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Ziihera FDA approval unlocks $250m for Zymeworks as Jazz expands HER2 drug into first-line gastric cancer
The FDA has approved two Ziihera-based first-line regimens for HER2-positive advanced gastroesophageal adenocarcinoma, triggering a $250 million payment to Zymeworks and giving Jazz a much larger commercial opportunity.
Gossamer Bio (Nasdaq: GOSS) secures regulatory-linked funding as seralutinib NDA nears September
The financing can reach US$250 million, but only about US$25 million is scheduled at the initial closing; another US$125 million requires FDA acceptance of the NDA and US$100 million depends on approval-linked warrants.
Milestone takes etripamil into Phase 3 AFib test with at-home treatment strategy
Milestone Pharmaceuticals has dosed the first patient in a pivotal Phase 3 trial testing whether etripamil nasal spray can give patients with rapid-rate atrial fibrillation an at-home alternative to emergency treatment.
Amylyx Phase 3 win sends AMLX soaring as avexitide cuts hypoglycemia events 55%
Amylyx Pharmaceuticals’ avexitide reduced clinically significant hypoglycemic events by 55% in the pivotal LUCIDITY trial, putting the company on track for an FDA filing by year-end and triggering a sharp re-rating in AMLX shares.
Ultragenyx (Nasdaq: RARE) wins FDA approval for $2.7m Genglycos gene therapy
Genglycos becomes the first approved treatment for glycogen storage disease type Ia, but accelerated approval rests on reduced cornstarch use as a surrogate endpoint and requires confirmatory evidence.
Shield Therapeutics (AIM: STX) cuts H1 loss 76% as revenue rises 42% to $30.4m
Group revenue reached US$30.4 million and the loss narrowed to US$2.3 million, but Accrufer prescription growth of 21% translated into only 5% US product-revenue growth as net pricing weakened.
Can neridronate justify a $500m Ambros valuation after earlier Phase 3 setbacks?
Werewolf stock surges as a $150m Ambros merger funds neridronate through its pivotal 2028 CRPS-1 trial and planned FDA filing.
Three-year survival hits 83% as Johnson & Johnson expands TECVAYLI into second-line myeloma
TECVAYLI moves into earlier EU myeloma care after cutting progression risk 83.4%, strengthening Johnson & Johnson’s fast-growing oncology franchise.
Scholar Rock keeps apitegromab FDA decision alive as Europe filing is reset
Scholar Rock has removed Catalent Indiana from the U.S. apitegromab application while keeping its September 30 FDA decision date intact, but the manufacturing issue has forced a European filing withdrawal and resubmission.
LEO Pharma bets up to $435m on dersimelagon as rare skin drug nears FDA decision
LEO Pharma will pay up to $435 million in upfront and near-term milestones for global rights to dersimelagon, a Phase 3 rare-disease drug already submitted to the FDA.