RVMD FDA decision: Aug 26, 2026

Rasonque (daraxonrasib) was approved by the FDA on August 26, 2026 to treat metastatic pancreatic cancer, the 34th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.

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)

Key facts

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.

Primary source: FDA press announcement, August 26, 2026

FDA record of the action: the FDA approved on August 26, 2026, per NDA 220910 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.

Specialist biotech funds holding RVMD, 13F for the quarter ended June 30, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.