Revolution Medicines Announces First Patient Randomized in the RASolute 304 Clinical Trial of Daraxonrasib in Resectable Pancreatic Ductal Adenocarcinoma Following Adjuvant Chemotherapy

Rhea-AI Summary

Revolution Medicines (NASDAQ:RVMD) announced on Dec 18, 2025 that the first patient was randomized in RASolute 304, a global, open-label Phase 3 trial of daraxonrasib in resectable pancreatic ductal adenocarcinoma (PDAC) after surgery and perioperative chemotherapy.

RASolute 304 plans to enroll approximately 500 patients with oncogenic RAS mutations and will evaluate whether daraxonrasib improves disease-free survival versus observation; secondary endpoints include overall survival, safety, and tolerability. Daraxonrasib is being evaluated in four global Phase 3 trials, including three in PDAC and one in RAS mutant non-small cell lung cancer.

Positive

• First patient randomized in RASolute 304 on Dec 18, 2025
• Planned enrollment of ~500 patients with resectable PDAC and RAS mutations
• Primary endpoint is disease-free survival versus observation
• Daraxonrasib is included in four global Phase 3 trials

Negative

• Trial is open-label, which may complicate endpoint assessment
• No efficacy data yet; only first patient randomized to date

Argus Dec 18 session

-1.02% close to close Open Argus

Details

News Market Reaction – RVMD

In the Dec 18 session, RVMD declined 1.02%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement marks the first patient randomized in RASolute 304, a global Phase 3 trial of dara...

Analysis

This announcement marks the first patient randomized in RASolute 304, a global Phase 3 trial of daraxonrasib in resectable PDAC after surgery and chemotherapy, targeting about 500 patients. It expands daraxonrasib’s footprint to four Phase 3 programs across pancreatic and RAS mutant NSCLC settings. Recent history includes Orphan Drug Designation and robust liquidity of $1.93B dedicated to RAS(ON) development. Investors may watch enrollment pace, disease-free survival outcomes, and any safety updates from the broader Phase 3 portfolio.

Key Figures

Planned enrollment: approximately 500 patients Phase 3 trials: 4 global Phase 3 trials PDAC Phase 3 trials: 3 trials in PDAC +5 more

Planned enrollment

approximately 500 patients

RASolute 304 resectable PDAC Phase 3 trial

Phase 3 trials

4 global Phase 3 trials

Daraxonrasib across PDAC and RAS mutant NSCLC

PDAC Phase 3 trials

3 trials in PDAC

Daraxonrasib programs including adjuvant, first-line and previously treated PDAC

Current price

$76.74

Pre-news trading on Dec 18, 2025

52-week range

$29.17–$81.49

Low–high prior to this announcement

Market cap

$14,993,884,076

Equity value before RASolute 304 update

Cash and securities

$1.93 billion

As of Sept 30, 2025 from 10-Q

Q3 2025 net loss

$305.2 million

Quarter ended Sept 30, 2025

Historical Context

5 past events · Latest: Nov 05

5 events

1. Nov 05

   Earnings and pipeline

   24h Move

   +1.3%

   Q3 2025 results plus RAS(ON) pipeline updates and guidance reaffirmed.

2. Nov 04

   Investor conferences

   24h Move

   -1.3%

   Management participation in November healthcare investor conferences.

3. Oct 29

   Earnings scheduling

   24h Move

   +1.5%

   Announcement of timing for Q3 2025 results and webcast.

4. Oct 27

   Orphan designation

   24h Move

   +6.4%

   FDA Orphan Drug Designation for daraxonrasib in pancreatic cancer.

5. Oct 22

   Clinical data update

   24h Move

   -0.9%

   Updated elironrasib efficacy and safety data in KRAS G12C NSCLC.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 3 clinical trial, resectable pancreatic ductal adenocarcinoma, disease-free survival, overall survival, +4 more

8 terms

phase 3 clinical trial medical

"a global, open-label, Phase 3 clinical trial evaluating the safety"

A phase 3 clinical trial is a large-scale study that tests a new medical treatment or drug to determine if it is safe and effective for widespread use. It often involves hundreds or thousands of participants and compares the new treatment to existing options or a placebo. For investors, the results of this phase are crucial, as successful outcomes can lead to regulatory approval and commercial success, while failures may halt development.

resectable pancreatic ductal adenocarcinoma medical

"in patients with resectable pancreatic ductal adenocarcinoma (PDAC)"

Resectable pancreatic ductal adenocarcinoma is a common type of pancreatic cancer that is still confined enough to the original tumor site that surgeons can remove it completely. For investors, this status matters because resectable disease typically leads to different treatment paths, better short-term prognosis, and distinct market demand for surgery, supportive drugs and diagnostics—like spotting a weed you can still dig out cleanly versus one that has spread roots everywhere.

