Revolution Medicines' Daraxonrasib Receives FDA Breakthrough Therapy Designation for Metastatic Pancreatic Ductal Adenocarcinoma

Revolution Medicines' daraxonrasib receives FDA Breakthrough Therapy Designation for treating metastatic pancreatic cancer with specific KRAS mutations.

Quiver AI Summary

Revolution Medicines, Inc. announced that the U.S. FDA has granted Breakthrough Therapy Designation to daraxonrasib, a multi-selective inhibitor targeting KRAS G12 mutations in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). This designation is based on promising early clinical evidence from a Phase 1 trial. The company's RASolute 302 study, which aims to enroll patients with RAS mutations, is expected to complete enrollment this year, with results anticipated in 2026. Daraxonrasib has the potential to offer new treatment options for a significant number of patients, as over 90% of those with PDAC have RAS mutations. Revolution Medicines is committed to advancing daraxonrasib and is working with regulatory agencies to facilitate its introduction to patients should future studies validate its efficacy.

Potential Positives

Revolution Medicines received Breakthrough Therapy Designation from the FDA for daraxonrasib, a significant recognition that can accelerate the development and review process for this potential treatment of metastatic pancreatic ductal adenocarcinoma (PDAC).
The designation highlights the encouraging clinical evidence from early trials, suggesting daraxonrasib may offer substantial improvements over existing therapies for patients with KRAS G12 mutations.
The ongoing Phase 3 RASolute 302 study aims to enroll patients quickly, which can enhance the speed of data collection and potential regulatory filing, further demonstrating the company's commitment to addressing urgent medical needs in pancreatic cancer.
Daraxonrasib targets RAS mutations, which are prevalent in over 90% of PDAC cases, positioning Revolution Medicines as a key player in developing treatments for this critically underserved patient population.

Potential Negatives

The Breakthrough Therapy Designation, while positive, highlights the significant medical need and high mortality rate associated with pancreatic cancer, underscoring the challenges the company faces in addressing this critical health issue.
The press release emphasizes the inherent risks and uncertainties in the drug development process, which could cause the company's future results to differ materially from expectations.
The mention of only preliminary clinical evidence suggests that confidence in the drug's efficacy is not yet fully established, which may raise concerns among investors and stakeholders regarding its eventual approval and market success.

FAQ

What is Daraxonrasib's Breakthrough Therapy Designation?

Daraxonrasib received Breakthrough Therapy Designation from the FDA for previously treated metastatic PDAC with KRAS G12 mutations.

What is the RASolute 302 study?

The RASolute 302 study is a Phase 3 trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma.

Why is Pancreatic Cancer treatment urgent?

Pancreatic cancer has a high mortality rate and most patients are diagnosed at advanced stages, indicating an urgent need for new treatments.

What are the primary endpoints of the RASolute 302 study?

The primary endpoints are progression-free survival (PFS) and overall survival (OS) in the core patient population.

How can I find more information about the RASolute 302 study?

Further details about the RASolute 302 study can be found on clinicaltrials.gov using the identifier NCT06625320.

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 13 times in the past 6 months. Of those trades, 0 have been purchases and 13 have been sales.

Here’s a breakdown of recent trading of $RVMD stock by insiders over the last 6 months:

MARK A GOLDSMITH (See Remarks) has made 0 purchases and 2 sales selling 25,234 shares for an estimated $995,800.
JEFF CISLINI (General Counsel) has made 0 purchases and 4 sales selling 7,783 shares for an estimated $308,172.
STEPHEN MICHAEL KELSEY (See Remarks) has made 0 purchases and 2 sales selling 7,583 shares for an estimated $299,429.
MARGARET A HORN (Chief Operating Officer) has made 0 purchases and 2 sales selling 6,568 shares for an estimated $259,188.
JACK ANDERS (Chief Financial Officer) has made 0 purchases and 2 sales selling 4,034 shares for an estimated $159,202.
LIN WEI (Chief Medical Officer) sold 2,173 shares for an estimated $86,550

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$RVMD Hedge Fund Activity

We have seen 144 institutional investors add shares of $RVMD stock to their portfolio, and 150 decrease their positions in their most recent quarter.

