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Revolution Medicines, Inc. develops targeted oncology therapies for patients with RAS-addicted cancers. Company news centers on its RAS(ON) inhibitor pipeline, including daraxonrasib, a RAS(ON) multi-selective inhibitor, and selective programs such as elironrasib, zoldonrasib and RMC-5127.
Recurring updates cover clinical data in pancreatic ductal adenocarcinoma, non-small cell lung cancer and other RAS-mutant solid tumors, presentations at oncology meetings, scientific publications, regulatory interactions and trial-stage progress. Revolution Medicines also reports quarterly financial results, financing activity and corporate progress tied to research and development, potential commercialization planning and its broader RAS(ON) discovery platform.
Revolution Medicines (RVMD) received U.S. FDA Breakthrough Therapy Designation for RASONQUE (daraxonrasib) with gemcitabine and nab-paclitaxel in first-line metastatic pancreatic adenocarcinoma (PDAC).
The designation covers treatment-naïve metastatic PDAC in combination with this multiagent chemotherapy regimen and is based on preliminary Phase 1/2 RMC-GI-102 data in RAS mutant metastatic PDAC, where the regimen showed encouraging antitumor activity and a manageable safety profile. These results informed RASolute 303, an ongoing global Phase 3 trial evaluating RASONQUE as monotherapy and with chemotherapy versus chemotherapy alone in previously untreated metastatic PDAC, regardless of tumor RAS genotype. RASONQUE already has U.S. approval as an oral therapy for adults with metastatic PDAC after at least one prior systemic therapy or who are not candidates for multiagent systemic therapy, while first-line combination use remains investigational.
Revolution Medicines (RVMD)/b) reported New England Journal of Medicine publication of Phase 1/2 data on RASONQUE™ (daraxonrasib) in RAS mutant metastatic NSCLC.The RMC-6236-001 trial (data cutoff July 21, 2025) evaluated once-daily doses ≤300 mg in 136 previously treated NSCLC patients with non‑G12C RAS mutations after platinum chemotherapy and anti‑PD‑(L)1 therapy. In a 160–220 mg subgroup of 38 docetaxel‑naïve patients, confirmed objective response rate was 42% (95% CI, 26%–59%), disease control rate 89% (95% CI, 75%–97%), median progression‑free survival 8.3 months (95% CI, 4.0–12.5) and median overall survival 16.0 months (95% CI, 9.5–not estimable). At these doses, Grade 3 treatment‑related adverse events occurred in 25% of patients, mainly rash (8%) and diarrhea (3%), with no Grade 4 or 5 TRAEs reported. The company said these findings support RASolve 301, an ongoing global randomized Phase 3 trial comparing RASONQUE with docetaxel in previously treated RAS mutant NSCLC.
Revolution Medicines (Nasdaq: RVMD) received U.S. FDA approval for once-daily oral RASONQUE (daraxonrasib) 300 mg tablets to treat adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. The label covers patients with or without an identified RAS tumor mutation and does not require a companion diagnostic.
Approval is based on the global Phase 3 RASolute 302 trial, where RASONQUE reduced risk of death by 60% versus chemotherapy (HR 0.40) in the intent-to-treat population, with median overall survival of 13.2 months vs 6.7 months. Progression-free survival improved to 7.2 vs 3.6 months (HR 0.49), and patient-reported outcomes showed longer maintenance of global health status (5.7 vs 2.6 months) and delay in worsening pain (9.2 vs 3.8 months). The most common adverse reactions included rash, diarrhea and stomatitis, and the label carries warnings for dermatologic toxicity, stomatitis, diarrhea, gastrointestinal perforation, interstitial lung disease/pneumonitis and embryo-fetal toxicity. RASONQUE is now commercially available in the U.S. with patient support through the (ON)Path program, while daraxonrasib remains investigational outside the U.S. with EMA review underway.
BeOne Medicines (Nasdaq: ONC; HKEX: 06160; SSE: 688235) and Revolution Medicines (Nasdaq: RVMD) announced a multi-part collaboration covering clinical development of drug combinations and regional commercialization for RAS-addicted cancers.
