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[8-K] Revolution Medicines, Inc. Reports Material Event

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Revolution Medicines (RVMD) announced an FDA milestone. On October 16, 2025, the U.S. Food and Drug Administration granted the company a non‑transferrable voucher for daraxonrasib, its RAS(ON) multi‑selective inhibitor, under the Commissioner’s National Priority Voucher pilot program.

This update signals regulatory recognition tied to daraxonrasib’s program status. The voucher is non‑transferrable and is associated specifically with the FDA’s pilot initiative. No financial terms or commercial arrangements were disclosed in this notice.

Revolution Medicines (RVMD) ha annunciato una tappa normativa della FDA. Il 16 ottobre 2025, la Food and Drug Administration statunitense ha concesso all'azienda un voucher non trasferibile per daraxonrasib, il suo inibitore multi-selettivo RAS(ON), nell'ambito del programma pilota National Priority Voucher della FDA.

Questo aggiornamento segnala un riconoscimento regolatorio legato allo stato del programma di daraxonrasib. Il voucher è non trasferibile e è associato specificamente all'iniziativa pilota della FDA. Nessun termine finanziario o accordi commerciali sono stati divulgati in questa comunicazione.

Revolution Medicines (RVMD) anunció un hito de la FDA. El 16 de octubre de 2025, la Administración de Alimentos y Medicamentos de EE. UU. concedió a la empresa un voucher no transferible para daraxonrasib, su inhibidor multi-selectivo RAS(ON), dentro del programa piloto de vouchers de prioridad nacional de la FDA.

Esta actualización indica un reconocimiento regulatorio vinculado al estado del programa de daraxonrasib. El voucher es no transferible y está asociado específicamente con la iniciativa piloto de la FDA. En este aviso no se divulgaron términos financieros ni acuerdos comerciales.

리볼루션 메디슨스(RVMD)가 FDA의 이정표를 발표했습니다. 2025년 10월 16일 미국 식품의약국(FDA)은 다라옥손라시브의 비양도 가능한 바우처를 승인했습니다. 다라옥손라시브는 RAS(ON) 다중 선택 억제제이며, 이 바우처는 커미셔너의 National Priority Voucher 파일럿 프로그램에 따라 부여되었습니다.

이 소식은 다라옥손라시브의 프로그램 상태와 관련된 규제 인정을 시사합니다. 이 바우처는 양도 불가능하며 FDA의 파일럿 이니셔티브에 특정하게 연결되어 있습니다. 이 공지에는 재정적 조건이나 상업적 합의가 공개되지 않았습니다.

Revolution Medicines (RVMD) a annoncé une étape de la FDA. Le 16 octobre 2025, la Food and Drug Administration américaine a accordé à l'entreprise un bon non transférable pour daraxonrasib, son inhibiteur multi-sélectif RAS(ON), dans le cadre du programme pilote de bons Nationaux de Priorité du Commissaire.

Cette mise à jour signale une reconnaissance réglementaire liée à l'état du programme de daraxonrasib. Le bon est non transférable et est associé spécifiquement à l'initiative pilote de la FDA. Aucun terme financier ou accord commercial n'a été divulgué dans cet avis.

Revolution Medicines (RVMD) hat einen FDA-Meilenstein bekannt gegeben. Am 16. Oktober 2025 hat die US-amerikanische Food and Drug Administration dem Unternehmen einen nicht übertragbaren Gutschein für Daraxonrasib, seinen RAS(ON)-Multi-Selektiv-Inhibitor, im Rahmen des Pilotprogramms des Commissioner’s National Priority Voucher gewährt.

Dieses Update signalisiert regulatorische Anerkennung in Bezug auf den Status des Daraxonrasib-Programms. Der Gutschein ist nicht übertragbar und ist speziell mit der FDA-Pilotinitiative verbunden. In dieser Mitteilung wurden keine finanziellen Bedingungen oder kommerziellen Vereinbarungen offengelegt.

أعلنت Revolution Medicines (RVMD) عن إنجاز رئيسي لدى FDA. في 16 أكتوبر 2025، منحت إدارة الغذاء والدواء الأمريكية الشركة قسيمة غير قابلة للتحويل لـ داراكسونراسِب، مثبط RAS(ON) متعدد الانتقاء، في إطار برنامج تجريبي لقسائم الأولوية الوطنية للمفوّض.

هذه التحديث يشير إلى اعتراف تنظيمي مرتبط بحالة برنامج داراكسونراسِب. القسيمة غير قابلة للتحويل وترتبط تحديداً بمبادرة FDA التجريبية. لم يتم الكشف عن أي شروط مالية أو ترتيبات تجارية في هذه الإخطار.

Revolution Medicines (RVMD) 宣布了一个FDA里程碑。 2025年10月16日,美国食品药品监督管理局向该公司授予了一种不可转让的 Daraxonrasib 优先券,它是其 RAS(ON) 多靶向抑制剂,属于委员会专员国家优先券试点计划。

此更新表明与 Daraxonrasib 项目状态相关的监管认可。该券不可转让,并专门与FDA的试点计划相关联。公告中未披露任何财务条款或商业安排。

Positive
  • None.
Negative
  • None.

Insights

FDA granted RVMD a non‑transferrable voucher for daraxonrasib.

