fda-and-biotech News
Cogent Bio Shares Double on Landmark Cancer Drug Trial Success
Phase 3 results for its GIST therapy bezuclastinib show a significant leap in effectiveness, positioning it as a potential new standard of care.
MeiraGTx Shares Surge on Gene Therapy Pact with Eli Lilly
The strategic collaboration includes a $75 million upfront payment and over $400 million in potential milestones to develop treatments for inherited blindness.
uniQure Shares Plummet Over 60% After FDA Reverses Stance on Gene Therapy
Regulator's unexpected shift on data requirements for Huntington's disease drug AMT-130 creates significant uncertainty for approval pathway.
AstraZeneca Hypertension Drug Succeeds in Late-Stage Trial
Baxdrostat, acquired in the $1.8B CinCor deal, shows significant blood pressure reduction, paving the way for regulatory submission.
Intellia Stock Plummets 22% Despite Positive HAE Drug Data
Stellar results for the company's hereditary angioedema therapy were completely overshadowed by an FDA clinical hold on a separate, more advanced drug program.
Regeneron shares climb on promising anti-clotting drug data
Positive Phase 2 results for two Factor XI antibodies position the biotech firm as a strong contender in the safer anticoagulants race, a market plagued by bleeding risks.
BridgeBio Soars on Landmark Heart Drug Trial Results
Acoramidis shows a 59% reduction in mortality for a rare heart disease, positioning it as a major challenger in a multi-billion dollar market.
CRISPR Soars on Landmark Gene-Editing Data for Heart Disease
Phase 1 trial for CTX310 shows a single dose can slash cholesterol and triglyceride levels, signaling a potential one-time cure for lipid disorders.