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Expanding on the unprecedented final results previously reported from the Phase 3 RASolute 302 trial, the exploratory subgroup analyses showed RASONQUE consistently provided an overall survival benefit compared with chemotherapy across key subgroups, including patients with no identified tumor RAS mutation​Findings presented as late-breaking abstract during Proffered Paper session REDWOOD CITY, Calif., Oct. 23, 2026 (GLOBE NEWSWIRE) -- 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, today announced that exploratory subgroup analyses from the Phase 3 RASolute 302 trial were presented as a late-breaking abstract at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain. The analyses showed that RASONQUE (daraxonrasib) consistently provided an overall survival (OS) benefit compared with chemotherapy across all evaluated RAS genotype subgroups among patients with previously treated metastatic pancreatic adenocarcinoma (PDAC), including those with no identified tumor RAS mutation. The OS benefit with RASONQUE was also maintained across preselected standard-of-care (SOC) chemotherapy regimens and prior treatment settings, including early metastatic recurrence following perioperative therapy.

“For people living with metastatic pancreatic cancer, progression after initial treatment can be devastating, with limited options and a poor prognosis,” said Zev A. Wainberg, M.D., Professor of Medicine at UCLA and co-director of the UCLA GI Oncology Program, RASolute 302 investigator and presenter of the data at ESMO. “The analysis presented at ESMO reinforces the unprecedented and statistically significant survival benefit of daraxonrasib observed in the overall study population of the RASolute 302 trial. The overall survival benefit was seen consistently across all evaluated tumor RAS profiles, underscoring the potential of daraxonrasib to benefit the broad population of patients with this devastating disease.” ​

In the RASolute 302 trial, patients were randomized to receive either RASONQUE 300 mg once daily (n=248) or investigator’s choice of standard chemotherapy (n=252). These exploratory subgroup analyses were derived from the prespecified primary analysis of RASolute 302, conducted at the February 10, 2026 data cutoff, which had a median follow-up of 8.5 months. In the previously reported primary analysis, median OS was 13.2 months with RASONQUE versus 6.7 months with chemotherapy (hazard ratio [HR] 0.40; 95% confidence interval [CI]: 0.30–0.53). For these exploratory analyses, across the RAS subgroups evaluated, the OS HR was 0.49 (95% CI: 0.33–0.74) for G12D mutations, 0.32 (95% CI: 0.19–0.54) for G12V mutations, 0.61 (95% CI: 0.29–1.30) for G12R mutations, 0.37 (95% CI: 0.09–1.44) for RAS Q61 mutations, and 0.43 (95% CI: 0.09–1.98) for tumors with no identified RAS mutation.

The analyses also showed a consistent OS benefit with RASONQUE across preselected SOC chemotherapy regimens, including gemcitabine plus nab-paclitaxel (GnP; HR 0.45; 95% CI: 0.32–0.65), pooled modified FOLFIRINOX/FOLFOX (HR 0.46; 95% CI: 0.23–0.95) and nanoliposomal irinotecan plus fluorouracil and leucovorin (NAL-IRI + 5-FU/LV; HR 0.32; 95% CI: 0.18–0.58). ​

The OS improvement was also seen among patients treated with RASONQUE compared with chemotherapy across prior treatment settings, including metastatic disease diagnosed less than six months after the last dose of neoadjuvant or adjuvant therapy (HR 0.36; 95% CI: 0.17–0.75) and one prior line of therapy for metastatic disease (HR 0.43; 95% CI: 0.32–0.58).​

“These exploratory analyses across key subgroups from RASolute 302 reinforce RASONQUE as a potential new standard of care for eligible adults with metastatic pancreatic adenocarcinoma,” said Alan Sandler, M.D., chief development officer of Revolution Medicines. “They also support our broader clinical development program, which is evaluating targeted approaches across RAS variants and treatment settings with the goal of changing the treatment paradigm in RAS-addicted cancers where there is a significant unmet medical need. With RASONQUE approved in the United States, the European Medicines Agency’s Committee for Medicinal Products for Human Use recent positive opinion and regulatory reviews underway in other countries, we remain committed to expanding access to RASONQUE for eligible patients globally.”

The presentation (LBA82), titled “Daraxonrasib, a RAS(ON) multi-selective inhibitor vs chemotherapy in previously treated metastatic pancreatic adenocarcinoma (mPDAC): Additional subgroup analyses from the Phase 3 RASolute 302 study,” was delivered by Dr. Wainberg during the Proffered Paper 1: Gastrointestinal Tumour, Upper Digestive session on October 23, 2026, at the ESMO Congress in Madrid, Spain.​ The primary analysis from RASolute 302 was presented at the 2026 American Society of Clinical Oncology Annual Meeting with simultaneous publication in The New England Journal of Medicine. 

About Pancreatic Adenocarcinoma

Pancreatic adenocarcinoma, or PDAC, is the most common form of pancreatic cancer and among the most challenging malignancies. RAS, a key growth control switch in human cells, is the main driver of pancreatic cancer, which is characterized by excessive RAS signaling. Each year, approximately 500,000 people globally are diagnosed with PDAC and it is the seventh leading cause of cancer-related deaths worldwide.1,2
​
Because early-stage pancreatic cancer often causes few or no symptoms, approximately 80% of patients are diagnosed after the disease has spread, when treatment options are more limited.3 For patients with metastatic PDAC, the five-year relative survival rate is approximately 3% worldwide.4

About the RASolute 302 Clinical Trial

RASolute 302 (NCT06625320) was a global, randomized Phase 3 registrational clinical trial designed to evaluate the efficacy and safety of RASONQUE as a monotherapy in patients with previously treated metastatic pancreatic adenocarcinoma (PDAC). In the trial, patients were randomized to receive either an oral dose of 300 mg RASONQUE once daily or investigator’s choice of four different cytotoxic chemotherapy regimens, which represented standard of care across the globe. The trial enrolled patients with metastatic PDAC with RAS G12 mutations (such as G12D, G12V, and G12R), RAS G13 or Q61 mutations, as well as patients with no identified tumor RAS mutations.​

The primary endpoints of the RASolute 302 trial were progression-free survival (PFS), as assessed by a Blinded Independent Central Review according to RECIST 1.1, and overall survival (OS) in patients with tumors harboring RAS G12 mutations. Secondary endpoints included PFS and OS in all enrolled patients (the intent-to-treat population) encompassing patients with and without identified tumor RAS mutations, as well as objective response rate, duration of response, and patient-reported quality of life.​

About RASONQUE™ (daraxonrasib)

RASONQUE (daraxonrasib) is an oral, RAS(ON) multi-selective, noncovalent, tri-complex inhibitor (TCI), 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.5 RASONQUE is being investigated through a global Phase 3 registrational program in patients with PDAC and metastatic RAS mutant non-small cell lung cancer (NSCLC). Outside the U.S., RASONQUE is an investigational agent that has not been approved by any regulatory authority.​

U.S. 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.

