Item 8.01 Other Events On August 26, 2026, the U.S. Food and Drug Administration approved RASONQUE™ (daraxonrasib) for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy (the “FDA Approval”).…
Filed Aug 26, 2026Accepted Aug 26, 2026, 1:33 PM EDTCIK 1628171Accession 0001193125-26-366931
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. These product candidates are investigational and have not been approved for commercial use in any indication. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.
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Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events
On August 26, 2026, the U.S. Food and Drug Administration approved RASONQUE™ (daraxonrasib) for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy (the “FDA Approval”).
The FDA Approval was based on data from RASolute 302, a global, randomized Phase 3 clinical trial evaluating RASONQUE versus investigator’s choice of cytotoxic chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma.
Once-daily oral RASONQUE tablets are now available in the United States for physicians to prescribe to eligible patients. The wholesale acquisition cost of RASONQUE is $39,800 for a 30-day supply, based on the recommended daily dose.