FDA Accepts Revolution Medicines' Daraxonrasib NDA for Metastatic Pancreatic Cancer After Phase 3 Trial
Updated
Updated · Simply Wall St · Aug 2
FDA Accepts Revolution Medicines' Daraxonrasib NDA for Metastatic Pancreatic Cancer After Phase 3 Trial
3 articles · Updated · Simply Wall St · Aug 2
Summary
Revolution Medicines said the FDA accepted its New Drug Application for daraxonrasib in previously treated metastatic pancreatic ductal adenocarcinoma, a key regulatory step for the KRAS-targeted therapy.
Phase 3 RASolute 302 data supported the filing, with the company citing survival and quality-of-life results in a cancer with high unmet need.
Shares closed at $187.53; the stock has gained 34.45% in 90 days, 137.32% year to date and more than 400% over one year as investors price in regulatory progress.
The company’s broader RAS(ON) pipeline includes eight ongoing or planned Phase III registrational trials and clinical experience in more than 2,500 patients, but the story still hinges on cash burn and trial execution.
Daraxonrasib doubled pancreatic cancer survival, but could regulatory delays or astronomical cash burn derail this biotech darling's massive stock surge?
As FDA review begins, will this breakthrough targeted therapy finally conquer one of the deadliest and most notoriously untreatable cancers?