- Daraxonrasib demonstrated unprecedented survival benefit in Phase 3 RASolute 302 trial in previously treated metastatic pancreatic cancer; detailed results will be presented in upcoming ASCO Plenary presentation
- RASolute 302 data planned for submission to global regulatory authorities, including the
U.S. Food and Drug Administration - AACR 2026 presentations reinforce the breadth and strength of company’s RAS(ON) portfolio, highlighting continued progress and novel approaches to RAS(ON) inhibition
- Strengthened financial position with financings totaling
$2.2 billion in gross proceeds Revolution Medicines to hold webcast today at4:30 p.m. Eastern Time
“Last month we reported positive results from the RASolute 302 trial of daraxonrasib, demonstrating an unprecedented improvement in overall survival in patients with previously treated metastatic pancreatic cancer,” said
Clinical Highlights
Pancreatic Ductal Adenocarcinoma (PDAC)
Daraxonrasib in PDAC
Daraxonrasib, a pioneering oral RAS(ON) multi-selective inhibitor, continues to demonstrate a differentiated clinical profile across lines of therapy and in both monotherapy and combination settings.
The company recently announced positive topline results from the pivotal, randomized Phase 3 RASolute 302 trial in second line (2L) PDAC, marking a major milestone in the development of daraxonrasib by showing its potential to improve patient outcomes. Daraxonrasib demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared to standard of care cytotoxic chemotherapy. In the overall (intent-to-treat) study population, daraxonrasib demonstrated a median OS of 13.2 months versus 6.7 months for chemotherapy (hazard ratio 0.40; p<0.0001). Daraxonrasib was generally well tolerated, with no new safety signals.
These results are considered final for PFS and OS, and
The company also presented at the 2026
- RMC-6236-001: Daraxonrasib monotherapy demonstrated a manageable safety profile and encouraging clinical activity, including early signs of durability.
- RMC-GI-102: Daraxonrasib in combination with standard of care chemotherapy demonstrated a manageable safety profile and encouraging clinical activity, including early signs of durability.
The company continues to evaluate daraxonrasib in two additional global randomized registrational Phase 3 studies in adjuvant and 1L metastatic PDAC:
- RASolute 303: The company recently announced that it has begun treating patients to evaluate daraxonrasib as monotherapy and in combination with chemotherapy in patients with 1L metastatic disease.
- RASolute 304: Enrollment continues in the registrational trial evaluating daraxonrasib monotherapy in the adjuvant setting in patients with resectable pancreatic cancer following surgery and perioperative chemotherapy.
Daraxonrasib recently received a positive opinion from the
Zoldonrasib in PDAC
Zoldonrasib, an innovative oral RAS(ON) G12D-selective covalent inhibitor, has shown a highly differentiated safety and tolerability profile as monotherapy and is also being evaluated across a range of combination regimens.
The company is advancing two registrational PDAC 1L Phase 3 studies incorporating zoldonrasib in combination:
- RASolute 305: A randomized, double-blind, placebo-controlled trial evaluating zoldonrasib in combination with chemotherapy has been initiated.
- RASolute 309: The company remains on track to initiate, in the second half of 2026, a registrational trial evaluating the RAS(ON) inhibitor doublet combination of zoldonrasib plus daraxonrasib.
Non-Small Cell
Daraxonrasib in NSCLC
RASolve 301, a global, randomized Phase 3 trial evaluating daraxonrasib monotherapy in patients with previously treated NSCLC, continues enrolling patients in the
The company remains on track to provide an update on its plans for advancing daraxonrasib combination therapy in 1L NSCLC this year.
Zoldonrasib in NSCLC
The company presented data at the AACR Annual Meeting evaluating zoldonrasib monotherapy in patients with previously treated RAS G12D NSCLC, which demonstrated encouraging clinical activity and a generally well tolerated safety profile consistent with previously reported findings. The Phase 2 monotherapy expansion cohort in patients with previously treated NSCLC has fully enrolled to provide a more robust assessment of clinical activity and increased optionality.
The company remains on track to initiate RASolve 308, a randomized, placebo-controlled Phase 3 trial evaluating zoldonrasib in combination with standard of care as 1L treatment for patients with metastatic RAS G12D NSCLC, in the first half of 2026.