disease-free survival medical

"The trial will assess whether daraxonrasib can improve disease-free survival"

Disease-free survival measures the length of time after treatment during which a patient shows no signs or symptoms of the disease. For investors, it is a key clinical result because longer disease-free periods suggest a therapy is effective at preventing recurrence, which can drive regulatory approval, market demand and revenue potential—think of it as how long a repaired item runs without breaking down.

overall survival medical

"secondary endpoints include overall survival, safety, and tolerability"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

adjuvant chemotherapy medical

"adenocarcinoma Following Adjuvant Chemotherapy"

Adjuvant chemotherapy is drug treatment given after the main cancer therapy, usually surgery, to kill leftover cancer cells and lower the chance the disease will come back. For investors it matters because approval, clinical success or broader use of adjuvant therapy can expand a drug’s eligible patient pool, influence regulatory decisions and materially change sales and long‑term revenue—like a follow-up insurance policy that determines ongoing demand and value.

non-small cell lung cancer medical

"trial in locally advanced or metastatic RAS mutant non-small cell lung cancer"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

ras(on) multi-selective inhibitor medical

"daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with"

A ras(on) multi-selective inhibitor is a drug designed to block the activity of RAS proteins or the signaling pathway they control, while acting on several related molecular targets rather than just one. For investors, this matters because such drugs can potentially treat a wider range of tumors driven by different RAS mutations — like a multi-tool that fits several bolts — but they also carry higher development and safety risk from affecting multiple biological systems.

peroperative chemotherapy medical

"have undergone resection and completed perioperative chemotherapy"

Peroperative chemotherapy is cancer drug treatment given around the time of a planned surgery — it can include doses before the operation to shrink a tumor, during the operation in some cases, or after surgery to kill leftover cancer cells. For investors, it matters because this approach can change how well surgeries work, alter drug dosing schedules and trial designs, and therefore affect a therapy’s market size, approval chances, and hospital or outpatient usage; think of it like treating soil before and after planting to improve crop yield.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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REDWOOD CITY, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient has been randomized in the RASolute 304 trial. RASolute 304 is a global, open-label, Phase 3 clinical trial evaluating the safety and efficacy of daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with resectable pancreatic ductal adenocarcinoma (PDAC) who have received surgery and chemotherapy.

RASolute 304 is anticipated to enroll approximately 500 patients with PDAC harboring oncogenic RAS mutations who have undergone resection and completed perioperative chemotherapy. The trial will assess whether daraxonrasib can improve disease-free survival compared to observation. The primary endpoint in RASolute 304 is disease-free survival, and secondary endpoints include overall survival, safety, and tolerability.

“We are pleased to begin enrolling patients into RASolute 304, which expands the clinical evaluation of daraxonrasib into another important treatment setting for patients with RAS mutant pancreatic cancer,” said Alan Sandler, M.D., chief development officer of Revolution Medicines. “This trial enables us to investigate daraxonrasib even earlier in the treatment paradigm, which could potentially improve the rate of long-term disease-free survival in patients with resectable pancreatic cancer.”

Daraxonrasib is currently being evaluated in four global Phase 3 clinical trials, including three trials in PDAC and a trial in locally advanced or metastatic RAS mutant non-small cell lung cancer.

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 cancer, and about 50,000 people will die from this aggressive disease.¹

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.² 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%.^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; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in 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; and the potential of daraxonrasib to improve long-term disease-free survival in resectable pancreatic cancer. 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 November 5, 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, Giaquinto AN, Jemal A. Cancer statistics, 2024.  CA Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.21820
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 Halbrook CJ, Lyssiotis CA, Pasca di Magliano M, Maitra A. Pancreatic cancer: Advances and challenges. Cell. 2023;186(8):1729-1754. doi:10.1016/j.cell.2023.02.014
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 December2025.}

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/864b0105-249e-41aa-9420-641ec580a07f

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is RASolute 304 and which company is running it (RVMD)?

RASolute 304 is a global, open-label Phase 3 trial run by Revolution Medicines (NASDAQ:RVMD) testing daraxonrasib in resectable PDAC after surgery and perioperative chemotherapy.

How many patients will RASolute 304 (RVMD) enroll and which mutation does it target?

RASolute 304 is anticipated to enroll approximately 500 patients with pancreatic cancer harboring oncogenic RAS mutations.

What is the primary endpoint of the RASolute 304 trial (RVMD)?

The primary endpoint is disease-free survival comparing daraxonrasib to observation.

When was the first patient randomized in RASolute 304 (RVMD)?

The first patient was randomized on Dec 18, 2025.

How many Phase 3 trials is daraxonrasib being evaluated in (RVMD)?

Daraxonrasib is currently being evaluated in four global Phase 3 trials, including three in PDAC and one in RAS mutant non-small cell lung cancer.