fda-and-biotech News
Amylyx Surges 16% on New Pipeline Drug, CEO Option Exercise
Shares rally as company unveils new candidate for hypoglycemia, building a franchise beyond its past ALS drug setback and signaling a strategic pivot.
enGene Secures $125M Debt Facility to Advance Gene Therapy Pipeline
Financing from Hercules Capital provides non-dilutive capital to extend the clinical-stage biotech's operational runway as it develops its novel genetic medicines.
Mesoblast Surges After FDA Signals Clear Path for Back Pain Drug
Regulator acknowledges efficacy of rexlemestrocel-L and opens door to a coveted opioid-sparing label, boosting prospects in a multi-billion dollar market.
Tiziana Life Sciences Soars as $8.8M Funding Eclipses Dilution Fears
Shares jumped over 13% as strong insider participation in the capital raise signals confidence in the company's clinical pipeline, outweighing shareholder dilution concerns.
Telix Advances Key Prostate Cancer Diagnostic to Phase 3 in U.S.
Company doses first American patient in its BiPASS study, a pivotal trial aimed at improving diagnostic accuracy and reducing unnecessary biopsies.
Teva Shares Climb on Positive AJOVY Data in Prominent Medical Journal
Publication in the New England Journal of Medicine reinforces the migraine drug's clinical profile, bolstering its position in a competitive market.
Scienture Secures Key Patent for High-Dose Opioid Overdose Spray
New Orange Book-listable patent for REZENOPY™ provides long-term market protection as the company targets the $154 million naloxone market.
TG Therapeutics Boosts 2026 Revenue Forecast on Briumvi Strength
Shares climb as the company reports strong preliminary 2025 sales for its multiple sclerosis drug and raises full-year guidance, signaling confidence in its growth trajectory.