On November 4, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers, reported its financial results for the quarter ended September 30, 2026, and provided an update on corporate progress.
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"The U.S. approval and launch of RASONQUE marked a monumental step forward for eligible patients with pancreatic cancer and a transformational quarter for Revolution Medicines, and the CHMP opinion sets the stage for potential approval in the European Union," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "We are focused on delivering RASONQUE with urgency and supporting patients as they begin treatment while we rapidly scale our global commercialization capabilities in preparation for potential international approvals. We also continue to advance our broad, integrated portfolio of RAS(ON) inhibitors across common, difficult-to-treat RAS-addicted cancers."
Commercial Highlights
RASONQUE (daraxonrasib) U.S. Launch
On August 26, 2026, the U.S. Food and Drug Administration (FDA) approved RASONQUE (daraxonrasib), the company’s oral RAS(ON) multi-selective inhibitor, for adults with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Immediately following approval, the company launched RASONQUE in the U.S.
RASONQUE generated net product revenue of $197.6 million for the quarter ended September 30, 2026, reflecting approximately five weeks of commercial availability following FDA approval on August 26. From FDA approval through September 30, 2026, more than 5,000 unique patients received commercial RASONQUE in the U.S.
Initial net product revenue included patients transitioning from the U.S. Expanded Access Program (EAP), patients who had exhausted available treatment options and were awaiting an approved treatment option, and newly eligible patients initiating RASONQUE following its approval, as well as initial stocking of inventory into the channel. The EAP transition and initial cohort of waiting patients are finite early-launch dynamics, and third-quarter results should not be viewed as indicative of the launch’s longer-term trajectory.
Early physician engagement spanned academic cancer centers and community oncology practices. RASONQUE claims have been reimbursed across health plans collectively representing greater than 90% of U.S. PDAC covered lives while formal coverage policies continue to develop. The company’s field access and ON(Path)TM patient support services teams support benefits verification, coverage navigation, financial assistance and patient support.
The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines), which guide U.S. clinical practice, were updated to include RASONQUE as a Category 1 Preferred subsequent-therapy option for appropriate patients with locally advanced or metastatic pancreatic cancer, or with recurrent disease following prior systemic therapy. The NCCN Guidelines also list RASONQUE in treatment-naïve metastatic disease as "Useful in Certain Circumstances," with the applicable category linked to prescriber assessments of performance status. These guidelines do not change the FDA-approved indication.
Eligible patients with previously treated metastatic pancreatic cancer are receiving daraxonrasib through Global Named Patient Access (GNPA) in certain countries prior to local regulatory approval. Access follows physician-initiated, unsolicited requests and is subject to applicable local laws and regulations, and operational feasibility.
Positive CHMP Opinion Advances Path Toward Approval in the European Union
The company continues to build its global commercialization capabilities across priority European markets and Japan in preparation for potential international regulatory approvals.
In October, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending approval of daraxonrasib as a monotherapy indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, marking a major step toward bringing the medicine to eligible patients in the European Union.
The recommendation follows RASONQUE’s U.S. approval and is based on results from RASolute 302, the first Phase 3 trial in metastatic pancreatic cancer to demonstrate superior efficacy of a targeted medicine versus chemotherapy. The trial demonstrated an unprecedented survival benefit, with consistent benefit across the study population, providing a strong clinical foundation for European access and reimbursement discussions. The positive opinion follows an expedited phased review under the EMA’s Cancer Medicines Pathfinder project. A decision by the European Commission on the marketing application for RASONQUE is pending.
In parallel, Revolution Medicines is advancing its evidence package and preparing for country-specific pricing, reimbursement and access processes across European markets. Following potential European Commission approval, the timing of commercial availability will vary by country governed by the legal and regulatory frameworks within each country.
The company also continues commercial preparations in Japan, subject to regulatory approval.
Clinical Highlights
Pancreatic Adenocarcinoma (PDAC)
With RASONQUE’s U.S. approval establishing a foundation in metastatic pancreatic cancer, Revolution Medicines is advancing four additional global Phase 3 studies across first-line metastatic and adjuvant settings. This multi-asset strategy evaluates RAS(ON) inhibition as monotherapy, in combination with chemotherapy and through a novel RAS(ON) inhibitor doublet, with the aim of extending potential benefit to more patients and earlier stages of disease.
Daraxonrasib in PDAC
At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, the company presented additional exploratory subgroup analyses from the Phase 3 RASolute 302 trial as a late-breaking abstract. The analyses showed that RASONQUE consistently provided an overall survival (OS) benefit compared with chemotherapy across all evaluated RAS genotype subgroups among patients with previously treated metastatic PDAC, including those with no identified tumor RAS mutation. The OS benefit with RASONQUE was also maintained across preselected standard-of-care chemotherapy regimens and prior treatment settings, including early metastatic recurrence following perioperative therapy.
Longer-term follow-up from the ongoing Phase 1 trial evaluating daraxonrasib in combination with gemcitabine and nab-paclitaxel in treatment-naïve metastatic pancreatic cancer will be shared in a late-breaking oral presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium, building on findings previously presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026.