U.S. IMPORTANT SAFETY INFORMATION

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.

U.S. WARNINGS AND PRECAUTIONS

Dermatologic and Soft Tissue Toxicity
RASONQUE can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, rash, pruritus, paronychia, dry skin, and skin fissures. In clinical trials of patients with pancreatic adenocarcinoma, dermatologic toxicity occurred in 86% of patients treated with RASONQUE, of which 10% were Grade 3.

Monitor patients who develop dermatologic or soft tissue toxicities while receiving RASONQUE. Initiate prophylactic measures (e.g., topical corticosteroids, emollient creams, sunscreen, oral antibiotics) prior to the first dose of RASONQUE to reduce the risk of moderate to severe dermatologic reactions. Advise patients to limit sun exposure while taking RASONQUE. Initiate supportive measures (e.g., oral corticosteroids) as clinically indicated, and consider dermatologic consultation. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.

Stomatitis and Oral Disorders

RASONQUE can cause stomatitis, including mouth ulcers and oral mucositis. In clinical trials of patients with pancreatic adenocarcinoma, stomatitis occurred in 57% of patients, of which 9% were Grade 3.
Monitor patients for signs and symptoms of stomatitis while receiving RASONQUE. Initiate a steroid-containing mouthwash for treatment of stomatitis and administer other topical treatments (e.g., chlorhexidine mouthwash, 2% lidocaine viscous) as clinically indicated. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.

Diarrhea

RASONQUE can cause diarrhea. In clinical trials of patients with pancreatic adenocarcinoma, diarrhea occurred in 63% of patients, of which 6% were Grade 3.

If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.

Gastrointestinal Perforation

RASONQUE can cause gastrointestinal perforation. In clinical trials of patients with pancreatic adenocarcinoma, gastrointestinal perforation occurred in 0.9% of patients treated with RASONQUE, of which 0.5% were Grade 3, one event was Grade 4, and one event was fatal.

Monitor patients for gastrointestinal perforation. Withhold RASONQUE if gastrointestinal perforation is suspected. Reduce the dose or permanently discontinue RASONQUE if no other potential causes of gastrointestinal perforation are identified.

Interstitial Lung Disease (ILD)/Pneumonitis

RASONQUE can cause interstitial lung disease or pneumonitis. In clinical trials of patients with pancreatic adenocarcinoma, ILD/pneumonitis occurred in 2.4% of patients treated with RASONQUE, of which 0.9% were Grade 3, and one event was fatal.

Monitor patients for new or worsening pulmonary symptoms. Withhold RASONQUE if ILD/pneumonitis is suspected. Reduce the dose or permanently discontinue RASONQUE if no other potential causes of ILD/pneumonitis are identified.

Embryo-Fetal Toxicity

Based on findings in animals, RASONQUE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose.

ADVERSE REACTIONS

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%).

Adverse reactions leading to permanent discontinuation of RASONQUE occurred in 2.9% of patients, including two patients who discontinued due to rash (0.8%).

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.

DRUG INTERACTIONS

Strong CYP3A Inhibitors with P-gp Inhibition: Avoid concomitant use.Strong CYP3A Inhibitors without P-gp Inhibition: Reduce RASONQUE dosage.Moderate CYP3A Inhibitors with or without P-gp Inhibition: Reduce RASONQUE dosage.P-gp Inhibitors: Reduce RASONQUE dosage.Cyclosporine A: Avoid concomitant use.Strong CYP3A Inducers: Avoid concomitant use. Increase RASONQUE dosage if concomitant use cannot be avoided.Moderate CYP3A Inducers: Increase RASONQUE dosage.P-gp Substrates: Take at least 4 hours apart from RASONQUE.
PROPHYLACTIC MEASURES
When initiating RASONQUE and throughout treatment, prophylactic and concomitant medications are recommended to reduce the risk of dermatologic reactions:

administer a topical corticosteroid (applied to the face and chest) and emollient creamsadvise patients to limit sun exposure and use broad-spectrum sunscreen (SPF 30 or higher)consider prophylactic oral antibiotics (e.g., doxycycline or minocycline)
Please see U.S. Full Prescribing Information for RASONQUE

About Revolution Medicines, Inc.

Revolution Medicines is a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. For more information, visit www.revmed.com and follow Revolution Medicines on LinkedIn, X (Twitter) and Instagram.

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 broad potential of RAS(ON) inhibition; the interpretation, significance and implications of the subgroup analyses and other data from the RASolute 302 trial; the potential of RASONQUE to become a standard of care or to change the treatment paradigm in pancreatic cancer or other RAS-addicted cancers; treatment practices; the company’s regulatory interactions and plans, including the timing and outcome of the European Commission’s decision following the CHMP positive opinion and of regulatory reviews in other jurisdictions; the commercialization, market acceptance and potential label expansion of RASONQUE; the company’s broader clinical development program; and progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of RASONQUE and the company's product candidates being studied.​

Forward-looking statements are typically, but not always, identified by the use of words such as "aims," "anticipate," "believe," "estimate," "expect," "plan," "potential," "project," "up to," "will" 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' development stages, the process of designing and conducting preclinical and clinical trials, 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 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 5, 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 Contacts 

Media
[email protected]

Investors
[email protected] 

References

1 Park W, Chawla A, O'Reilly EM. Pancreatic cancer: A review. JAMA. 2021;326(9):851-862. doi:10.1001/jama.2021.13027
2 González-López J, Bauza ME, Pérez-Rojas J, et al. Pancreatic adenocarcinoma: Diagnosis by ultrasound-guided fine-needle aspiration—cyto-histological correlation and experience at a multidisciplinary tertiary reference center. Diagn Cytopathol. 2026;54(6):403-416. doi:10.1002/dc.70097
3 Rahib L, Coffin T, Kenner B. Factors driving pancreatic cancer survival rates. Pancreas. 2025;54(6):e530-e536. doi:10.1097/MPA.0000000000002489
4 Levine JM, Rompen IF, Franco JC, et al. The impact of metastatic sites on survival rates and predictors of extended survival in patients with metastatic pancreatic cancer. Pancreatology. 2024;24(6):887-893. doi:10.1016/j.pan.2024.06.004
5 RASONQUE (daraxonrasib) Prescribing Information. Redwood City, CA: Revolution Medicines, Inc.; August 2026.

