Revolution Medicines’ RAS(ON) Multi-Selective Inhibitor Daraxonrasib Granted U.S. FDA Orphan Drug Designation in Pancreatic Cancer
Revolution Medicines (NASDAQ: RVMD) announced on October 27, 2025 that the U.S. FDA granted Orphan Drug Designation to daraxonrasib for the treatment of pancreatic cancer.
Daraxonrasib is a RAS(ON) multi-selective inhibitor currently being studied in a global Phase 3 RASolute 302 trial for second-line metastatic pancreatic ductal adenocarcinoma (PDAC). The company also plans two additional Phase 3 trials: one for first-line metastatic PDAC and one for adjuvant treatment in resectable PDAC.
The designation makes daraxonrasib eligible for incentives, including tax credits for clinical trial costs, exemption from certain FDA fees, and up to seven years of market exclusivity if approved.
Revolution Medicines (NASDAQ: RVMD) ha annunciato il 27 ottobre 2025 che la FDA statunitense ha concesso Orphan Drug Designation a daraxonrasib per il trattamento del cancro al pancreas.
Daraxonrasib è un inibitore multi-selettivo RAS(ON) attualmente in fase di studio in un trial globale Phase 3 RASolute 302 per il cancro pancreatico ductale metastatico in seconda linea (PDAC). L'azienda prevede anche due ulteriori studi Phase 3: uno per PDAC metastatico in prima linea e uno per il trattamento adiuvante nel PDAC operabile.
La designazione rende daraxonrasib idoneo per incentivi, tra cui crediti d'imposta per i costi degli studi clinici, esenzione da alcune tariffe FDA e fino a sette anni di esclusività di mercato se approvato.
Revolution Medicines (NASDAQ: RVMD) anunció el 27 de octubre de 2025 que la FDA de EE. UU. concedió Orphan Drug Designation a daraxonrasib para el tratamiento del cáncer de páncreas.
Daraxonrasib es un inhibidor multi-seleccionable de RAS(ON) que actualmente se está estudiando en un ensayo global Phase 3 RASolute 302 para carcinoma ductal pancreático metastásico en segunda línea (PDAC). La empresa también planea dos ensayos Phase 3 adicionales: uno para PDAC metastásico en primera línea y otro para tratamiento adyuvante en PDAC resecable.
La designación hace que daraxonrasib sea elegible para incentivos, entre ellos créditos fiscales para costos de ensayos clínicos, exención de ciertas tarifas de la FDA y hasta siete años de exclusividad de mercado si se aprueba.
Revolution Medicines (NASDAQ: RVMD)는 2025년 10월 27일 미국 FDA가 다라окс나르시브(daraxonrasib)에게 파인차암 치료제로 Orphan Drug Designation을 부여했다고 발표했다.
Daraxonrasib은 현재 글로벌 Phase 3 RASolute 302 임상에서 2차 치료로 진행 중인 전이성 췌장암 PDAC의 다중 선택적 RAS(ON) 억제제이다. 이 회사는 또한 Phase 3의 추가 두 임상을 계획하고 있다: 하나는 1차 치료 전이성 PDAC를 위한 것이고, 다른 하나는 절제 가능 PDAC에서 보조 치료이다.
이 지정은 다라옥스나르시브를 임상시험 비용에 대한 세액 공제, 일부 FDA 수수료 면제, 승인 시 최대 7년의 시장 독점권 등 인센티브를 받을 자격을 부여한다.
Revolution Medicines (NASDAQ: RVMD) a annoncé le 27 octobre 2025 que la FDA américaine a accordé le Orphan Drug Designation à daraxonrasib pour le traitement du cancer du pancréas.
Daraxonrasib est un inhibiteur multi-sélectif RAS(ON) actuellement en étude dans un essai mondial Phase 3 RASolute 302 pour un adénocarcinome pancréatique ductal métastatique en deuxième ligne (PDAC). L'entreprise prévoit également deux essais Phase 3 supplémentaires: l'un pour le PDAC métastatique en première ligne et l'autre pour un traitement adjuvant dans le PDAC résécable.
Cette designation rend daraxonrasib éligible à des incitations, notamment crédits d'impôt pour les coûts des essais cliniques, l'exemption de certains frais de la FDA, et jusqu'à sept ans d'exclusivité du marché si approuvé.
Revolution Medicines (NASDAQ: RVMD) gab am 27. Oktober 2025 bekannt, dass die US-amerikanische FDA Orphan Drug Designation für daraxonrasib zur Behandlung von Bauchspeicheldrüsenkrebs gewährt hat.
Daraxonrasib ist ein RAS(ON) Multi-Selective Inhibitor, der derzeit in einer globalen Phase 3 RASolute 302-Studie als Zweitlinien-Therapie beim metastatischen Pankreaskopfkrebs (PDAC) untersucht wird. Das Unternehmen plant außerdem zwei weitere Phase 3-Studien: eine für Erstlinienmetastasierung des PDAC und eine für eine adjuvante Behandlung beim resezierbaren PDAC.
Die Designation macht daraxonrasib für Anreize berechtigt, darunter Steuergutschriften für die Kosten klinischer Studien, Befreiung von bestimmten FDA-Gebühren und bis zu sieben Jahren Marktexklusivität, falls genehmigt.
Revolution Medicines (NASDAQ: RVMD) أعلنت في 27 أكتوبر 2025 أن FDA الأمريكية منحت Orphan Drug Designation لـدارأكسونراسِب لعلاج سرطان البنكرياس.
