EU Regulator Backs RASONQUE for Pancreatic Cancer, Opening Second Major Market
RVMD has more than doubled off its 52-week low of $47.45.
Summary
EMA's CHMP issued a positive opinion recommending EU approval of RASONQUE (daraxonrasib) for adults with previously treated metastatic pancreatic adenocarcinoma. A European Commission decision would grant centralized authorization across the EU/EEA, unlocking 30+ countries in one step. This follows the FDA's August 26 approval of the same drug in the same indication, which made it the first approved therapy of its kind in the US. The supporting Phase 3 data showed an overall survival hazard ratio of 0.40 and median OS of 13.2 months versus 6.7 months for comparators, a survival benefit that should support clinician uptake and payer negotiations. The company launched RASONQUE in the US at $39,800 per 30-day supply in late August and has since started dosing in the Phase 3 RASolute 309 trial. EU approval would add a second major revenue market to a company that reported a $644M Q2 net loss and drew $250M from its Royalty Pharma facility on October 13.
At the time of this announcement, RVMD was trading at $192.41 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $41.2B. The 52-week trading range was $47.45 to $224.31. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Wiseek News.