Revolution Medicines (NASDAQ:RVMD) said its second-quarter 2026 results reflected continued investment in late-stage cancer programs, commercial launch preparations and manufacturing capacity as it advances daraxonrasib and other RAS-targeted therapies across pancreatic and lung cancer.
The company ended the quarter with $3.9 billion in cash and investments, including proceeds from April offerings of common stock and convertible notes that generated $2.2 billion in gross proceeds, as well as a $250 million second royalty tranche from Royalty Pharma. Revolution Medicines said up to an additional $1.5 billion remains available under that funding arrangement if specified milestones are achieved.
Daraxonrasib regulatory and access progress
Chairman and Chief Executive Officer Mark Goldsmith said the company’s new drug application for daraxonrasib in previously treated metastatic pancreatic cancer has been accepted for review by the U.S. Food and Drug Administration. The application is supported by the completed Phase III RASolute 302 study, whose results were presented at the American Society of Clinical Oncology meeting and published in the New England Journal of Medicine.
Goldsmith said RASolute 302 showed statistically significant and clinically meaningful improvements in overall survival, progression-free survival and patient-reported quality-of-life measures for daraxonrasib monotherapy compared with chemotherapy, with what the company described as a manageable safety and tolerability profile.
Revolution Medicines has also established an FDA-cleared expanded access program for eligible U.S. patients. Goldsmith said the program has activated sites in nearly all 50 states and Puerto Rico, spanning academic cancer centers and community oncology practices. The company has approved more than 90% of reviewed requests and provided daraxonrasib on behalf of more than 2,000 eligible patients.
In Europe, the European Medicines Agency has designated daraxonrasib as a high priority under its Cancer Medicines Pathfinder and started a phased review intended to accelerate assessment ahead of a full marketing authorization application. Goldsmith said the company is continuing discussions with the EMA and other regulatory authorities.
The company said its U.S. commercial infrastructure is in place for a potential launch, including a sales organization, field access team, patient services program, commercial supply and distribution network. Anthony Mancini, chief global commercialization officer, said the sales organization includes about 60 individuals and is designed to support a pancreatic cancer launch while broader commercialization infrastructure could support future indications.
Pancreatic cancer pipeline expands
Revolution Medicines continues to enroll patients in the Phase III RASolute 303 study in first-line metastatic pancreatic cancer and RASolute 304 study in the adjuvant setting, both involving daraxonrasib. The company is also enrolling patients in RASolute 305, a Phase III study of zoldonrasib plus chemotherapy in first-line metastatic pancreatic cancer with RAS G12D mutations.
The company recently initiated RASolute 309, a Phase III study evaluating the combination of daraxonrasib and zoldonrasib in the first-line RAS G12D pancreatic cancer setting.
At the European Society for Medical Oncology Gastrointestinal Cancers Congress, Revolution Medicines reported preliminary data for zoldonrasib combined with chemotherapy in first-line RAS G12D pancreatic cancer. The company reported objective response rates of 82% with modified FOLFIRINOX and 61% with gemcitabine plus nab-paclitaxel, with disease control rates of 96% and 90%, respectively. It said longer follow-up is needed to assess durability.
In another study, the daraxonrasib-zoldonrasib doublet produced objective response rates of 50% in second-line patients and 47% in patients treated in the third line or later, according to the company. Median progression-free survival was 9.6 months in the second-line group and 7.6 months in the later-line group. Median overall survival had not been reached in the second-line setting, while it was 10.5 months in the third-line-or-later group.
Lung cancer programs move toward registrational studies
Chief Development Officer Alan Sandler said the company is advancing mutant-selective RAS(ON) inhibitors in first-line non-small cell lung cancer. The FDA has granted breakthrough therapy designation to daraxonrasib for previously treated metastatic non-small cell lung cancer with KRAS mutations other than G12C in patients who previously received platinum chemotherapy and PD-1 or PD-L1 therapy.
Revolution Medicines expects to complete enrollment in its Phase III RASolve 301 study of daraxonrasib in previously treated RAS-mutant non-small cell lung cancer this year, supporting an initial readout in 2027.
The company also disclosed early combination data for zoldonrasib and elironrasib with pembrolizumab and platinum-based chemotherapy in previously untreated non-small cell lung cancer. In KRAS G12D disease, zoldonrasib’s combination produced an 82% objective response rate and disease control in all evaluable patients after a median 3.4 months of follow-up as of May 11.
For elironrasib in RAS G12C non-small cell lung cancer, the company reported an 85% confirmed objective response rate, a 97% disease control rate and a 95% progression-free survival rate at six months, based on median follow-up of 8.7 months. Sandler said safety findings for both regimens were broadly consistent with pembrolizumab-based chemotherapy, with no new or unexpected safety signals reported for zoldonrasib.
Revolution Medicines has initiated RASolve 308, a randomized placebo-controlled study of zoldonrasib plus pembrolizumab and platinum-doublet chemotherapy in RAS G12D non-small cell lung cancer. It expects to begin RASolve 307, a similar study of elironrasib in RAS G12C disease, in the fourth quarter of 2026.
Expenses and outlook
Research and development expense increased to $395 million from $224 million a year earlier, primarily reflecting higher clinical trial and manufacturing costs for daraxonrasib and zoldonrasib, additional personnel and stock-based compensation. General and administrative expense rose to $110 million from $41 million, driven by headcount, commercialization preparations and administrative costs.
The company increased its full-year 2026 GAAP operating expense forecast to between $2.1 billion and $2.2 billion, including expected non-cash stock-based compensation of $270 million to $290 million. Chief Financial Officer Jack Anders said the higher outlook reflects accelerated manufacturing for clinical and potential commercial supply, expanded clinical development activity and increased U.S. and international commercialization investments.
Goldsmith said Revolution Medicines plans to provide a colorectal cancer data update and outline its development plans in the fourth quarter. The company also expects to identify a recommended Phase II dose for RMC-5127 in the second half of 2026 and initiate a first-in-human study of RM-055 in the fourth quarter.
About Revolution Medicines (NASDAQ:RVMD)
Revolution Medicines is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapies to treat RAS-dependent cancers and other diseases driven by the RAS/MAPK pathway. The company’s research efforts target historically “undruggable” proteins, aiming to inhibit critical nodes in cell signaling that promote tumor growth and therapeutic resistance.
The lead pipeline includes RMC-4630, a SHP2 inhibitor; RMC-6291, a selective KRAS G12C inhibitor; and RMC-6236, a pan-RAS inhibitor designed to address multiple RAS mutations.