Recommendation based on results from Phase 3 RASolute 302 trial, which demonstrated a 60% reduction in risk of death compared with chemotherapy in the overall study population with statistically significant and clinically meaningful improvements across all primary and key secondary endpoints, regardless of tumor RAS mutation statusPositive CHMP opinion follows an expedited phased review of RASONQUE under the EMA’s Cancer Medicines Pathfinder project based on its potential to address a high unmet medical need REDWOOD CITY, Calif., Oct. 15, 2026 (GLOBE NEWSWIRE) -- 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, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of RASONQUE (daraxonrasib) once-daily oral tablets as a monotherapy indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. If approved by the European Commission (EC), RASONQUE would provide the first broad RAS-targeted treatment option in the European Union for adults with metastatic pancreatic adenocarcinoma.

“Today’s positive CHMP opinion marks a major step toward making RASONQUE available to eligible adults with metastatic pancreatic cancer in the European Union,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “RASONQUE is an oral medicine designed to address RAS, the key driver of pancreatic cancer, and unprecedented results from the Phase 3 RASolute 302 trial demonstrated its potential to benefit patients with this devastating disease. Its expedited review under the EMA’s Cancer Medicines Pathfinder project highlights how innovative regulatory pathways may help bring promising medicines to patients sooner. We look forward to the EC’s consideration of this CHMP positive opinion as we continue to work with regulatory authorities around the world to pursue additional approvals and broaden access to RASONQUE.”

RASolute 302: Phase 3 Clinical Trial Results Supporting Positive CHMP Opinion

The positive CHMP opinion is based on results from RASolute 302, a global, randomized Phase 3 trial evaluating RASONQUE versus investigator’s choice of cytotoxic chemotherapy in patients with previously treated metastatic PDAC. The trial met all primary and key secondary endpoints in both the RAS G12 mutant population and the overall intent-to-treat (ITT) population, which included patients with or without an identified tumor RAS mutation.

The primary analysis from RASolute 302 was presented at the 2026 American Society of Clinical Oncology Annual Meeting with simultaneous publication in The New England Journal of Medicine. In the ITT population, RASONQUE reduced the risk of death by 60% compared with chemotherapy, with a hazard ratio (HR) of 0.40 (95% confidence interval [CI]: 0.30–0.53; p<0.0001). The median overall survival (OS) was 13.2 months (95% CI: 10.0–NE) with RASONQUE compared to 6.7 months (95% CI: 5.8–8.0) for chemotherapy. RASONQUE also showed significant improvements in progression-free survival (PFS) with an HR of 0.49 (95% CI: 0.38–0.64; p<0.0001). The median PFS was 7.2 months (95% CI: 5.7–7.5) with RASONQUE compared to 3.6 months (95% CI: 2.9–4.2) with chemotherapy. Results were generally consistent in the RAS G12 population. A subsequent ad hoc OS analysis showed the median OS was 12.4 months with RASONQUE compared to 6.7 months for chemotherapy [HR: 0.49 (95% CI 0.39, 0.62)], which was generally consistent with the prespecified primary analysis.

The most common adverse reactions in patients treated with RASONQUE were diarrhea (63.1%), dermatitis acneiform (62.4%), stomatitis (55.5%), nausea (50.8%), vomiting (41.6%) and fatigue (33.2%).

Once granted by the EC, the centralized marketing authorization will be valid in all EU member states, as well as in the European Economic Area (EEA) countries Iceland, Norway and Liechtenstein; marketing authorization by the EC is not applicable in the United Kingdom or Switzerland, which have separate processes for considering new drug applications.

This CHMP Positive Opinion follows the approval of RASONQUE by U.S. Food and Drug Administration (FDA) on August 26, 2026.

About Pancreatic Adenocarcinoma

Pancreatic adenocarcinoma, or PDAC, is the most common form of pancreatic cancer and among the most lethal malignancies, frequently with a late diagnosis, aggressive biology, and limited responsiveness to available treatments. RAS, a key growth control switch in human cells, is the main driver of pancreatic cancer, which is characterized by excessive RAS signaling. Approximately 147,000 people are diagnosed with pancreatic cancer in Europe each year, and the five-year survival rate remains below 10%.1,2 Because early-stage pancreatic cancer often causes few or no symptoms, approximately 80% of patients are diagnosed after the disease has spread, when treatment options are more limited.3

About RASONQUETM (daraxonrasib)

RASONQUE (daraxonrasib) is an oral, RAS(ON) multi-selective, noncovalent, tri-complex inhibitor (TCI), approved by the U.S. FDA for the treatment of adult patients with metastatic PDAC who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.4 RASONQUE is being investigated through a global Phase 3 registrational program in patients with PDAC and metastatic RAS mutant non-small cell lung cancer (NSCLC).

Outside the U.S., RASONQUE is an investigational agent that has not been approved by any regulatory authority. RASONQUE received orphan medicinal product designation for pancreatic cancer and high-priority status under EMA’s Cancer Medicines Pathfinder project based on its potential to address a significant unmet need.

U.S. 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.

U.S. IMPORTANT SAFETY INFORMATION

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.

U.S. WARNINGS AND PRECAUTIONS

Dermatologic and Soft Tissue Toxicity

RASONQUE can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, rash, pruritus, paronychia, dry skin, and skin fissures. In clinical trials of patients with pancreatic adenocarcinoma, dermatologic toxicity occurred in 86% of patients treated with RASONQUE, of which 10% were Grade 3.

Monitor patients who develop dermatologic or soft tissue toxicities while receiving RASONQUE. Initiate prophylactic measures (e.g., topical corticosteroids, emollient creams, sunscreen, oral antibiotics) prior to the first dose of RASONQUE to reduce the risk of moderate to severe dermatologic reactions. Advise patients to limit sun exposure while taking RASONQUE. Initiate supportive measures (e.g., oral corticosteroids) as clinically indicated, and consider dermatologic consultation. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.

Stomatitis and Oral Disorders

RASONQUE can cause stomatitis, including mouth ulcers and oral mucositis. In clinical trials of patients with pancreatic adenocarcinoma, stomatitis occurred in 57% of patients, of which 9% were Grade 3.

Monitor patients for signs and symptoms of stomatitis while receiving RASONQUE. Initiate a steroid-containing mouthwash for treatment of stomatitis and administer other topical treatments (e.g., chlorhexidine mouthwash, 2% lidocaine viscous) as clinically indicated. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.

