Revolution Medicines Begins Treating Patients in Phase 3 RASolute 303 Trial Evaluating Daraxonrasib as First Line Treatment for Patients with Metastatic Pancreatic Cancer

Rhea-AI Impact

(High)

Rhea-AI Sentiment

(Positive)

Rhea-AI Summary

Revolution Medicines (NASDAQ:RVMD) has begun treating patients in RASolute 303, a global Phase 3 trial of daraxonrasib for previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC).

The randomized, open-label study compares daraxonrasib as monotherapy and combined with gemcitabine plus nab-paclitaxel versus standard-of-care gemcitabine and nab-paclitaxel, enrolling patients irrespective of tumor RAS genotype. Primary endpoints are progression-free survival and overall survival. Daraxonrasib is being evaluated in four global Phase 3 registrational trials, including three in PDAC and one in NSCLC.

Positive

Phase 3 dosing started for daraxonrasib in metastatic PDAC
Global, randomized trial design testing monotherapy and combination arms
Primary endpoints: progression-free survival and overall survival
Enrollment irrespective of RAS genotype broadens patient eligibility
Daraxonrasib in four global Phase 3 registrational trials

Negative

Open-label design may increase potential assessment bias
No efficacy or safety results reported yet from RASolute 303
Primary endpoints (PFS and OS) imply potentially long follow-up

Key Figures

Phase 3 trials (daraxonrasib): Four global Phase 3 trials Planned enrollment: Approximately 500 patients Objective response rate: 35% +5 more

8 metrics

Phase 3 trials (daraxonrasib) Four global Phase 3 trials Daraxonrasib programs in PDAC and NSCLC noted in article

Planned enrollment Approximately 500 patients RASolute 304 resectable PDAC Phase 3 trial

Objective response rate 35% Second-line daraxonrasib in RAS G12X PDAC (RASolute 303-supporting data)

Median overall survival 13.1 months Second-line daraxonrasib in RAS G12X PDAC

First-line monotherapy ORR 47% Daraxonrasib monotherapy in first-line metastatic PDAC

First-line monotherapy DCR 89% Disease control rate in first-line metastatic PDAC

Combination ORR 55% Daraxonrasib + GnP in first-line metastatic PDAC

Combination DCR 90% Disease control rate for daraxonrasib + GnP in metastatic PDAC

Market Reality Check

Price: $98.64 Vol: Volume 2,183,516 vs 20-da...

normal vol

$98.64 Last Close

Volume Volume 2,183,516 vs 20-day avg 1,938,779 (relative volume 1.13). normal

Technical Price $98.64 trades above 200-day MA of $66.74, 20.76% below 52-week high $124.49 and 238.16% above 52-week low $29.17.

Peers on Argus

RVMD gained 1.43% while close peers showed small, mixed moves (e.g., BPMC +0.09%...

RVMD gained 1.43% while close peers showed small, mixed moves (e.g., BPMC +0.09%, VRNA +0.06%, MDGL -0.28%, MRNA -3.12%, ROIV -1.03%). No coordinated sector momentum flagged.

Previous Clinical trial Reports

5 past events · Latest: Jan 29 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 29	First-in-human dosing	Positive	+0.9%	First patient dosed in RMC-5127-001 RAS(ON) G12V-selective trial.
Dec 18	Phase 3 PDAC start	Positive	-1.0%	First patient randomized in RASolute 304 Phase 3 PDAC adjuvant trial.
Oct 27	Orphan designation	Positive	+6.4%	FDA Orphan Drug Designation for daraxonrasib in pancreatic cancer.
Sep 10	Positive PDAC data	Positive	+14.3%	New daraxonrasib PDAC data supporting initiation of RASolute 303 Phase 3.
May 14	Phase 3 NSCLC start	Positive	-1.2%	First patient dosed in RASolve 301 Phase 3 NSCLC trial of daraxonrasib.

Pattern Detected

Clinical trial milestones have often produced positive moves, but with several negative or muted reactions, indicating mixed consistency in how trial updates translate into price action.