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BOXER CAPITAL MANAGEMENT, LLC removed 2,961,487 shares (-69.2%) from their portfolio in Q1 2025, for an estimated $104,718,180
T. ROWE PRICE INVESTMENT MANAGEMENT, INC. added 1,673,429 shares (+inf%) to their portfolio in Q1 2025, for an estimated $59,172,449
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NEXTECH INVEST LTD. added 1,304,347 shares (+20.7%) to their portfolio in Q4 2024, for an estimated $57,052,137
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$RVMD Analyst Ratings

Wall Street analysts have issued reports on $RVMD in the last several months. We have seen 2 firms issue buy ratings on the stock, and 0 firms issue sell ratings.

Here are some recent analyst ratings:

H.C. Wainwright issued a "Buy" rating on 05/14/2025
UBS issued a "Buy" rating on 01/08/2025

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 3 analysts offer price targets for $RVMD in the last 6 months, with a median target of $71.0.

Here are some recent targets:

Robert Burns from H.C. Wainwright set a target price of $72.0 on 05/14/2025
Benjamin Burnett from Stifel Nicolaus set a target price of $64.0 on 04/01/2025
Eliana Merle from UBS set a target price of $71.0 on 01/08/2025

Full Release

Breakthrough Therapy Designation based on promising early clinical evidence observed with daraxonrasib in patients with pancreatic ductal adenocarcinoma (PDAC)
RASolute 302, a Phase 3 registrational study of daraxonrasib in patients with previously treated metastatic PDAC, expected to substantially complete enrollment this year

REDWOOD CITY, Calif., June 23, 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 Breakthrough Therapy Designation to daraxonrasib, the company’s RAS(ON) multi-selective inhibitor, for previously treated metastatic PDAC in patients with KRAS G12 mutations.

The Breakthrough Therapy Designation is based on encouraging data from the Phase 1 RMC-6236-001 clinical trial evaluating daraxonrasib in patients with previously treated metastatic PDAC.

“This Breakthrough Therapy Designation underscores the enormous need for new treatments for patients with pancreatic cancer and highlights the potentially important role the investigational drug, daraxonrasib, may have in helping patients living with this disease,” said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “We look forward to substantially completing enrollment of the RASolute 302 study this year to enable an expected readout in 2026, and should the results support it, working closely with the FDA and other regulatory agencies around the world to bring daraxonrasib to patients as quickly as possible.”

Breakthrough Therapy Designation is intended to expedite the development and review of potential new medicines designed to treat serious conditions and address significant unmet medical needs. The medicine needs to have shown encouraging preliminary clinical evidence that demonstrates substantial improvement on a clinically significant endpoint over available medicines.

More than 90% of patients living with PDAC have tumors carrying a RAS cancer driver mutation with ~85% carrying a KRAS G12 mutation. Revolution Medicines is currently enrolling patients in RASolute 302, a global Phase 3 registrational study of daraxonrasib in patients with previously treated metastatic PDAC. The study design focuses on a core population of patients with PDAC harboring RAS mutations at position 12 (RAS G12X) and an expanded population that includes patients with tumors harboring RAS mutations at position G12 (RAS G12X), G13 (RAS G13X) or Q61 (RAS Q61X), or those without any identified targetable mutation. The dual primary endpoints for the study are progression-free survival (PFS) and overall survival (OS) in the core patient population. Key secondary endpoints include PFS and OS in the expanded population of patients. Additional information about RASolute 302 (NCT06625320) is available at clinicaltrials.gov .

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 in 2024, approximately 60,000 people will be diagnosed with pancreatic cancer ¹ , and about 50,000 people will die from this aggressive disease.

The most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC) and its variants, accounts for approximately 92% of all pancreatic cancer cases ² . Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations ³ . Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3% ⁴ .

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 progression of clinical studies and findings from these studies, including the safety, tolerability and antitumor activity of the company’s candidates being studied and the durability of these results; dosing and enrollment in the company’s clinical trials; potential regulatory interactions by the company; and the ability of the company to bring its clinical candidates to patients. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "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 May 7, 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:
[email protected]
[email protected]

¹ Siegel RL, et al. CA Cancer J Clin. 2024;74:12-49.
² Hallbrook CJ, et al. Cell. 2023;186:1729-1754.
³ 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.
⁴ 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.