Revolution Medicines announced FDA approval for daraxonrasib voucher, aimed at treating RAS-addicted cancers in clinical trials.
Quiver AI Summary
Revolution Medicines, Inc. announced that the FDA has granted a non-transferable voucher for its drug daraxonrasib (RMC-6236), a multi-selective inhibitor for RAS-addicted cancers, under the Commissioner's National Priority Voucher pilot program. Daraxonrasib is being evaluated in two Phase 3 trials for metastatic pancreatic and non-small cell lung cancers. This voucher highlights the unmet need for effective treatments in these areas. Revolution Medicines is committed to advancing this investigational drug and anticipates data from one trial in 2026. The company also has a pipeline of RAS(ON) inhibitors to target various oncogenic RAS mutations.
Potential Positives
- The FDA has granted a non-transferrable voucher for daraxonrasib under the Commissioner's National Priority Voucher pilot program, recognizing the potential impact of the drug on treating RAS-addicted cancers.
- Daraxonrasib is in global Phase 3 clinical trials for metastatic pancreatic ductal adenocarcinoma and metastatic non-small cell lung cancer, indicating significant progress in its development.
- The receipt of the voucher aligns with the company's commitment to addressing a large unmet need for new treatments in oncology, which could enhance its reputation and attractiveness to investors.
- The company anticipates a data readout from one of its pivotal trials (RASolute 302) in 2026, suggesting upcoming milestones that could further advance their product pipeline and market position.
Potential Negatives
- The company's reliance on the FDA's CNPV voucher program suggests significant unmet needs in their target market and raises questions about the effectiveness and urgency of their therapies.
- Daraxonrasib is still in a late-stage clinical trial (Phase 3), which indicates that it may not reach the market soon, potentially delaying financial returns for the company.
- The press release emphasizes forward-looking statements, highlighting the uncertainty and risks associated with their drug development, which may lead to investor concerns about the viability and timeline of their proposed treatments.
FAQ
What is daraxonrasib and its purpose?
Daraxonrasib (RMC-6236) is a targeted therapy aimed at treating RAS-addicted cancers by inhibiting RAS signaling.
What does the FDA's voucher mean for daraxonrasib?
The FDA's voucher facilitates accelerated development and review processes for daraxonrasib under health priority initiatives.
What are the ongoing trials for daraxonrasib?
Daraxonrasib is currently being studied in Phase 3 trials for metastatic pancreatic and non-small cell lung cancers.
Who is Revolution Medicines?
Revolution Medicines, Inc. is a late-stage oncology company focused on developing targeted therapies for cancers affected by RAS mutations.
When can we expect data from the trials?
The RASolute 302 trial is expected to yield data readouts in 2026 for daraxonrasib.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$RVMD Insider Trading Activity
$RVMD insiders have traded $RVMD stock on the open market 21 times in the past 6 months. Of those trades, 0 have been purchases and 21 have been sales.
Here’s a breakdown of recent trading of $RVMD stock by insiders over the last 6 months:
- STEPHEN MICHAEL KELSEY (See Remarks) has made 0 purchases and 7 sales selling 159,656 shares for an estimated $7,188,067.
- MARK A GOLDSMITH (See Remarks) has made 0 purchases and 2 sales selling 26,907 shares for an estimated $1,152,103.
- JACK ANDERS (Chief Financial Officer) has made 0 purchases and 4 sales selling 14,490 shares for an estimated $593,737.
- MARGARET A HORN (Chief Operating Officer) has made 0 purchases and 2 sales selling 8,285 shares for an estimated $358,617.
- JEFF CISLINI (General Counsel) has made 0 purchases and 4 sales selling 7,458 shares for an estimated $315,807.
- LIN WEI (Chief Medical Officer) has made 0 purchases and 2 sales selling 4,333 shares for an estimated $185,532.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$RVMD Hedge Fund Activity
We have seen 163 institutional investors add shares of $RVMD stock to their portfolio, and 127 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- BLACKROCK, INC. removed 6,030,999 shares (-41.0%) from their portfolio in Q2 2025, for an estimated $221,880,453
- T. ROWE PRICE INVESTMENT MANAGEMENT, INC. added 3,015,869 shares (+180.2%) to their portfolio in Q2 2025, for an estimated $110,953,820
- DEERFIELD MANAGEMENT COMPANY, L.P. added 2,492,485 shares (+279.6%) to their portfolio in Q2 2025, for an estimated $91,698,523
- WELLINGTON MANAGEMENT GROUP LLP removed 1,528,183 shares (-13.0%) from their portfolio in Q2 2025, for an estimated $56,221,852
- BAKER BROS. ADVISORS LP added 1,428,000 shares (+18.0%) to their portfolio in Q2 2025, for an estimated $52,536,120
- CITADEL ADVISORS LLC added 1,344,608 shares (+1010.5%) to their portfolio in Q2 2025, for an estimated $49,468,128
- MILLENNIUM MANAGEMENT LLC added 1,224,488 shares (+783.2%) to their portfolio in Q2 2025, for an estimated $45,048,913
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$RVMD Analyst Ratings
Wall Street analysts have issued reports on $RVMD in the last several months. We have seen 9 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Stifel issued a "Buy" rating on 10/16/2025
- Goldman Sachs issued a "Buy" rating on 09/12/2025
- Wedbush issued a "Outperform" rating on 09/11/2025
- Wells Fargo issued a "Overweight" rating on 09/11/2025
- Needham issued a "Buy" rating on 09/11/2025
- Piper Sandler issued a "Overweight" rating on 08/19/2025
- Guggenheim issued a "Buy" rating on 06/25/2025
To track analyst ratings and price targets for $RVMD, check out Quiver Quantitative's $RVMD forecast page.
$RVMD Price Targets
Multiple analysts have issued price targets for $RVMD recently. We have seen 13 analysts offer price targets for $RVMD in the last 6 months, with a median target of $75.0.
Here are some recent targets:
- Laura Prendergast from Stifel set a target price of $85.0 on 10/16/2025
- Sean McCutcheon from Raymond James set a target price of $72.0 on 09/12/2025
- Andrea Newkirk from Goldman Sachs set a target price of $73.0 on 09/12/2025
- Robert Driscoll from Wedbush set a target price of $77.0 on 09/11/2025
- Eva Fortea Verdejo from Wells Fargo set a target price of $70.0 on 09/11/2025
- Ami Fadia from Needham set a target price of $66.0 on 09/11/2025
- Asthika Goonewardene from Truist Securities set a target price of $99.0 on 09/05/2025
Full Release
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
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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.
Revolution Medicines Media & Investor Contact:
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