Diarrhea

RASONQUE can cause diarrhea. In clinical trials of patients with pancreatic adenocarcinoma, diarrhea occurred in 63% of patients, of which 6% were Grade 3.

If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.

Gastrointestinal Perforation

RASONQUE can cause gastrointestinal perforation. In clinical trials of patients with pancreatic adenocarcinoma, gastrointestinal perforation occurred in 0.9% of patients treated with RASONQUE, of which 0.5% were Grade 3, one event was Grade 4, and one event was fatal.

Monitor patients for gastrointestinal perforation. Withhold RASONQUE if gastrointestinal perforation is suspected. Reduce the dose or permanently discontinue RASONQUE if no other potential causes of gastrointestinal perforation are identified.

Interstitial Lung Disease (ILD)/Pneumonitis

RASONQUE can cause interstitial lung disease or pneumonitis. In clinical trials of patients with pancreatic adenocarcinoma, ILD/pneumonitis occurred in 2.4% of patients treated with RASONQUE, of which 0.9% were Grade 3, and one event was fatal.

Monitor patients for new or worsening pulmonary symptoms. Withhold RASONQUE if ILD/pneumonitis is suspected. Reduce the dose or permanently discontinue RASONQUE if no other potential causes of ILD/pneumonitis are identified.

Embryo-Fetal Toxicity

Based on findings in animals, RASONQUE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose.

ADVERSE REACTIONS

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%).

Adverse reactions leading to permanent discontinuation of RASONQUE occurred in 2.9% of patients, including two patients who discontinued due to rash (0.8%).

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.

DRUG INTERACTIONS

Strong CYP3A Inhibitors with P-gp Inhibition: Avoid concomitant use.Strong CYP3A Inhibitors without P-gp Inhibition: Reduce RASONQUE dosage.Moderate CYP3A Inhibitors with or without P-gp Inhibition: Reduce RASONQUE dosage.P-gp Inhibitors: Reduce RASONQUE dosage.Cyclosporine A: Avoid concomitant use.Strong CYP3A Inducers: Avoid concomitant use. Increase RASONQUE dosage if concomitant use cannot be avoided.Moderate CYP3A Inducers: Increase RASONQUE dosage.P-gp Substrates: Take at least 4 hours apart from RASONQUE.
  PROPHYLACTIC MEASURES

When initiating RASONQUE and throughout treatment, prophylactic and concomitant medications are recommended to reduce the risk of dermatologic reactions:

administer a topical corticosteroid (applied to the face and chest) and emollient creamsadvise patients to limit sun exposure and use broad-spectrum sunscreen (SPF 30 or higher)consider prophylactic oral antibiotics (e.g., doxycycline or minocycline) About Revolution Medicines, Inc.

Revolution Medicines is a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. For more information, visit www.revmed.com and follow Revolution Medicines on LinkedIn, X (Twitter) and Instagram.

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 broad potential of RAS(ON) inhibition; the review of the CHMP Opinion by the EC; the availability of RASONQUE in Europe and other jurisdictions; treatment practices; the company’s regulatory interactions; and reactions to RASONQUE; and progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company's candidates being studied.

Forward-looking statements are typically, but not always, identified by the use of words such as "aims," "anticipate," "believe," "estimate," "expect," "plan," "potential," "project," "up to," "will" 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' development stages, the process of designing and conducting preclinical and clinical trials, 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 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 5, 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 Contacts 

Media
[email protected]  

Investors
[email protected] 

References

1 Hawksworth G, Hales J, Martinez F, et al. Pancreatic cancer trends in Europe: epidemiology and risk factors. Med Stud. 2019;35(2):164-171. doi:10.5114/ms.2019.86336
2 International Agency for Research on Cancer. Pancreas. Global Cancer Observatory. https://gco.iarc.who.int/today/en/fact-sheets-cancers/13/pancreas. Accessed September 2026. 
3 Rahib L, Coffin T, Kenner B. Factors driving pancreatic cancer survival rates. Pancreas. 2025;54(6):e530-e536. doi:10.1097/MPA.0000000000002489
4 RASONQUE (daraxonrasib) Prescribing Information. Redwood City, CA: Revolution Medicines, Inc.; August 2026.

Company receives third Breakthrough Therapy Designation for RASONQUE and fifth across its portfolio of RAS(ON) inhibitors, further highlighting its differentiated strategy for developing innovative medicines for patients with RAS-addicted cancers
REDWOOD CITY, Calif., Sept. 14, 2026 (GLOBE NEWSWIRE) -- 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, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to RASONQUE (daraxonrasib), the company’s RAS(ON) multi-selective inhibitor, for treatment-naïve metastatic pancreatic adenocarcinoma (PDAC) in combination with gemcitabine and nab-paclitaxel (GnP), a multiagent chemotherapy regimen widely used in treating patients with PDAC. RASONQUE was recently approved by the U.S. FDA for the treatment of adult patients with metastatic PDAC who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.

The Breakthrough Therapy Designation is based on data from patients with treatment-naïve RAS mutant metastatic PDAC who received RASONQUE in combination with GnP in the open-label, multicenter Phase 1/2 RMC-GI-102 trial. In this cohort, RASONQUE in combination with GnP showed encouraging preliminary antitumor activity and a manageable safety profile that was consistent with the known safety profiles previously observed for both RASONQUE and GnP. These data informed the design of RASolute 303, the ongoing global Phase 3 trial evaluating RASONQUE as monotherapy and in combination with GnP versus GnP alone in patients with previously untreated metastatic PDAC, independent of tumor RAS genotype. The use of RASONQUE in combination with chemotherapy for treatment-naïve metastatic PDAC remains investigational with safety and efficacy not yet established.

“This Breakthrough Therapy Designation underscores the significant unmet need among patients with previously untreated metastatic pancreatic adenocarcinoma and recognizes the importance of advancing new treatment options earlier in their treatment journey,” said Alan Sandler, M.D., chief development officer of Revolution Medicines. “RASONQUE monotherapy demonstrated compelling clinical benefit in the RASolute 302 trial, leading to FDA approval for patients with previously treated metastatic pancreatic adenocarcinoma or those who are not candidates for multiagent systemic therapy. Data from the RMC-GI-102 study have now shown the therapeutic potential of RASONQUE in combination with GnP, a commonly used multiagent systemic therapy, in treatment-naïve patients. Together with our other ongoing studies, these findings reflect our deep commitment to advancing a broad RAS(ON) approach for patients with some of the most difficult-to-treat cancers.”

