fda-and-biotech News
Pharvaris Shares Surge on Positive HAE Drug Trial Results
Pivotal Phase 3 study for its oral drug deucrictibant met all primary and secondary endpoints, setting the stage for regulatory submissions in 2026.
Biogen Shares Climb on New LEQEMBI Alzheimer's Data
Data from the CTAD 2025 conference confirms the drug's direct impact on neurotoxic proteins, bolstering confidence in its mechanism of action amid fierce market competition.
AstraZeneca Gains on FDA Fast Track for Hypertension Drug
The FDA's Priority Review for baxdrostat, a potential first-in-class therapy, could accelerate its path to a market with significant unmet medical need.
SeaStar Medical Surges on FDA Decision to Cut Study Size
Regulator's approval to reduce post-market trial enrollment for QUELIMMUNE device by 83% significantly cuts costs and de-risks commercial path for the biotech firm.
Kura Oncology Surges After $135M Milestone from Cancer Drug Launch
First U.S. commercial sale of leukemia therapy KOMZIFTI triggers significant non-dilutive payment from partner Kyowa Kirin, bolstering the company's financial position.
BioNexus Gene Lab Secures $500M Facility, Spurring Dilution Fears
The financing deal, over 60 times the biotech firm's market capitalization, raises significant concerns for shareholder value despite funding growth plans.
Sangamo Climbs on FDA Fast Track for Non-Opioid Pain Drug
The biotech firm gains momentum with a second positive regulatory update in as many weeks, accelerating the timeline for its chronic pain therapy.
Belite Bio Shares Pull Back After $350 Million Stock Offering
Company capitalizes on record-high share price to fund late-stage development of its lead ophthalmology drug, Tinlarebant, causing near-term dilution.