Elironrasib in NSCLC
The company remains on track to share an update on its registrational strategy for elironrasib, an innovative oral RAS(ON) mutant-selective inhibitor that binds selectively and covalently to RAS G12C, in 2026.
Colorectal Cancer (CRC)
The company is advancing multiple combination trials in colorectal cancer, including evaluations of RAS(ON) inhibitor doublets and combinations with standard of care and other investigational approaches.
The company remains on track to share updated combination data in CRC this year as it evaluates potential paths toward pivotal development.
Clinical Collaborations
The company’s development efforts continue to involve clinical collaborations studying its RAS(ON) inhibitors with other targeted therapies, including:
- The APEX-103 trial, conducted in collaboration with Summit Therapeutics, Inc. (Summit), is ongoing, evaluating Revolution Medicines’ RAS(ON) inhibitors in combination with ivonescimab, Summit’s PD-1/VEGF bispecific antibody, across multiple solid tumor settings.
- A clinical collaboration with Tango Therapeutics, Inc. (Tango) is ongoing, evaluating Revolution Medicines’ RAS(ON) inhibitors in combination with vopimetostat, Tango’s MTA-cooperative PRMT5 inhibitor, in patients with tumors carrying both a RAS mutation and MTAP deletion.
- A clinical collaboration with Bristol Myers Squibb (BMS) is ongoing, evaluating daraxonrasib in combination with navlimetostat, BMS’ MTA-cooperative PRMT5 inhibitor, in patients with pancreatic cancer whose tumors carry both a RAS mutation and MTAP deletion.
Early-Stage Programs
RMC-5127
RMC-5127, an oral RAS(ON) G12V-selective inhibitor, is currently being evaluated in a first-in-human clinical trial, with patients actively enrolling in the dose escalation portion of the study. The company remains on track to identify a recommended monotherapy Phase 2 dose for this compound in the second half of 2026.
Innovative New Class of RAS(ON) Inhibitors
At the AACR Annual Meeting the company presented preclinical data showing that
The company remains on track to initiate a first-in-human clinical trial of
Other Corporate Updates
In
In support of the company’s growing global commercialization capabilities, the company also recently appointed several leaders across the
Financial Highlights
First Quarter Results
Cash Position: Cash, cash equivalents and marketable securities were
Stock-Based Compensation Expense: Stock-based compensation expense was
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
Financial Guidance
Webcast
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the
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, commercialization preparation and launch readiness, 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
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) | |||||||||
| Three Months Ended | |||||||||
| 2026 | 2025 | ||||||||
| Operating expenses: | |||||||||
| Research and development | $ | 343,970 | $ | 205,749 | |||||
| General and administrative | 101,252 | 35,011 | |||||||
| Total operating expenses | 445,222 | 240,760 | |||||||
| Loss from operations | (445,222 | ) | (240,760 | ) | |||||
| Non-operating income (expense), net: | |||||||||
| Interest income | 19,508 | 24,915 | |||||||
| Interest expense | (12,197 | ) | - | ||||||
| Change in fair value of warrant liability | (15,788 | ) | 2,439 | ||||||
| Other expense, net | (117 | ) | (10 | ) | |||||
| Total non-operating income (loss), net | (8,594 | ) | 27,344 | ||||||
| Net loss | $ | (453,816 | ) | $ | (213,416 | ) | |||
| Net loss per share attributable to common stockholders - basic and diluted | $ | (2.29 | ) | $ | (1.13 | ) | |||
| Weighted-average common shares used to compute net loss per share, basic and diluted | 198,098,047 | 188,145,904 | |||||||
SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, unaudited) | ||||||||
2026 | 2025 | |||||||
| Cash, cash equivalents and marketable securities | $ | 1,908,084 | $ | 2,025,679 | ||||
| Working capital (1) | 1,678,314 | 1,784,613 | ||||||
| Total assets | 2,253,737 | 2,354,508 | ||||||
| Total liabilities | 753,820 | 723,211 | ||||||
| Total stockholders' equity | 1,499,917 | 1,631,297 | ||||||
(1) Working capital is defined as current assets less current liabilities.
Source: 