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. Pursuant to FDA guidelines, the medicine needs to have shown preliminary clinical evidence that demonstrates substantial improvement on a clinically significant endpoint over available medicines.

About Pancreatic Adenocarcinoma (PDAC)
Pancreatic adenocarcinoma, or PDAC, is the most common form of pancreatic cancer and among the most challenging malignancies. Approximately 55,000 people are diagnosed with PDAC in the U.S. each year, and more than 50,000 die from the disease with current standard of care.1,2 Because early-stage pancreatic cancer often causes few or no symptoms, approximately 80% of patients are diagnosed after the disease has spread, when treatment options are more limited. For patients with metastatic PDAC, the five-year relative survival rate is approximately 3% in the U.S.3.4

About RASONQUETM (daraxonrasib)
RASONQUE (daraxonrasib) is an oral, RAS(ON) multi-selective, noncovalent, tri-complex inhibitor (TCI), 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.5 RASONQUE is being investigated through a global Phase 3 registrational program in patients with PDAC and metastatic RAS mutant non-small cell lung cancer (NSCLC). 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.

WARNINGS AND PRECAUTIONS

Dermatologic and Soft Tissue Toxicity
RASONQUE can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, rash, pruritus, paronychia, dry skin, and skin fissures. In clinical trials of patients with pancreatic adenocarcinoma, dermatologic toxicity occurred in 86% of patients treated with RASONQUE, of which 10% were Grade 3.

Monitor patients who develop dermatologic or soft tissue toxicities while receiving RASONQUE. Initiate prophylactic measures (e.g., topical corticosteroids, emollient creams, sunscreen, oral antibiotics) prior to the first dose of RASONQUE to reduce the risk of moderate to severe dermatologic reactions. Advise patients to limit sun exposure while taking RASONQUE. Initiate supportive measures (e.g., oral corticosteroids) as clinically indicated, and consider dermatologic consultation. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.

Stomatitis and Oral Disorders
RASONQUE can cause stomatitis, including mouth ulcers and oral mucositis. In clinical trials of patients with pancreatic adenocarcinoma, stomatitis occurred in 57% of patients, of which 9% were Grade 3.

Monitor patients for signs and symptoms of stomatitis while receiving RASONQUE. Initiate a steroid-containing mouthwash for treatment of stomatitis and administer other topical treatments (e.g., chlorhexidine mouthwash, 2% lidocaine viscous) as clinically indicated. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.

Diarrhea
RASONQUE can cause diarrhea. In clinical trials of patients with pancreatic adenocarcinoma, diarrhea occurred in 63% of patients, of which 6% were Grade 3.
If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity.

Gastrointestinal Perforation
RASONQUE can cause gastrointestinal perforation. In clinical trials of patients with pancreatic adenocarcinoma, gastrointestinal perforation occurred in 0.9% of patients treated with RASONQUE, of which 0.5% were Grade 3, one event was Grade 4, and one event was fatal.

Monitor patients for gastrointestinal perforation. Withhold RASONQUE if gastrointestinal perforation is suspected. Reduce the dose or permanently discontinue RASONQUE if no other potential causes of gastrointestinal perforation are identified.

Interstitial Lung Disease (ILD)/Pneumonitis
RASONQUE can cause interstitial lung disease or pneumonitis. In clinical trials of patients with pancreatic adenocarcinoma, ILD/pneumonitis occurred in 2.4% of patients treated with RASONQUE, of which 0.9% were Grade 3, and one event was fatal.

Monitor patients for new or worsening pulmonary symptoms. Withhold RASONQUE if ILD/pneumonitis is suspected. Reduce the dose or permanently discontinue RASONQUE if no other potential causes of ILD/pneumonitis are identified.

Embryo-Fetal Toxicity
Based on findings in animals, RASONQUE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose.

ADVERSE REACTIONS
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%).

Adverse reactions leading to permanent discontinuation of RASONQUE occurred in 2.9% of patients, including two patients who discontinued due to rash (0.8%).

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.

DRUG INTERACTIONS

Strong CYP3A Inhibitors with P-gp Inhibition: Avoid concomitant use.Strong CYP3A Inhibitors without P-gp Inhibition: Reduce RASONQUE dosage.Moderate CYP3A Inhibitors with or without P-gp Inhibition: Reduce RASONQUE dosage.P-gp Inhibitors: Reduce RASONQUE dosage.Cyclosporine A: Avoid concomitant use.Strong CYP3A Inducers: Avoid concomitant use. Increase RASONQUE dosage if concomitant use cannot be avoided.Moderate CYP3A Inducers: Increase RASONQUE dosage.P-gp Substrates: Take at least 4 hours apart from RASONQUE. PROPHYLACTIC MEASURES
When initiating RASONQUE and throughout treatment, prophylactic and concomitant medications are recommended to reduce the risk of dermatologic reactions:

administer a topical corticosteroid (applied to the face and chest) and emollient creams;advise patients to limit sun exposure and use broad-spectrum sunscreen (SPF 30 or higher); andconsider prophylactic oral antibiotics (e.g., doxycycline or minocycline).
Please see U.S. Full Prescribing Information for RASONQUE

About Revolution Medicines, Inc.
Revolution Medicines is a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. For more information, visit www.revmed.com and follow Revolution Medicines on LinkedIn, X (Twitter) and Instagram.

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 broad potential of RAS(ON) inhibition; treatment practices; the company’s regulatory interactions and the potential for Breakthrough Therapy Designation to expedite the development and review of new medicines; reactions to RASONQUE; and progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company's candidates being studied.

Forward-looking statements are typically, but not always, identified by the use of words such as "aims," "anticipate," "believe," "estimate," "expect," "plan," "potential," "project," "up to," "will" 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' development stages, the process of designing and conducting preclinical and clinical trials, 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 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 5, 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 Contacts 

Media
[email protected]  

Investors
[email protected] 

References

1 Oracle CancerMPact Patient Metrics, Stage IV newly incident + recurrent from earlier stages. Accessed July 2026.
2 Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.21820
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 September 2026.
5 RASONQUE (daraxonrasib) Prescribing Information. Redwood City, CA: Revolution Medicines, Inc.; August 2026.

Revolution Medicines NASDAQ: RVMD just landed one of the biggest wins in oncology this year, and the stock barely blinked. On Aug. 26, the FDA approved RASONQUE (daraxonrasib), the first broad RAS-targeted therapy for metastatic pancreatic cancer.

