Revolution Medicines shares climbed sharply, rising 33% on Monday after the company disclosed positive topline findings from the Phase 3 RASolute 302 trial of daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma who had received prior treatment.
The company reported that the trial met all primary and key secondary endpoints, specifically naming progression-free survival and overall survival among those measures. Daraxonrasib produced a median overall survival of 13.2 months, compared with 6.7 months for chemotherapy, and the reported hazard ratio was 0.40.
Following these results, Revolution Medicines said it plans to submit the data to regulatory authorities around the world. That submission strategy includes filing with the U.S. Food and Drug Administration as part of a future New Drug Application, using a Commissioner’s National Priority Voucher. The company also indicated the RASolute 302 data will be presented at the 2026 American Society of Clinical Oncology Annual Meeting.
Daraxonrasib is described by the company as a multi-selective inhibitor of RAS(ON) proteins, a design intended to target oncogenic RAS drivers. The company highlighted that pancreatic cancer is particularly dependent on RAS signaling - noting that more than 90% of pancreatic cancer patients have tumors driven by mutations in RAS proteins.
The RASolute 302 study enrolled patients whose pancreatic tumors included a broad array of RAS variants as well as patients without an identified RAS mutation. The trial specified primary endpoints of progression-free survival and overall survival in the subgroup of patients whose tumors harbor RAS G12 mutations. Secondary endpoints measured progression-free survival and overall survival across the entire enrolled population.
Revolution Medicines said results from the first interim analysis render all progression-free survival and overall survival endpoint results final. The company did not provide additional subgroup breakdowns or further detailed data in its topline release.
The market reaction to the topline announcement was immediate and pronounced, with the company's shares rising by a third on the day the results were disclosed.
Context and next steps
The company intends to move forward with regulatory filings and to present the data at a major oncology conference in 2026. Beyond the topline figures provided, additional data disclosures and regulatory interactions will determine the timing and scope of any approval processes.