Revolution Medicines advances daraxonrasib NDA and reports new lung cancer combination data

Revolution Medicines said the FDA accepted for review its New Drug Application for daraxonrasib for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma, following the Phase 3 RASolute 302 results.¹ The company also opened an FDA-cleared Expanded Access Program in May and within three weeks began distributing daraxonrasib to participating physicians, with the drug distributed on behalf of more than 2,000 patients through academic and community cancer centers across nearly all 50 states and Puerto Rico as of the update.¹

In Europe, the European Medicines Agency initiated a phased review of daraxonrasib in pancreatic cancer under its Cancer Medicines Pathfinder project, evaluating sections as they become available ahead of a full Marketing Authorization Application submission.¹

In lung cancer, the FDA granted Breakthrough Therapy Designation to daraxonrasib for previously treated metastatic NSCLC patients with KRAS mutations other than G12C who had prior platinum chemotherapy and anti-PD-(L)1 therapy, based on Phase 1 data.¹ The company said enrollment in the global Phase 3 RASolve 301 trial in previously treated RAS mutant NSCLC is expected to complete this year, with an initial readout anticipated in 2027.¹

New combination data were also reported. For zoldonrasib plus pembrolizumab and chemotherapy in first-line RAS G12D NSCLC, as of a May 11, 2026 data cutoff with 3.4 months median follow-up, the combination showed an 82% overall response rate and 100% disease control rate,¹ supporting the recently initiated global Phase 3 RASolve 308 study.¹ For elironrasib in a similar first-line RAS G12C NSCLC combination, with 8.7 months median follow-up, the combination showed an 85% confirmed ORR and 97% disease control rate,¹ supporting the planned Phase 3 RASolve 307 study, expected to start in the fourth quarter of 2026.¹

On financing, the company completed concurrent public offerings in April 2026 raising $1,725.0 million in common stock and $500.0 million in convertible senior notes due 2033, for total gross proceeds of $2,225.0 million,¹ and received a $250.0 million payment from Royalty Pharma in May 2026 for additional royalty rights.¹ Cash, cash equivalents and marketable securities stood at $3.9 billion as of June 30, 2026,¹ with up to an additional $1.5 billion available under the Royalty Pharma arrangement subject to milestones.¹ Net loss for the quarter was $644.4 million, compared to $247.8 million a year earlier.¹ The company updated its full year 2026 GAAP operating expense guidance to $2.1 to $2.2 billion, including $270 to $290 million in non-cash stock-based compensation.¹