Revolution Medicines reported that the FDA granted a non‑transferrable voucher for daraxonrasib on October 16, 2025 under the Commissioner’s National Priority Voucher pilot program. The filing links the voucher specifically to the company’s RAS(ON) multi‑selective inhibitor.

The announcement indicates a defined FDA action tied to a pilot program. The filing does not outline mechanics, tradability beyond "non‑transferrable," or financial implications. Any operational impact would depend on program details not included here.

Subsequent disclosures may clarify how the voucher interacts with daraxonrasib’s development path or regulatory timelines, if applicable.

Revolution Medicines (RVMD) ha annunciato una tappa normativa della FDA. Il 16 ottobre 2025, la Food and Drug Administration statunitense ha concesso all'azienda un voucher non trasferibile per daraxonrasib, il suo inibitore multi-selettivo RAS(ON), nell'ambito del programma pilota National Priority Voucher della FDA.

Questo aggiornamento segnala un riconoscimento regolatorio legato allo stato del programma di daraxonrasib. Il voucher è non trasferibile e è associato specificamente all'iniziativa pilota della FDA. Nessun termine finanziario o accordi commerciali sono stati divulgati in questa comunicazione.

Revolution Medicines (RVMD) anunció un hito de la FDA. El 16 de octubre de 2025, la Administración de Alimentos y Medicamentos de EE. UU. concedió a la empresa un voucher no transferible para daraxonrasib, su inhibidor multi-selectivo RAS(ON), dentro del programa piloto de vouchers de prioridad nacional de la FDA.

Esta actualización indica un reconocimiento regulatorio vinculado al estado del programa de daraxonrasib. El voucher es no transferible y está asociado específicamente con la iniciativa piloto de la FDA. En este aviso no se divulgaron términos financieros ni acuerdos comerciales.

리볼루션 메디슨스(RVMD)가 FDA의 이정표를 발표했습니다. 2025년 10월 16일 미국 식품의약국(FDA)은 다라옥손라시브의 비양도 가능한 바우처를 승인했습니다. 다라옥손라시브는 RAS(ON) 다중 선택 억제제이며, 이 바우처는 커미셔너의 National Priority Voucher 파일럿 프로그램에 따라 부여되었습니다.

이 소식은 다라옥손라시브의 프로그램 상태와 관련된 규제 인정을 시사합니다. 이 바우처는 양도 불가능하며 FDA의 파일럿 이니셔티브에 특정하게 연결되어 있습니다. 이 공지에는 재정적 조건이나 상업적 합의가 공개되지 않았습니다.

Revolution Medicines (RVMD) a annoncé une étape de la FDA. Le 16 octobre 2025, la Food and Drug Administration américaine a accordé à l'entreprise un bon non transférable pour daraxonrasib, son inhibiteur multi-sélectif RAS(ON), dans le cadre du programme pilote de bons Nationaux de Priorité du Commissaire.

Cette mise à jour signale une reconnaissance réglementaire liée à l'état du programme de daraxonrasib. Le bon est non transférable et est associé spécifiquement à l'initiative pilote de la FDA. Aucun terme financier ou accord commercial n'a été divulgué dans cet avis.

Revolution Medicines (RVMD) hat einen FDA-Meilenstein bekannt gegeben. Am 16. Oktober 2025 hat die US-amerikanische Food and Drug Administration dem Unternehmen einen nicht übertragbaren Gutschein für Daraxonrasib, seinen RAS(ON)-Multi-Selektiv-Inhibitor, im Rahmen des Pilotprogramms des Commissioner’s National Priority Voucher gewährt.

Dieses Update signalisiert regulatorische Anerkennung in Bezug auf den Status des Daraxonrasib-Programms. Der Gutschein ist nicht übertragbar und ist speziell mit der FDA-Pilotinitiative verbunden. In dieser Mitteilung wurden keine finanziellen Bedingungen oder kommerziellen Vereinbarungen offengelegt.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 16, 2025

 

 

REVOLUTION MEDICINES, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39219   47-2029180

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

700 Saginaw Drive  
Redwood City, California   94063
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (650) 481-6801

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol

 

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share   RVMD   The Nasdaq Stock Market LLC
Warrants to purchase 0.1112 shares of common stock expiring 2026   RVMDW   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 


Item 8.01

Other Events.

On October 16, 2025, Revolution Medicines, Inc. (the “Company”) announced that the U.S. Food and Drug Administration has granted the Company a non-transferrable voucher for daraxonrasib, the Company’s RAS(ON) multi-selective inhibitor, under the Commissioner’s National Priority Voucher pilot program.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    REVOLUTION MEDICINES, INC.
Date: October 16, 2025     By:  

/s/ Mark A. Goldsmith

      Mark A. Goldsmith, M.D., Ph.D.
      President and Chief Executive Officer

FAQ

What did RVMD announce on October 16, 2025?

RVMD announced the FDA granted a non‑transferrable voucher for daraxonrasib under the Commissioner’s National Priority Voucher pilot program.

Which RVMD program is associated with the FDA voucher?

The voucher is associated with daraxonrasib, RVMD’s RAS(ON) multi‑selective inhibitor.

Is the FDA voucher transferrable?

No. The company states the voucher is non‑transferrable.

What FDA initiative is referenced in RVMD’s update?

The Commissioner’s National Priority Voucher pilot program.

Did RVMD disclose financial terms related to the voucher?

No financial terms or commercial details are included in the announcement.
Revolution Medicines, Inc.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States
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