Revolution Medicines Today

RVMD

Revolution Medicines

$208.45 -2.42 (-1.15%)

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$39.17▼

$224.31$200.74

In the pivotal RASolute 302 trial, patients on RASONQUE nearly doubled their median overall survival compared to standard chemotherapy.

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This is a genuinely rare outcome in a disease that has resisted targeted therapy for decades.

By any normal standard, that's the kind of headline that sends a biotech stock soaring. Instead, RVMD shares traded roughly flat on the day of approval. The reason is simple: investors had already bought the rumor. 

RASolute 302's data was presented at oncology conferences months earlier, and the stock rallied 41% in a single day.

That gap between medical significance and market reaction is the real story here. It's also a lesson in how markets price information, not just outcomes.

The Science Is the Easy Part to BelieveRAS mutations drive more than 90% of pancreatic cancer cases, and for decades, RAS was considered "undruggable." Revolution Medicines built its entire platform around cracking that problem with its RAS(ON) tri-complex inhibitor technology, which binds the active, "on" state of the RAS protein rather than the inactive state that most earlier compounds targeted.

RASONQUE's approved label reflects just how far that platform has come. The drug is cleared for adults with metastatic pancreatic adenocarcinoma who've had at least one prior therapy, with or without an identified RAS mutation, and without requiring a companion diagnostic test.

That's a notably broad population for a targeted therapy. It's also a meaningful part of why oncologists are calling this a paradigm shift rather than an incremental improvement.

Priced in, Then Priced... Where, Exactly?Here's where the RVMD story gets more interesting than a simple "sell the news" narrative. Looking at the daily chart, RVMD isn't crashing; it's consolidating near all-time highs after an extraordinary run.

Shares recently traded around $210; down about 2% since the Aug. 26 announcement, but that's a rounding error against a stock that's up over 425% over the past 12 months and still trading near its 52-week high of $224.31. The 50-day moving average continues sloping upward, and MACD remains in bullish territory. It's what's known as a beautiful chart.

Analyst behavior tells a similar story. Since the approval, the Revolution Medicines analyst forecasts on MarketBeat show multiple firms have raised price targets, with Evercore having the most bullish target of $320. That kind of response shows that analysts had already modeled approval into estimates and are now recalibrating around what comes next: first-line expansion, additional tumor types, and peak sales assumptions.

The Competitive Picture Favors RVMD—For NowEli Lilly NYSE: LLY is often cited as RVMD's biggest threat in the RAS space, and it's a legitimate long-term competitor. But the comparison requires some precision. Lilly's lead RAS asset, olomorasib, is still in Phase 3 trials and targets only KRAS G12C-mutated tumors — a single mutation subtype. It isn't yet approved for pancreatic cancer at all.

RASONQUE, by contrast, launched with an approved label covering the broader RAS-mutant population, no diagnostic test required. Lilly does have earlier-stage G12D and pan-KRAS programs in development, along with rivals like Amgen NASDAQ: AMGN, Roche OTCMKTS: RHHBY, Merck NYSE: MRK, and Boehringer Ingelheim, all advancing their own RAS-pathway candidates.

The competitive field is real and will intensify. Today, though, Revolution Medicines holds the only broadly approved RAS-targeted therapy in pancreatic cancer, and that head start matters for capturing first-mover share in prescribing patterns.

The Bill for Building a Commercial BiotechThe one note of caution sits in the financials, not the clinical data. Revolution Medicines raised its 2026 GAAP operating expense guidance to a range of $2.1 billion to $2.2 billion as it scales manufacturing, clinical development, and commercial infrastructure simultaneously. Second-quarter net loss widened sharply to $644 million, up from $248 million a year earlier.

That's the cost of transitioning from a clinical-stage biotech to a commercial oncology company in real time. Furthermore, that kind of spending is not unusual for a first launch of this scale.

But it's worth noting that RASONQUE is currently doing the heavy lifting alone. The company's broader pipeline—additional RAS(ON) candidates across lung and colorectal cancer—is expanding, but nothing else appears close to its own approval in the near term. Investors betting on RVMD from here are effectively betting on one drug's commercial execution and label expansion, not a diversified product portfolio.

What Actually Moves This Stock From HereWith approval priced in and the "will it work" question answered, the next re-rating catalysts are execution-based rather than binary: first-line treatment expansion, additional trial readouts in lung and colorectal cancer, insurance reimbursement uptake at RASONQUE's $39,800 monthly list price, and evidence that the company can control spend as it scales commercially.

The medicine itself is a legitimate breakthrough for a disease for which patients have received almost nothing for decades. The stock's next move depends on something less dramatic: whether Revolution Medicines can turn a scientific win into a commercial one before cash burn outruns the launch.

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Key Takeaways RVMD reported a Q2 adjusted loss of $2.34 per share, wider than expectations.Revolution Medicines raised its 2026 operating expense outlook for the second time this year.RVMD advanced daraxonrasib and other RAS-targeted programs in late-stage development. Revolution Medicines (RVMD - Free Report) reported an adjusted loss of $2.34 per share in the second quarter of 2026, wider than the Zacks Consensus Estimate of a loss of $1.93.

The adjusted figure excluded a non-cash charge of $151 million tied to a change in the fair value of warrants assumed through the EQRx acquisition, which closed in 2023. Including this item, the reported loss was $3.06 per share. The company had incurred a loss of $1.31 per share in the year-ago quarter.

Currently, RVMD does not have any approved products in its portfolio. It has yet to generate revenues.

Shares of the company fell in after-market trading yesterday as investors did not react favorably to the wider-than-expected loss. The decline also reflected concerns over management’s decision to raise its operating expense guidance for the second time this year.

The stock has skyrocketed 148% year to date compared with the industry’s nearly 3% growth.

Image Source: Zacks Investment Research

RVMD’s Operating Expenses Increase SharplyResearch and development expenses surged 76% year over year to around $395 million. The increase reflected higher costs associated with clinical studies and manufacturing for the company’s pipeline candidates, along with increased employee-related expenses.

General and administrative expenses increased nearly 172% to more than $110 million. The increase was driven by higher personnel and stock-based compensation costs, increased commercial preparation activities and elevated administrative expenses.

Revolution Medicines Raises 2026 Expense View AgainThe company revised its operating expenses guidance for the second time this year. It expects the figure to be between $2.1 billion and $2.2 billion, up from the previous projection of $1.7 billion to $1.8 billion.

The updated forecast includes expected non-cash stock-based compensation expenses of $270 million to $290 million compared with the prior estimate of $260 million to $280 million.

