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Positive
- FDA awarded a CNPV voucher for daraxonrasib, potentially accelerating regulatory review.
- Daraxonrasib is currently under evaluation in two global Phase 3 trials, targeting significant unmet needs in PDAC and NSCLC.
- Expected RASolute 302 data readout in 2026 represents a key milestone for the program.
- Daraxonrasib previously received Breakthrough Therapy designation, underscoring its clinical potential.
Negative
- The non-transferrable nature of the voucher limits Revolution Medicines’ strategic flexibility regarding potential monetization or partnership opportunities.
- Daraxonrasib remains an investigational drug in Phase 3 trials, meaning regulatory approval is not guaranteed.
- The data readout is not happening until 2026, creating some uncertainty in the short term.
Insights
FDA awarded a non-transferrable CNPV voucher for daraxonrasib; Phase 3 readout expected in 2026.
Revolution Medicines’ receipt of the CNPV for daraxonrasib (RMC-6236) signals the FDA’s recognition of the therapeutic potential this RAS(ON) multi-selective inhibitor holds. Currently undergoing Phase 3 trials – RASolute 302 (metastatic pancreatic ductal adenocarcinoma) and RASolve 301 (metastatic non-small cell lung cancer) – it directly targets RAS proteins, which are mutated in a substantial proportion of cancer patients. Unlike some targeted therapies focusing on specific RAS mutations like G12C, daraxonrasib boasts a multi-selective mechanism, potentially offering a broader therapeutic reach, though also comes with possible increased risks of off-target effects, so it will need to be closely monitored.
The non-transferable nature of this CNPV does raise some interesting questions. Companies can often sell or transfer these vouchers, generating immediate cash flow. Revolution Medicines’ decision to retain the voucher emphasizes their strategic commitment to internally developing and commercializing daraxonrasib, however it also limits some of their flexibility to partner later if the clinical data is more limited. While the company maintained that they are not changing timelines, the voucher can speed up FDA drug review. The true value of the voucher hinges on robust Phase 3 trial outcomes and successful navigation of the regulatory pathway, therefore clinical and regulatory execution will be key, and will be something for investors to watch for.
Investors will be keen to analyze the data readout from the RASolute 302 trial in 2026 and to listen for details on how Revolution Medicines is collaborating with the FDA on the CNPV pilot program. These developments will offer some clear direction for the long-term development and revenue potential of this drug.
10/16/2025 – 08:00 PM
REDWOOD CITY, Calif., Oct. 16, 2025 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company focused on developing targeted therapies for patients with RAS-addicted cancers, reported 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 currently 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 designed the CNPV pilot program to accelerate the development and review of drugs and biological products aligned with U.S. national health priorities.
Revolution Medicines actively investigating the implications of using the CNPV pilot program and stated that they do not plan to change timelines at this time.
About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor that has the potential to help address cancers driven by oncogenic RAS mutations. Daraxonrasib works to suppress RAS signaling by potentially blocking the interaction of RAS(ON) with downstream effectors. It targets 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 targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress 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).
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.
FAQ
What did Revolution Medicines (RVMD) announce on October 17, 2025 about daraxonrasib?
The company said the FDA granted a non-transferrable CNPV voucher for daraxonrasib (RMC-6236).
Which Phase 3 trials are testing daraxonrasib and what indications do they target?
Daraxonrasib is in two global Phase 3 trials: RASolute 302 for previously treated metastatic pancreatic ductal adenocarcinoma and RASolve 301 for previously treated metastatic non-small cell lung cancer.
When is the expected data readout for RASolute 302 that could affect RVMD stock timeline?
The company expects a data readout from RASolute 302 in 2026 and is not adjusting previously disclosed timelines.
How does the FDA CNPV voucher awarded to RVMD differ from a tradable voucher?
The announced CNPV voucher is non-transferrable, so it cannot be sold or transferred to another company.
Does the CNPV voucher for daraxonrasib mean FDA approval for RVMD is imminent?
No; the voucher aims to accelerate review options, but daraxonrasib remains investigational and is in Phase 3 trials.
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