Revolution Medicines Awarded Voucher for Daraxonrasib (RMC-6236) Under FDA Commissioner's National Priority Voucher Pilot Program
Revolution Medicines (Nasdaq: RVMD) announced the U.S. FDA granted a non-transferrable Commissioner's National Priority Voucher (CNPV) for daraxonrasib (RMC-6236), its RAS(ON) multi-selective inhibitor.
Daraxonrasib is in two global Phase 3 trials: RASolute 302 (previously treated metastatic pancreatic ductal adenocarcinoma) and RASolve 301 (previously treated metastatic non-small cell lung cancer). The company noted a expected data readout from RASolute 302 in 2026 and said it is evaluating the voucher's impact without changing previously disclosed timelines.
Revolution Medicines (Nasdaq: RVMD) ha annunciato che la FDA degli Stati Uniti ha concesso un voucher nazionale prioritario non trasferibile del Commissario (CNPV) per daraxonrasib (RMC-6236), il suo inibitore multi-selettivo RAS(ON).
Daraxonrasib è in due studi globali di fase 3: RASolute 302 (carcinoma pancreatico duttale metastatico precedentemente trattato) e RASolve 301 (carcinoma polmonare non a piccole cellule metastatico precedentemente trattato). L'azienda ha segnalato una letura dei dati attesa da RASolute 302 nel 2026 e ha dichiarato di valutare l'impatto del voucher senza modificare i tempi già comunicati.
Revolution Medicines (Nasdaq: RVMD) anunció que la FDA de EE. UU. concedió un Voucher Nacional de Prioridad otorgable no transferible del Comisionado (CNPV) para daraxonrasib (RMC-6236), su inhibidor multi-selecivo RAS(ON).
Daraxonrasib está en dos ensayos globales de fase 3: RASolute 302 (cáncer ductal pancreático metastásico previamente tratado) y RASolve 301 (cáncer de pulmón de células no pequeñas metastásico previamente tratado). La empresa señaló una lectura de datos esperada de RASolute 302 en 2026 y dijo que está evaluando el impacto del voucher sin cambiar los plazos ya divulgados.
리볼루션 의약품(나스닥: RVMD)가 미국 FDA가 다라록사라십(RMC-6236), 자사의 RAS(ON) 다중 선택적 억제제에 대해 양도 불가한 국가지정 우선 바우처(CNPV)를 부여했다고 발표했습니다.
다라록사라십은 전 세계 3상 연구 2건에 있습니다: RASolute 302(이전 치료를 받은 전이성 췌장관 샤미암종) 및 RASolve 301(이전 치료를 받은 전이성 비소세포폐암). 회사는 RASolute 302의 데이터 발표가 2026년에 예상된다고 지적했고, 바우처의 영향을 평가하면서 이미 공시된 일정은 변경하지 않는다고 밝혔습니다.
Revolution Medicines (NASDAQ : RVMD) a annoncé que la FDA américaine a accordé un voucher national prioritaire du Commissaire non transférable (CNPV) pour daraxonrasib (RMC-6236), son inhibiteur multi-sélectif RAS(ON).
Le daraxonrasib est dans deux essais mondiaux de phase 3 : RASolute 302 (cancer du pancréas métastatique après traitement) et RASolve 301 (cancer du poumon non à petites cellules métastatique après traitement). La société a noté une lecture des données attendue de RASolute 302 en 2026 et a déclaré qu'elle évaluait l'impact du voucher sans changer les délais déjà annoncés.
Revolution Medicines (Nasdaq: RVMD) gab bekannt, dass die US-amerikanische FDA einen nicht übertragbaren National Priority Voucher des Commissioners (CNPV) für Daraxonrasib (RMC-6236), seinen RAS(ON)-Multi-Selective-Inhibitor, gewährt hat.
Daraxonrasib befindet sich in zwei globalen Phase-3-Studien: RASolute 302 (früher behandeltes metastasierendes pankreatisches Duktal-Karzinom) und RASolve 301 (früheres metastasierendes nicht-kleinzelliges Lungenkarzinom). Das Unternehmen vermerkte eine erwartete Datenpublikation von RASolute 302 im Jahr 2026 und erklärte, dass es die Auswirkungen des Vouchers bewertet, ohne die bereits bekannt gegebenen Zeitpläne zu ändern.
Revolution Medicines (بورصة ناسداك: RVMD) أعلنت أن إدارة الغذاء والدواء الأمريكية منحت قسيمة أولوية وطنية للمفوض غير قابلة للنقل (CNPV) لدواء داراكسونراسِب (RMC-6236)، وهو مثبِّط راس(ON) متعدد الانتقاء.
داراكسونراسِب موجود في تجربتين عالميتين من المرحلة الثالثة: RASolute 302 (سرطان البنكرياس النسيجي المنتشر الذي عُولج سابقاً) وRASolve 301 (سرطان الرئة المتقدم النسيجي المنتشر الذي عُولج سابقاً). أشارت الشركة إلى إخراج بيانات متوقع من RASolute 302 في 2026، وقالت إنها تقيم تأثير القسيمة مع عدم تعديل الجداول الزمنية المعلنة سابقاً.
Revolution Medicines (纳斯达克：RVMD) 宣布，美国食品药品监督管理局授予一张 不可转让的专员国家优先券（CNPV），用于 daraxonrasib (RMC-6236)，这是其 RAS(ON) 多靶向选择性抑制剂。
Daraxonrasib 正处于两项全球 3期临床试验：RASolute 302（既往治疗的转移性胰腺导管腺癌）和 RASolve 301（既往治疗的转移性非小细胞肺癌）。公司指出预计在 2026 年公布 RASolute 302 的数据 并表示在评估券的影响，同时不改变已披露的时间表。
- FDA awarded a CNPV voucher for daraxonrasib
- Daraxonrasib in two global Phase 3 trials (RASolute 302, RASolve 301)
- Expected RASolute 302 data readout in 2026
- Daraxonrasib previously received Breakthrough Therapy designation
- Voucher is explicitly non-transferrable, limiting sale/monetization options
- No regulatory approval yet; drug remains investigational in Phase 3
- Clinical readout limited to 2026, leaving near-term uncertainty for investors
Insights
FDA awarded a non-transferrable CNPV voucher for daraxonrasib; Phase 3 readout expected in
Revolution Medicines received a Commissioner's National Priority Voucher under the FDA pilot program for daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor currently in two global Phase 3 trials: RASolute 302 (previously treated metastatic pancreatic ductal adenocarcinoma) and RASolve 301 (previously treated metastatic non-small cell lung cancer). The voucher is explicitly non-transferrable and complements the previously granted Breakthrough Therapy designation mentioned in the release.
The practical impact depends on regulatory interactions and the Phase 3 results; the company states it is evaluating the voucher and is not changing disclosed timelines. The FDA designed the CNPV pilot to accelerate development and review for products aligning with national health priorities, so the voucher may provide programmatic benefits during the review process if filings proceed. Delivery of value rests on the confirmed trial outcomes and subsequent regulatory steps.
Watch for the concrete trial milestone: the expected RASolute 302 data readout in
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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FAQ
What did Revolution Medicines (RVMD) announce on October 17, 2025 about daraxonrasib?
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