Revolution Medicines received FDA Orphan Drug Designation for its RAS(ON) multi‑selective inhibitor daraxonrasib for the treatment of pancreatic ductal adenocarcinoma (PDAC).
The designation provides tax credits for clinical‑trial costs, exemption from certain FDA user fees, and up to seven years of market exclusivity following approval.
Daraxonrasib is currently being evaluated in the global Phase 3 RASolute 302 trial, enrolling patients with second‑line metastatic PDAC. The company also plans two additional Phase 3 studies—one for first‑line metastatic disease and another for adjuvant treatment of resectable PDAC.
In addition to the orphan designation, daraxonrasib received Breakthrough Therapy Designation on 2025‑06‑23 for KRAS G12‑mutated, previously treated metastatic PDAC. The drug targets oncogenic RAS mutations G12X, G13X, and Q61X, which are present in over 90 % of pancreatic cancers. CEO Mark A. Goldsmith emphasized the urgent need for new therapies, noting the disease’s low five‑year survival rate of approximately 3 %.
Revolution Medicines secured a potential $2 billion partnership with Royalty Pharma in June 2025, with milestone‑based tranches tied to daraxonrasib’s regulatory and commercial milestones. The combination of high mutation prevalence, regulatory incentives, and financial backing positions daraxonrasib as a key asset in the company’s pipeline.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.