Revolution Medicines Books First Rasonque Sales After FDA Nod

The Tip Desk · November 4, 2026 · 4 min read

Rasonque generated $197.6 million of net product revenue in about five weeks after August 26 FDA approval, as the company posted a $407.5 million net loss.

Revolution Medicines, Inc. (RVMD), a commercial-stage oncology company focused on RAS-addicted cancers, reported Rasonque (daraxonrasib) net product revenue of $197.6 million for the quarter ended September 30, 2026, after the U.S. Food and Drug Administration approved the oral RAS(ON) multi-selective inhibitor on August 26 and the company launched it commercially for about five weeks.

The prior quarter had ended with an accepted new drug application and an Expanded Access Program rather than a marketed product. From FDA approval through September 30, more than 5,000 unique patients received commercial Rasonque in the United States. The company said initial revenue included patients transitioning from the Expanded Access Program, patients who had exhausted available treatment options and were awaiting an approved option, newly eligible patients starting Rasonque after approval, and initial channel stocking. It said those EAP transitions and the waiting-patient cohort are finite early-launch dynamics and that third-quarter results should not be viewed as indicative of the launch’s longer-term trajectory.

Rasonque is indicated for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Claims have been reimbursed across health plans representing more than 90% of U.S. pancreatic cancer covered lives, the company said, as formal coverage policies continue to develop. NCCN guidelines were updated to list Rasonque as a Category 1 Preferred subsequent-therapy option for appropriate patients with locally advanced or metastatic pancreatic cancer, or with recurrent disease after prior systemic therapy.

In October, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorization of daraxonrasib in the European Union for metastatic pancreatic adenocarcinoma, following the prior quarter’s phased review under the EMA’s Cancer Medicines Pathfinder project. A European Commission decision remains pending. The company said it is building commercialization capabilities across priority European markets and Japan in preparation for potential international approvals.

Net loss widened to $407.5 million, or $1.90 a share, from $305.2 million, or $1.61 a share, a year earlier. The quarter included $40.7 million of non-cash charges related to a change in the fair value of warrants assumed in the EQRx acquisition.

Research and development expenses were $417.1 million, compared with $262.5 million a year earlier. The company attributed the increase primarily to higher clinical trial and manufacturing expenses for Rasonque, zoldonrasib and RMC-5127, additional headcount, and higher stock-based compensation. Selling, general and administrative expenses were $153.3 million, compared with $52.8 million a year earlier, driven primarily by additional headcount, commercial expenses from the Rasonque launch, and higher stock-based compensation. Cost of sales was $0.3 million; the company said that figure is not representative of normalized cost of sales because product sold included inventory manufactured before FDA approval whose manufacturing costs had previously been expensed to research and development.

Cash, cash equivalents and marketable securities were $3.7 billion as of September 30, 2026. That balance excludes $250 million of Royalty Pharma proceeds received in October after Rasonque’s U.S. approval triggered the mandatory first debt tranche. The company elected not to draw an optional third $250 million royalty tranche, leaving up to $1 billion of committed capital available, subject to milestones.

Revolution Medicines is reiterating full-year 2026 GAAP operating expense guidance of $2.1 billion to $2.2 billion, including expected non-cash stock-based compensation of $270 million to $290 million.

The company completed U.S. enrollment in RASolute 303 in treatment-naïve metastatic pancreatic cancer, with global enrollment expected in the first half of 2027. The FDA granted Breakthrough Therapy Designation for daraxonrasib plus gemcitabine and nab-paclitaxel in that setting. Zoldonrasib received Orphan Drug Designation for pancreatic cancer, and the company began treating patients in RASolute 309, a Phase 3 doublet of daraxonrasib plus zoldonrasib in treatment-naïve metastatic RAS G12D pancreatic cancer.

In non-small cell lung cancer, global enrollment in RASolve 301 is winding down, with sites expected to close by the end of November 2026 and an initial readout anticipated in 2027. NCCN guidelines were updated to list Rasonque as a Category 2A targeted agent for metastatic NSCLC with KRAS G12, G13 or Q61 mutations; daraxonrasib remains investigational for NSCLC. The company also initiated RASolve 307 for elironrasib in treatment-naïve metastatic RAS G12C NSCLC and began treating patients in RASolve 308 for zoldonrasib combinations in RAS G12D NSCLC.

Since the last quarterly update, Revolution Medicines announced an August multi-part collaboration and regional rights agreement with BeOne Medicines covering four clinical-stage RAS(ON) inhibitors in select Asian markets, and October collaborations with Bristol Myers Squibb to evaluate pumitamig in four early-stage combination cohorts.