The clinical collaboration will evaluate combinations of select BeOne oncology assets, including BGB-58067 (MTA-cooperative PRMT5 inhibitor) and BG-T187 (EGFR x MET x MET trispecific antibody), with any of Revolution Medicines’ four clinical RAS(ON) inhibitors: daraxonrasib (multi-selective), zoldonrasib (G12D-selective), elironrasib (G12C-selective) and RMC-5127 (G12V-selective). Under a separate regional rights agreement, Revolution Medicines granted BeOne exclusive rights in select Asian markets to develop and commercialize, or solely commercialize, these four assets. Revolution Medicines is eligible for development and sales milestones and tiered royalties on net sales, and retains rights outside the licensed territory, including Japan and South Korea. BeOne will fund and conduct a global registrational Phase 3 study for one RAS(ON) inhibitor.
Revolution Medicines (Nasdaq: RVMD) reported second quarter 2026 results and major clinical, regulatory and financing milestones. The U.S. FDA accepted the New Drug Application for daraxonrasib in previously treated metastatic pancreatic cancer, following Phase 3 RASolute 302 data showing significant improvements in survival, progression-free survival and quality of life versus chemotherapy. The EMA began a phased review under its Cancer Medicines Pathfinder project, and Swissmedic granted Orphan Drug Status. An FDA-cleared Expanded Access Program has already enabled daraxonrasib distribution to treating physicians on behalf of more than 2,000 patients across nearly all U.S. states and Puerto Rico.
Daraxonrasib also received FDA Breakthrough Therapy Designation for certain previously treated metastatic RAS mutant NSCLC, and multiple Phase 3 trials in pancreatic and lung cancer are underway or planned. Zoldonrasib and elironrasib combinations in first-line NSCLC showed preliminary overall response rates of 82% and 85%, respectively, with high disease control and manageable safety. Cash, cash equivalents and marketable securities totaled $3.9 billion at June 30, 2026, after $2.225 billion in April equity and convertible note offerings and a $250 million Royalty Pharma payment, though quarterly net loss widened to $644.4 million.
Revolution Medicines (Nasdaq: RVMD) will report its second quarter 2026 financial results on Wednesday, August 5, 2026, after market close. At 4:30 p.m. ET (1:30 p.m. PT), senior management will host a live webcast, with a replay available on the company’s investor relations website for at least 14 days.
Revolution Medicines (Nasdaq: RVMD) reported that the U.S. FDA has accepted for review its New Drug Application (NDA) for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, to treat adults with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
The NDA is supported by the global Phase 3 RASolute 302 trial comparing daraxonrasib monotherapy with standard cytotoxic chemotherapy. According to Revolution Medicines, the study met all primary and key secondary endpoints, showing improvements in overall survival, progression-free survival, response outcomes, and patient‑reported quality of life, with a manageable safety profile.
Daraxonrasib has FDA Breakthrough Therapy and Orphan Drug designations and was selected for the FDA Commissioner’s National Priority Voucher pilot program. In Europe, the EMA has started a phased review and granted orphan medicine designation and high-priority status under its Cancer Medicines Pathfinder project.
Revolution Medicines (Nasdaq: RVMD) reported that EMA’s CHMP has begun a phased review of daraxonrasib for pancreatic cancer, aiming to accelerate assessment before a full marketing application.
Daraxonrasib has EMA orphan drug status, Cancer Medicines Pathfinder priority, and a rolling NDA submission to the U.S. FDA nearing completion, supported by positive Phase 3 RASolute 302 data.
Revolution Medicines (Nasdaq: RVMD) reported Phase 1/2 data for zoldonrasib combinations in RAS G12D metastatic pancreatic cancer at ESMO GI 2026.
First-line zoldonrasib plus chemotherapy showed ORR up to 82%, while zoldonrasib plus daraxonrasib in pretreated patients showed ORR of 47–50%, supporting pivotal Phase 3 RASolute 305 and 309 trials.
Revolution Medicines (RVMD) will present new clinical data from its RAS(ON) inhibitor combination trials in pancreatic cancer at the ESMO Gastrointestinal Cancers Congress 2026, July 1–4 in Munich.
The program features two Phase 1/2 zoldonrasib combination orals and two Phase 3 RASolute trial posters in PDAC.