Management intends to increase spending on commercial and clinical manufacturing, expand the company’s development programs and strengthen launch readiness in the United States and international markets.

RVMD Strengthens Cash PositionThe company ended June with cash, cash equivalents and marketable securities of $3.9 billion, up from $1.9 billion as of March 31, 2026.

The increase was primarily driven by $2.225 billion in gross proceeds from concurrent offerings of common stock and convertible senior notes completed in April. The quarter-end balance also included a $250 million payment received from Royalty Pharma in May.

Revolution Medicines Advances Daraxonrasib in Pancreatic CancerLast month, Revolution Medicines announced that the FDA accepted a regulatory filing for its lead candidate, daraxonrasib, in previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The filing is supported by data from the phase III RASolute 302 study, which showed statistically significant improvements in overall survival, progression-free survival and patient-reported quality of life versus chemotherapy.

The submission is being reviewed under the agency’s Commissioner’s National Priority Voucher (“CNPV”) pilot program, which significantly cuts down the review period to just one to two months. Revolution Medicines said its U.S. commercial infrastructure is ready to support a potential launch, including its sales organization, patient services platform, field access team and distribution network. The EMA also initiated a phased review under its Cancer Medicines Pathfinder project.

In the meantime, Revolution Medicines is evaluating daraxonrasib in two phase III studies — RASolute 303 and RASolute 304 — across earlier lines of treatment for PDAC. While RASolute 303 is assessing the drug in the first-line metastatic setting, RASolute 304 is evaluating its efficacy in the adjuvant setting.

Beyond PDAC, the company is also conducting the late-stage RASolve 301 study of daraxonrasib in patients with previously treated RAS-mutant non-small cell lung cancer (NSCLC). It expects to complete enrollment this year, supporting an initial readout in 2027.

RVMD Progresses Other Pipeline DrugsAlongside the earnings results, RVMD reported initial clinical data (as of the data cut-off of May 11, 2027) from separate studies on mutant-selective inhibitors, including elironrasib, which targets G12C, and zoldonrasib, which targets G12D.

Zoldonrasib combined with Merck’s (MRK - Free Report) Keytruda and platinum doublet chemotherapy produced an overall response rate (ORR) of 82% and a disease control rate (DCR) of 100% in evaluable patients with first-line RAS G12D NSCLC. Median follow-up was 3.4 months. Based on these results, the company recently started the phase III RASolve 308 study of this combination.

The elironrasib plus Keytruda and platinum doublet chemotherapy combination generated a confirmed ORR of 85% and a DCR of 97% in first-line RAS G12C NSCLC. At 8.7 months of median follow-up, 95% of patients remained progression-free at six months. Based on these findings, RVMD intends to start the phase III RASolve 307 study in the fourth quarter of 2026.

The company also announced that it recently started the phase III RASolute 309 study to evaluate the combination of zoldonrasib and daraxonrasib in previously treated RAS G12D PDAC. This initiation was supported by data from a phase I/II study, which showed that the regimen demonstrated compelling preliminary antitumor activity with a manageable safety and tolerability profile.

To further strengthen its position in the RAS-addicted cancer space, Revolution Medicines has entered into several agreements to accelerate the development of its pipeline. The company has established clinical collaborations with Bristol Myers (BMY - Free Report) , Summit Therapeutics (SMMT - Free Report) and Tango Therapeutics to evaluate combinations of its RAS inhibitors with their respective pipeline drugs.

RVMD’s Zacks RankThe stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

REDWOOD CITY, Calif., July 22, 2026 (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) accepted for review the company’s New Drug Application (NDA) for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

“The FDA’s acceptance of the daraxonrasib NDA is an important step in the regulatory review process and brings us closer to the possibility of offering patients a new targeted medicine for previously treated metastatic pancreatic cancer,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “Daraxonrasib is an oral targeted medicine designed to inhibit RAS, the main cause of pancreatic cancer, and the application is supported by unprecedented results from the Phase 3 RASolute 302 trial. These findings underscore the potential for daraxonrasib to become a new standard of care and to help define a new class of RAS‑targeted medicines for this disease. We look forward to continuing to work closely with the FDA as the agency reviews the application, and with other global regulatory authorities as we advance our efforts to bring daraxonrasib to patients as quickly as possible.”

The NDA is based on results from the global, randomized Phase 3 RASolute 302 trial, evaluating daraxonrasib versus standard of care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, with or without an identified tumor RAS mutation. The trial met all primary and key secondary endpoints, including unprecedented improvements in overall survival and progression-free survival. In addition, daraxonrasib exhibited a manageable safety profile and patients treated with daraxonrasib reported significantly delayed deterioration in cancer-related pain, overall global health status and quality of life, compared to those treated with chemotherapy. Results from the RASolute 302 trial were presented at the 2026 American Society of Clinical Oncology Annual Meeting with simultaneous publication in The New England Journal of Medicine.

Daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is designed to accelerate the review of medicines that address key national health priorities. The FDA previously granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic PDAC.

The Company recently announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has begun a phased review of daraxonrasib, allowing data to be evaluated as they become available before submission of a full marketing authorization application. Daraxonrasib has also received orphan medicine designation for the treatment of pancreatic cancer, and high-priority status under EMA’s Cancer Medicines Pathfinder project based on its potential to address a significant unmet need.

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 annually approximately 60,000 people will be diagnosed 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, most patients are diagnosed with pancreatic ductal adenocarcinoma (PDAC) at an advanced or metastatic stage. 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%.2,3

About Daraxonrasib

Daraxonrasib is an investigational, oral RAS(ON) multi-selective, noncovalent tri-complex inhibitor that works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors. It is designed to target cancers driven by a broad range of common RAS genotypes, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and colorectal cancer. Daraxonrasib is being advanced through a global Phase 3 registrational program comprising four trials, including the completed RASolute 302 trial and three additional trials in patients with PDAC and metastatic RAS mutant NSCLC.

About the RASolute 302 Clinical Trial

RASolute 302 (NCT06625320) is a global, randomized Phase 3 registrational clinical trial designed to evaluate the efficacy and safety of daraxonrasib as a monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). In the trial, patients were randomized to receive either an oral dose of 300 mg daraxonrasib once daily or investigator’s choice of four different cytotoxic chemotherapy regimens, which represent standard of care across the globe. The trial enrolled patients with metastatic PDAC harboring a wide range of RAS variants, including those with RAS G12 mutations (such as G12D, G12V, and G12R), as well as patients without an identified tumor RAS mutation (wild type).

