug Delivery System
The regulator has set a July 26, 2026 target date for a decision on the FUROSCIX ReadyFlow autoinjector, a 10-second alternative to its current 5-hour infusion.
Akebia Buys Q32 Bio Drug to Forge Rare Kidney Disease Pipeline
Company to pay up to $600 million for Phase 2 asset, making a strategic pivot as its stock trades near a 52-week low.