fda-and-biotech News
Biogen Gains as Alzheimer's Drug Leqembi Secures UK Approval
Regulators approve less-frequent maintenance dosing for Leqembi, bolstering its competitive stance against rivals in the growing Alzheimer's market.
AEON Biopharma Surges Despite 'Going Concern' Warning in Q3 Report
Investors focus on a strategic pivot to a biosimilar pathway for its migraine drug, ABP-450, overlooking stark financial disclosures.
CG Oncology Advances Bladder Cancer Therapy, Initiates FDA Submission
Company completes Phase 3 trial enrollment 10 months early and reports strong cash position, signaling a clear path to potential commercialization.
Galectin Focus Shifts to FDA Catalyst as Q3 Loss Widens
Investors look past earnings miss, focusing on upcoming regulatory feedback for its lead liver disease drug, belapectin, expected by year-end.
Sensei Bio Halts Cancer Drug, Explores Sale Amid Market Headwinds
Company to cut workforce by 65% and discontinue lead drug solnerstotug, citing difficult capital market conditions for the biotech sector.
Marker Therapeutics Shares Dip Despite Positive Lymphoma Drug Data
Company reports encouraging 66% response rate in its APOLLO study and beats Q3 earnings estimates, but fails to impress cautious investors.
Scholar Rock Advances Apitegromab with FDA After Setback
Company reports constructive FDA meeting for its lead SMA drug, signaling a clear path to a 2026 BLA resubmission despite recent manufacturing hurdles.
Verastem Oncology Tumbles After Pricing $90M Stock Offering
Shares fall as the biotech firm raises capital to fund the commercial launch of its newly approved cancer therapy, representing significant dilution for investors.