The primary endpoints of the RASolute 302 trial were progression-free survival (PFS), as assessed by a Blinded Independent Central Review according to RECIST 1.1, and overall survival (OS) in patients with tumors harboring RAS G12 mutations. Secondary endpoints included PFS and OS in all enrolled patients (the intent-to-treat population) encompassing patients with and without identified tumor RAS mutations, as well as objective response rate, duration of response, and patient-reported quality of life.

About Revolution Medicines, Inc.

Revolution Medicines is a 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 the broad potential of RAS(ON) inhibition and the potential for a new class of RAS-targeted therapy to emerge; treatment practices for pancreatic cancer and the potential for daraxonrasib to become a standard of care; the company’s regulatory interactions; the company’s ability to bring daraxonrasib to patients; and progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied.

Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” "believe," "estimate," "expect," "plan," “potential,” “project,” “up to,” "will" 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’ development stages, the process of designing and conducting preclinical and clinical trials, 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 6, 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:
[email protected]
[email protected]   

References
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 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
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 July 2026.

Revolution Medicines (RVMD +0.92%) spent most of its history as a publicly traded company -- that's since 2020 -- trading for less than $50 a share. The company offers a new approach to oncology treatment, aiming for targets once thought to be "undruggable." In recent months, Revolution has clearly demonstrated the potential of its technology and is rapidly approaching the finish line. So, it's no surprise that investors have been taking notice.

In fact, they've taken so much notice that the stock price has soared nearly 140% this year. This is amid positive late-stage clinical trial results and optimism about potential revenue ahead. Considering the full picture and after its triple-digit gain, is this hot biotech stock still a buy? Let's find out.

Image source: Getty Images.

Making the "undruggable" protein "druggable" We'll start off by taking a look at Revolution's technology and pipeline progress. The company focuses on treating cancers linked to the activity of RAS proteins. RAS proteins have generally been called "undruggable" because potential therapeutics can't bind to their surfaces. But Revolution, using its tri-complex inhibitor platform, has found a way, producing "druggable" sites -- the investigational therapeutics then go on to block cancer signaling.

Revolution is exploring its candidates in cancers in which RAS proteins play a key role, and the company recently reported solid results from a phase 3 trial of previously treated metastatic pancreatic cancer. Daraxonrasib delivered a survival rate of 13.2 months versus a survival rate of 6.7 months for patients treated with the standard care of chemotherapy.

The company said these results are considered final, and it's submitting them to support a request for regulatory review. Revolution is also advancing another candidate, zoldonrasib, in phase 3 trials for the same indication.

Revolution has phase 3 trials ongoing for daraxonrasib in non-small cell lung cancer, and zoldonrasib as a combination therapy with standard of care is entering phase 3.

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Results just ahead And the biotech company is conducting earlier-stage trials in colorectal cancer and aims to share results of these combination studies -- with standard of care or investigational approaches -- this year.

Meanwhile, Revolution doesn't yet have products on the market, so it isn't generating revenue -- and due to this period of heavy investment in research and development, the company's loss in the recent quarter doubled from the year-earlier period to more than $453 million. The cash position at $1.9 billion and the $2.1 billion in net proceeds from financing should help support ongoing R&D.

The company clearly has developed an interesting approach to cancer treatment and has made significant progress in pancreatic cancer -- a key area where better treatments are needed. The fact that the company's lead candidate is approaching the finish line is positive, too, as that suggests a revenue stream may be right around the corner. So, if all goes smoothly, Revolution could be very close to becoming a commercial-stage biotech. This could reduce risk as a potential regulatory nod represents a vote of confidence for the technology that's used throughout the pipeline -- and would open the door to revenue and eventually profit.

And speaking of the financial picture, it's not worrisome to see the company's R&D costs climb right now -- this is a standard pattern across biotech companies in the clinical development stage.

Now, let's consider whether the stock is a buy. If you're a cautious investor, it's best to focus on biotech players that already have at least one product on the market and either are profitable or have made steps toward profitability. Biotech companies that aren't yet commercial-stage represent a certain amount of risk.

But, if you're a growth investor who can handle this risk, Revolution, even after its big gain, represents a compelling buy. This is because the company has shown the strength of its technology and may be very close to potential product approval. A regulatory nod and revenue growth to follow could result in significant gains, and Revolution's strong pipeline could lead to more strength down the road. All of this means that, over time, the stock may have plenty of room to run.

REDWOOD CITY, Calif., June 24, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that four oral and poster presentations highlighting data from its RAS(ON) pipeline will be featured at the 2026 European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress, taking place July 1–4, 2026 in Munich, Germany.

The program will include two oral presentations from Phase 1/2 trials evaluating zoldonrasib, an oral RAS(ON) G12D-selective covalent inhibitor, in combination regimens for patients with metastatic RAS G12D pancreatic ductal adenocarcinoma (PDAC). These presentations will report results from zoldonrasib plus chemotherapy in the first line setting, and zoldonrasib plus daraxonrasib, the company’s oral RAS(ON) multi-selective inhibitor, in patients who had received one or more prior lines of therapy.

Additional presentations will include two Phase 3 trials-in-progress posters for RASolute 303, evaluating daraxonrasib as a monotherapy or in combination with gemcitabine and nab-paclitaxel versus standard of care gemcitabine and nab-paclitaxel as a first line treatment for patients with metastatic PDAC, and RASolute 304, evaluating adjuvant daraxonrasib in patients with PDAC who have undergone resection and completed perioperative chemotherapy.

Details of Revolution Medicines’ presentations are listed below.

Revolution Medicines Oral Presentations:

Title:Safety and Efficacy of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) in Patients with 2L+ KRAS G12D Metastatic Pancreatic Adenocarcinoma (mPDAC)Abstract:#341OPresenter:Nilofer Azad, M.D., Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterSession:Proffered Paper SessionDate/Time:July 2; 2:50 p.m. – 3:00 p.m. CEST   Revolution Medicines Posters:

Title:RASolute 304 – A Phase 3 Multicenter, Open-label, Randomized Study of Adjuvant Daraxonrasib Versus Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Adenocarcinoma (PDAC)Abstract:#472TiPPresenter:Michel Ducreux, M.D., Ph.D., Institut Gustave RoussySession:Upper Digestive – Biliary, ampullary and pancreatic cancerDate/Time:July 3; 3:30 p.m. – 4:30 p.m. CEST   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 the progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied.

Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” "believe," "estimate," "expect," "plan," “potential,” “project,” “up to,” "will" 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’ development stages, the process of designing and conducting preclinical and clinical trials, 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 6, 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: 
[email protected]  
[email protected]