Recent Company History

Over the past year, clinical developments have focused on expanding RAS(ON) inhibition across pancreatic and lung cancers. Key steps included orphan drug designation for daraxonrasib in pancreatic cancer on October 27, 2025, initiation of Phase 3 trials RASolute 303 and 304 in pancreatic ductal adenocarcinoma, and RASolve 301 in RAS mutant NSCLC, plus first dosing in the RMC-5127-001 trial. Today’s launch of treatment in the global Phase 3 RASolute 303 trial continues this progression into first-line metastatic PDAC.

Historical Comparison

+3.9% avg move · Clinical-trial headlines have moved RVMD by an average of 3.89%. Today’s Phase 3 RASolute 303 treatm...

clinical trial

+3.9%

Average Historical Move clinical trial

Clinical-trial headlines have moved RVMD by an average of 3.89%. Today’s Phase 3 RASolute 303 treatment start and its 1.43% gain sit below that typical reaction range.

Clinical news shows a steady build-out of the RAS(ON) pipeline: from early RMC-5127 first-in-human work, to orphan designation and multiple Phase 3 trials for daraxonrasib in metastatic and resectable PDAC, plus the RASolve 301 NSCLC program, now extending to first-line metastatic PDAC in RASolute 303.

Market Pulse Summary

This announcement marks the start of patient treatment in RASolute 303, a global Phase 3 trial of da...

Analysis

This announcement marks the start of patient treatment in RASolute 303, a global Phase 3 trial of daraxonrasib as first-line therapy for metastatic PDAC, with primary endpoints of progression-free and overall survival. It builds on earlier data showing objective response rates up to 55% and disease control rates up to 90% in PDAC, as well as multiple ongoing Phase 3 programs. Investors may watch enrollment progress, safety findings, and eventual efficacy readouts across daraxonrasib’s four Phase 3 trials for signals of long-term impact.

Key Terms

pancreatic ductal adenocarcinoma, pdac, progression-free survival, overall survival, +4 more

8 terms

pancreatic ductal adenocarcinoma medical

"previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC), a disease..."

A fast-growing cancer that starts in the cells lining the pancreas’ small ducts; it is the most common and aggressive form of pancreatic cancer. It matters to investors because its severity and limited treatment options drive high unmet medical need, large potential markets for effective drugs or diagnostics, and strong sensitivity of company valuations to clinical trial results, regulatory approvals, or changes in treatment guidelines—similar to how fixing a main leak can prevent major damage in a building.

pdac medical

"previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC), a disease..."

PDAC stands for pancreatic ductal adenocarcinoma, the most common and aggressive form of pancreatic cancer that starts in the pancreas’s duct cells. It matters to investors because PDAC represents a large unmet medical need with high patient mortality, driving intense drug development, clinical trial activity and potential regulatory milestones—like a critical, hard-to-fix engine part whose failure creates urgent demand for effective solutions, affecting a company’s valuation and risk profile.

progression-free survival medical

"The primary endpoints are progression-free survival and overall survival."

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"The primary endpoints are progression-free survival and overall survival."

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.

patient reported outcomes medical

"Key secondary endpoints include ... safety and tolerability, and patient reported outcomes."

Patient reported outcomes are measurements of a patient’s own assessment of their symptoms, daily functioning, or quality of life collected directly from the patient via surveys, diaries, or apps rather than from doctors or tests. They matter to investors because regulators, payers and clinicians use these firsthand reports to judge whether a treatment delivers real-world benefit; strong patient-reported results can improve a therapy’s chances of approval, reimbursement and market adoption, much like positive customer reviews boost product sales.

gemcitabine medical

"in combination with gemcitabine and nab-paclitaxel versus standard-of-care..."

Gemcitabine is a chemotherapy drug that works by interfering with cancer cells’ ability to copy their DNA, which slows or stops tumor growth. Investors watch it because clinical trial results, regulatory approvals, patent status, or manufacturing and supply issues for a widely used cancer medicine can materially affect a drugmaker’s sales, partnerships, and stock value—think of it as a key product whose market performance can move a company.

nab-paclitaxel medical

"in combination with gemcitabine and nab-paclitaxel versus standard-of-care..."

