Rasonque (daraxonrasib), a first-in-class RAS inhibitor, approved for previously treated metastatic pancreatic adenocarcinoma (Aug 26 2026).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (3/5/26) through T+5. Run-up high $216 on 8/18/26, low $92.51 on 3/27/26 (T-120 to T-1). FDA decision 8/26/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-08-26
OutcomeApproved
Drug / candidateRasonque (daraxonrasib)
IndicationMetastatic pancreatic adenocarcinoma after at least one prior systemic therapy, or in patients not candidates for multiagent systemic therapy
CompanyRevolution Medicines, Inc.
Market-cap tierLarge
120-day run-up (T-120→T-1)+112.1%
Cohort decision-day move (history)1.0% median (n=833)
Per the FDA's own announcement, the approval came 6.5 months before the user fee deadline, which places the goal date around mid-March 2027; no day-precision PDUFA date was ever publicly disclosed, so this application was never a dated event on our calendar. The application carried Breakthrough Therapy, Orphan Drug and Priority Review designations and was reviewed under the Commissioner's National Priority Voucher pilot. In the randomized trial, median overall survival was 13.2 months versus 6.7 months for standard chemotherapy.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.