Revolution Medicines Awarded Voucher for Daraxonrasib (RMC-6236) Under FDA Commissioner’s National Priority Voucher Pilot Program
REDWOOD CITY, Calif., Oct. 16, 2025 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted a non-transferrable voucher for daraxonrasib (RMC-6236), the company’s RAS(ON) multi-selective inhibitor, under the Commissioner’s National Priority Voucher (CNPV) pilot program.
Daraxonrasib is being studied in two global Phase 3 clinical trials, RASolute 302 in patients with previously treated metastatic pancreatic ductal adenocarcinoma and RASolve 301 in patients with previously treated metastatic non-small cell lung cancer.
“We are honored to receive one of the first vouchers awarded under the Commissioner’s National Priority Voucher pilot program. As with the Breakthrough Therapy Designation daraxonrasib received earlier this year, we believe this voucher recognizes the large unmet need for new treatments for patients with RAS-addicted cancers and the potential of the investigational drug daraxonrasib to transform treatment for these diseases, including pancreatic cancer,” said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “With an expected data readout from RASolute 302 in 2026, we look forward to participating in the CNPV program and working with the FDA to bring daraxonrasib to patients.”
The FDA has designed the CNPV pilot program with the goal of accelerating the development and review of certain drugs and biological products that are aligned with U.S. national health priorities and enhancing the health interests of Americans.
The company is evaluating the impact of the voucher it received under the CNPV pilot program and is not adjusting any of its previously disclosed timelines at this time.
About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, are currently in clinical development. The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be its next RAS(ON) inhibitor to enter clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding: the company’s development opportunities, plans and timelines and its ability to build or advance its portfolio and R&D pipeline; the company’s expectations regarding timing of clinical trial initiation, enrollment and data readouts or disclosures; the potential for any of the company’s investigational products, including daraxonrasib, to become a standard of care; and the operations of CNPV pilot program and the impact of the company’s participation in this program. Forward-looking statements are typically, but not always, identified by the use of words such as “will,” “believe,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ current stage of development, the process of designing and conducting preclinical and clinical trials, risks that the results of prior clinical trials may not be predictive of future clinical trials, clinical efficacy, or other future results, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 6, 2025, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
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