A chemotherapy drug formulation in which the anti-cancer agent paclitaxel is bound to human albumin protein particles to improve delivery into tumors and avoid harsh solvent ingredients used in older versions. Investors pay attention because clinical trial results, regulatory approvals, patent or licensing status, and manufacturing capacity for this specialized formulation can drive sales, pricing power and a company’s future revenue potential — like a better-packaged product that reaches customers more effectively.

non-small cell lung cancer medical

"one in patients with non-small cell lung cancer (NSCLC)."

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.

AI-generated analysis. Not financial advice.

04/02/2026 - 08:00 AM

REDWOOD CITY, Calif., April 02, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that it has begun treating patients in RASolute 303, a global Phase 3 clinical trial evaluating daraxonrasib as monotherapy and in combination with chemotherapy in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC), a disease predominantly driven by oncogenic RAS variants. RASolute 303 is designed to enroll patients irrespective of tumor RAS genotype.

“Starting treatment of study participants in the RASolute 303 trial represents an important milestone for our daraxonrasib program and for patients with metastatic pancreatic cancer, a disease with substantial unmet medical need,” said Alan Sandler, M.D., chief development officer of Revolution Medicines. “In this trial, we are testing two biologically rational approaches—daraxonrasib as monotherapy and daraxonrasib in combination with chemotherapy—as two distinct, promising strategies to potentially improve patient outcomes. This trial underscores our commitment to advancing RAS(ON) inhibition into earlier lines of therapy, where we believe it can deliver significant benefit.”

RASolute 303 (NCT07491445) is a global, randomized, open-label Phase 3 trial evaluating daraxonrasib as monotherapy or in combination with gemcitabine and nab-paclitaxel versus standard-of-care gemcitabine and nab-paclitaxel in patients with previously untreated metastatic PDAC. In this trial, the company is enrolling patients who have not received prior systemic therapy for metastatic disease. The primary endpoints are progression-free survival and overall survival. Key secondary endpoints include additional measures of antitumor activity, safety and tolerability, and patient reported outcomes.

Daraxonrasib is currently being evaluated in four global Phase 3 registrational trials, including three trials in patients with PDAC and one in patients with non-small cell lung cancer (NSCLC).

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 are 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-driven malignancy 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 broad range of cancers driven by oncogenic RAS, including PDAC, NSCLC and colorectal cancer. Daraxonrasib suppresses RAS signaling by blocking the interaction of wild-type and mutant RAS(ON) with its downstream effectors.

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 company’s ability to improve patient outcomes or advance RAS(ON) inhibition into earlier lines of therapy. 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’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 25, 2026, 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 February 2026.

FAQ

What is RASolute 303 and what does RVMD (RVMD) aim to study?

RASolute 303 is a global Phase 3 trial testing daraxonrasib as monotherapy and combined with chemotherapy. According to the company, it compares daraxonrasib (alone or with gemcitabine and nab-paclitaxel) versus standard gemcitabine plus nab-paclitaxel in first-line metastatic PDAC.

When did Revolution Medicines (RVMD) begin treating patients in RASolute 303?

Revolution Medicines began treating patients in RASolute 303 on April 2, 2026. According to the company, dosing of study participants marks the trial's operational start for this global Phase 3 program.

What are the primary endpoints of the RASolute 303 trial (RVMD)?

The primary endpoints are progression-free survival and overall survival. According to the company, these endpoints will measure whether daraxonrasib (alone or with chemotherapy) improves time to progression and overall patient survival.

Who is eligible for enrollment in RASolute 303 (RVMD)?

Patients with previously untreated metastatic pancreatic ductal adenocarcinoma are eligible, regardless of tumor RAS genotype. According to the company, the trial enrolls patients who have not received prior systemic therapy for metastatic disease.

How many Phase 3 registrational trials is daraxonrasib currently involved in for RVMD?

Daraxonrasib is currently being evaluated in four global Phase 3 registrational trials. According to the company, three of these trials are in PDAC and one is in non-small cell lung cancer.

Revolution Medicines Begins Treating Patients in Phase 3 RASolute 303 Trial Evaluating Daraxonrasib as First Line Treatment for Patients with Metastatic Pancreatic Cancer