The company also announced that the FDA granted Breakthrough Therapy Designation (BTD) for the investigational combination of daraxonrasib with gemcitabine and nab-paclitaxel for the treatment of treatment-naïve metastatic pancreatic cancer. This marks the third BTD for daraxonrasib and fifth across the company’s portfolio of RAS(ON) inhibitors.
The company completed U.S. enrollment in RASolute 303, the global Phase 3 trial evaluating daraxonrasib as monotherapy or in combination with chemotherapy in treatment-naïve metastatic pancreatic cancer. Global enrollment is expected to be completed in the first half of 2027.
The company continues to advance RASolute 304, the global Phase 3 trial evaluating daraxonrasib in the adjuvant setting.
Zoldonrasib in PDAC
The FDA granted Orphan Drug Designation (ODD) to zoldonrasib, the company’s oral RAS(ON) G12D-selective covalent inhibitor, for the treatment of pancreatic cancer. This marks the fifth ODD across the company’s portfolio of RAS(ON) inhibitors.
The company announced it has begun treating patients in RASolute 309, the global Phase 3 trial evaluating the novel RAS(ON) inhibitor doublet of daraxonrasib plus zoldonrasib in patients with treatment-naïve metastatic RAS G12D pancreatic cancer.
The company continues to advance RASolute 305, the global Phase 3 trial evaluating zoldonrasib in combination with chemotherapy in treatment-naïve metastatic RAS G12D pancreatic cancer.
Non-Small Cell Lung Cancer (NSCLC)
Revolution Medicines continues to advance a broad RAS-targeted portfolio in NSCLC, with both clinical-stage RAS(ON) multi-selective and mutant-selective inhibitors designed to address a broad spectrum of RAS-driven malignancies. The clinical-stage portfolio includes mutant-selective inhibitors targeting RAS G12C, G12D and G12V, which together account for more than 70% of RAS mutant NSCLC.
Daraxonrasib in NSCLC
Development of daraxonrasib in previously treated RAS mutant NSCLC continues to advance. Global enrollment in RASolve 301, the Phase 3 trial evaluating daraxonrasib in this setting, is winding down with all sites expected to close enrollment by the end of November 2026, supporting an anticipated initial readout in 2027.
Previously reported Phase 1/2 clinical data evaluating daraxonrasib in RAS mutant NSCLC were published in The New England Journal of Medicine during the quarter.
The NCCN Guidelines were updated to include RASONQUE as a Category 2A available targeted agent for patients with metastatic NSCLC harboring KRAS G12, G13 or Q61 mutations. Daraxonrasib remains investigational for the treatment of NSCLC.
Zoldonrasib in NSCLC
Zoldonrasib continues to advance across multiple treatment settings in NSCLC. The company announced it has begun treating patients in RASolve 308, the global Phase 3 trial evaluating zoldonrasib in combination with pembrolizumab and platinum doublet chemotherapy in patients with treatment-naïve metastatic RAS G12D NSCLC.
Elironrasib in NSCLC
The company initiated RASolve 307, a global Phase 3 trial in patients with treatment-naïve metastatic RAS G12C NSCLC. The trial is evaluating elironrasib, the company’s oral, RAS(ON) G12C-selective covalent inhibitor, in combination with pembrolizumab and platinum doublet chemotherapy.
Colorectal Cancer (CRC)
The company is initiating a global, randomized Phase 3 trial, RASonate 312, evaluating the combination of zoldonrasib, cetuximab and FOLFOX/FOLFIRI in patients with treatment- naïve metastatic RAS G12D CRC compared with standard of care. The trial is based on strong initial clinical activity observed with the zoldonrasib combination regimen, including encouraging objective response rates and disease control rates, along with an acceptable safety and tolerability profile generally consistent with what would be expected for cetuximab and FOLFOX.
Under the companies’ existing agreement, BeOne Medicines is funding and conducting the trial on Revolution Medicines’ behalf. Revolution Medicines expects to provide a clinical data update from its earlier phase CRC studies along with the RASonate 312 trial design in the first half of 2027.
Early-Stage Programs
RMC-5127
The company continues enrollment in the ongoing first-in-human trial evaluating RMC-5127, its oral RAS(ON) G12V-selective, noncovalent inhibitor, and is nearing selection of a candidate recommended Phase 2 dose. The company expects to report initial clinical monotherapy data in 2027.
Innovative New Class of RAS(ON) Inhibitors
The company remains on track to initiate a first-in-human clinical trial evaluating RM-055, a representative of its novel class of mutant-targeted catalytic RAS(ON) inhibitors, in the fourth quarter of 2026.
Collaborations
The company’s development efforts continue to include ongoing clinical collaborations evaluating its RAS(ON) inhibitors in combination with other targeted therapies, including Summit Therapeutics’ PD-1/VEGF bispecific antibody and MTA-cooperative PRMT5 inhibitors from Tango Therapeutics and Bristol Myers Squibb (BMS).
