Revolution Medicines (RVMD), a late-stage oncology company, saw its shares surge by more than 35% after the firm announced positive topline results from the Phase 3 RASolute 302 clinical trial evaluating Daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who had been previously treated. The trial met all primary and key secondary endpoints.
Following the news, RVMD is up 35.55%, up $130.71.
Company Profile
Revolution Medicines develops therapies for RAS-addicted cancers.
The firm's lead devlopment RAS(ON) inhibitors include Daraxonrasib (RMC-6236), Elironrasib G12C (RMC-6291) and Xoldonrasib G12D (RMC-9805).
Daraxonrasib is an investigational, oral RAS(ON) multi-selective, non-covalent inhibitor designed to target cancers, including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer.
Daraxonrasib is currently being evaluated in four global Phase 3 registrational trials, including three in PDAC and one in NSCLC.
Phase 3 RASolute 302 Trial Details
The Phase 3 RASolute 302 clinical trial is an ongoing, global, randomised Phase 3 registrational clinical trial designed to evaluate the efficacy and safety of daraxonrasib as a monotherapy in patients with previously treated PDAC.
The RASolute 302 trial enrolled patients with pancreatic tumours harbouring a wide range of RAS variants, as well as those without an identified RAS mutation.
The primary endpoints of the trial were PFS and OS in patients with tumours harbouring RAS G12 mutations.
Secondary endpoints assessed PFS and OS in all enrolled patients (the intent-to-treat population), including those with tumours with and without an identified RAS mutation.
Trial Key Findings
Daraxonrasib, taken orally once daily, demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with standard of care cytotoxic chemotherapy delivered intravenously.
In the overall study population, Daraxonrasib demonstrated a median OS of 13.2 months versus 6.7 months with chemotherapy, with a hazard ratio of 0.40.
Daraxonrasib was generally well tolerated, with a manageable safety profile and with no new safety signals.
What's Ahead For Daraxonrasib
The firm noted that Daraxonrasib was selected for the FDA Commissioner's National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.
Revolution Medicines intends to submit the data to global regulatory authorities, including the U.S. Food and Drug Administration, as part of a future New Drug Application.
Also, the firm anticipates presenting the data at the 2026 American Society of Clinical Oncology Annual Meeting.
RVMD has traded between $34.00 and $135.81 over the last year. The stock closed Friday's trade at $96.43.
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