دارأكسونراسِب هو مثبِّط RAS(ON) متعدد الانتقاء يُدرَس حاليًا في تجربة عالمية من المرحلة Phase 3 RASolute 302 لعلاج السرطان القنوات البنكرياسية الغدية المتقدمة في الخط الثاني. كما تخطط الشركة لإجراء تجربتين إضافيتين من المرحلة 3: إحداهما للـ PDAC المتقدم في الخط الأول والأخرى للعلاج المساعد في PDAC القابل للجراحة.
التعيين يجعل دارأكسونراسِب مؤهلاً للحصول على حوافز، بما في ذلك اعتمادات ضريبية لتكاليف التجارب السريرية، وإعفاء من بعض رسوم FDA، وبحد أقصى سبع سنوات من الحصرية السوقية إذا تمت الموافقة.
Revolution Medicines (NASDAQ: RVMD) 于 2025年10月27日 宣布，美国食品与药物管理局（FDA）已授予 同类药物指定（Orphan Drug Designation） 给 daraxonrasib，用于治疗胰腺癌。
Daraxonrasib 是一种 RAS(ON) 多靶向抑制剂，当前正在全球 Phase 3 RASolute 302 试验中研究，作为二线转移性胰腺导管腺癌（PDAC）的治疗。公司还计划另外两个 Phase 3 试验：一个用于一线转移性 PDAC，另一个用于可切除 PDAC 的辅助治疗。
该指定使 daraxonrasib 的潜在激励包括用于临床试验成本的 税收抵免、免除某些 FDA 费用，以及若获批可获得长达 七年 的市场独占期。
- FDA Orphan Drug Designation for daraxonrasib dated October 27, 2025
- Daraxonrasib enrolled in global Phase 3 RASolute 302 trial
- Plans announced for two additional Phase 3 pancreatic cancer trials
- Designation yields tax credits and exemption from certain FDA fees
- Potential up to seven years of market exclusivity if approved
- Daraxonrasib is not approved; currently investigational in Phase 3 trials
- No trial readout dates or approval timelines specified in the announcement
Insights
Orphan designation for daraxonrasib strengthens regulatory incentives and supports Phase 3 development in pancreatic cancer.
Daraxonrasib now holds U.S. FDA Orphan Drug Designation for pancreatic cancer, which grants incentives such as tax credits, certain fee waivers, and up to seven years of market exclusivity post-approval; the program sits alongside an ongoing global Phase 3 trial, RASolute 302, in second-line metastatic PDAC and announced plans for two additional Phase 3 studies for first-line metastatic and adjuvant resectable PDAC.
The business mechanism is straightforward: orphan status reduces development costs and can improve post-approval commercial protections, which may materially affect program economics if the trials lead to approval. Key dependencies include successful demonstration of clinical benefit in the ongoing and planned Phase 3 trials and subsequent regulatory review; these remain the gating items and are not resolved by the designation alone.
Watch for readouts and regulatory interactions tied to RASolute 302 and the initiation milestones for the two planned Phase 3 trials; near-term signals will come from enrollment progress, interim analyses, and any regulatory guidance meetings. Expect these milestones to unfold over the clinical-phase timelines typical for late-stage oncology development, with the most informative events being trial results and any formal FDA review steps following submission.
REDWOOD CITY, Calif., Oct. 27, 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 Orphan Drug Designation to daraxonrasib, the company’s RAS(ON) multi-selective inhibitor, for the treatment of pancreatic cancer.
“We are gratified the FDA has granted Orphan Drug Designation to daraxonrasib for the treatment of pancreatic cancer, a devastating disease with limited therapeutic options and representing a large unmet medical need,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “RAS driver mutations are present in nearly all pancreatic cancer cases, underscoring the urgent need for innovative therapies that target this critical driver of disease progression.”
Daraxonrasib is being studied in a global Phase 3 clinical trial, RASolute 302, in patients with second line metastatic pancreatic ductal adenocarcinoma (PDAC). The company has also announced plans to initiate two additional Phase 3 clinical trials in pancreatic cancer: a trial for first line treatment in patients with metastatic PDAC and a trial for adjuvant treatment in patients with resectable PDAC.
Orphan Drug Designation is awarded by the FDA on behalf of selected investigational drugs to encourage the development of therapies for rare diseases, which are defined as conditions affecting fewer than 200,000 individuals in the United States. This designation provides sponsors with several incentives, including tax credits for clinical trial costs, exemption from certain FDA fees, and up to seven years of market exclusivity following approval.
About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people will be diagnosed annually with pancreatic cancer1, and about 50,000 people will die from this aggressive disease.
Due to the lack of early symptoms and detection methods, approximately
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, including statements about the Company’s plans to initiate additional Phase 3 trials in first line PDAC and in patients with resectable PDAC. Forward-looking statements are typically, but not always, identified by the use of words such as "will," "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:
media@revmed.com
investors@revmed.com
1 Siegel RL, et al. CA Cancer J Clin. 2024;74:12-49.
2 Lee JK, Sivakumar S, Schrock AB, et al. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors. NPJ Precis Oncol. 2022;6(1);91. Doi:10.1038/s41698-022-00334-z.
3 American Cancer Society. Survival Rates for Pancreatic Cancer. Available at: https://www.cancer.org/cancer/types/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html. Accessed June 2025.
FAQ
What did Revolution Medicines announce about daraxonrasib on October 27, 2025 (RVMD)?
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