Since its last quarterly update, the company announced the following new collaborations:
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In August, the company announced a multi-part collaboration with BeOne Medicines including a clinical development collaboration to explore combinations of its RAS(ON) inhibitors with select BeOne oncology assets, including the MTA-cooperative PRMT5 inhibitor BGB-58067 and the EGFR × MET × MET trispecific antibody BG-T187. Separately, the companies entered into a regional rights agreement granting BeOne exclusive development and commercialization rights to four clinical-stage RAS(ON) inhibitors in select Asian markets.
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In October, the company entered into clinical collaborations with BMS to evaluate pumitamig, an investigational PD-L1/VEGF bispecific immunomodulator jointly developed by BioNTech and BMS, in four planned early-stage combination study cohorts across Revolution Medicines’ RAS(ON) inhibitor portfolio.
Other Corporate Updates
In support of the company’s growing global commercialization capabilities, the company has continued to build its international leadership team, with country general managers now in place across key European markets, Canada and Japan, supported by regional leadership in Europe and the Japan and Asia-Pacific (JPAC) region.
Royalty Pharma Funding Arrangement
RASONQUE’s U.S. approval triggered the mandatory first debt tranche of $250 million under the company’s funding arrangement with Royalty Pharma. The company received the proceeds in October 2026, which are not included in the September 30, 2026 cash, cash equivalents and marketable securities balance.
RASONQUE’s U.S. approval also triggered an optional third royalty tranche of $250 million under the funding arrangement. Given its strong financial position, the company elected not to draw the optional third royalty financing tranche, which would have required incremental future royalty payments. Up to an additional $1 billion in committed capital remains available under the funding arrangement, subject to achievement of specified milestones. All remaining draws are optional and at the company’s election.
Financial Highlights
Third Quarter Results
Net Product Revenue: RASONQUE net product revenue was $197.6 million for the quarter ended September 30, 2026, reflecting approximately five weeks of commercial availability following U.S. FDA approval on August 26, 2026, and initial stocking of product in the channel.
Cash Position: Cash, cash equivalents and marketable securities were $3.7 billion as of September 30, 2026. This balance excludes the $250 million in proceeds received in October associated with the first mandatory debt tranche under the company’s Royalty Pharma funding arrangement.
Cost of Sales: Cost of sales was $0.3 million for the quarter ended September 30, 2026. Product sold during the quarter included inventory manufactured before FDA approval for which manufacturing costs were previously expensed to research and development. Accordingly, cost of sales for the quarter is not representative of normalized cost of sales.
R&D Expenses: Research and development expenses were $417.1 million for the quarter ended September 30, 2026 compared to $262.5 million for the quarter ended September 30, 2025. The increase was primarily driven by higher clinical trial and manufacturing expenses for RASONQUE, zoldonrasib and RMC-5127, increased personnel-related costs due to additional headcount, and higher stock-based compensation expense.
SG&A Expenses: Selling, general and administrative expenses were $153.3 million for the quarter ended September 30, 2026, compared to $52.8 million for the quarter ended September 30, 2025. The increase was primarily driven by higher personnel-related costs associated with additional headcount, higher commercial expenses due to the RASONQUE commercial launch, and higher stock-based compensation expense.
Net Loss: Net loss was $407.5 million for the quarter ended September 30, 2026, compared to net loss of $305.2 million for the quarter ended September 30, 2025. Net loss for the quarter ended September 30, 2026 included non-cash charges of $40.7 million related to a change in the fair value of warrants assumed as part of the company’s acquisition of EQRx, Inc.
Financial Guidance
Revolution Medicines is reiterating full-year 2026 GAAP operating expense guidance of $2.1 billion to $2.2 billion, including expected non-cash stock-based compensation expense of $270 million to $290 million.
Webcast
Revolution Medicines will host a webcast this afternoon, November 4, 2026, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.
About RASONQUE© (daraxonrasib)
RASONQUE (daraxonrasib) is an oral, RAS(ON) multi-selective, noncovalent, tri-complex inhibitor, approved by the U.S. FDA for the treatment of adult patients with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. RASONQUE is being investigated through a global Phase 3 registrational program in patients with PDAC and metastatic RAS mutant non-small cell lung cancer. Outside the U.S., RASONQUE is an investigational agent that has not been approved by any regulatory authority.
U.S. FDA APPROVED INDICATION
RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
IMPORTANT SAFETY INFORMATION FOR U.S. APPROVED INDICATION
RASONQUE is associated with the following Warnings and Precautions: Dermatologic and Soft Tissue Toxicity, Stomatitis and Oral Disorders, Diarrhea, Gastrointestinal Perforation, Interstitial Lung Disease (ILD)/Pneumonitis, and Embryo-Fetal Toxicity.
Serious adverse reactions occurred in 30% of patients treated with RASONQUE. Serious adverse reactions occurring in ≥ 2% of patients treated with RASONQUE were diarrhea (3.7%), pyrexia (3.3%), sepsis (2.9%), fatigue (2.1%), and hemorrhage (2.1%).
The most common (≥ 20%) adverse reactions in patients treated with RASONQUE were rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.
Please see U.S. Full Prescribing Information for RASONQUE
(Press release, Revolution Medicines, NOV 4, 2026, View Source [SID1234674179])