Daraxonrasib (RMC-6236) is a Revolution Medicines, Inc. program in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The FDA approved it on Aug 26, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Sponsor: Revolution Medicines, Inc. (RVMD). Decision record: NDA accepted for review 2026-07-22 on the Phase 3 RASolute 302 trial (all primary and key secondary endpoints met, including overall survival). Breakthrough Therapy and Orphan Drug designations; Priority Review; selected for the FDA Commissioner's National Priority Voucher pilot. No PDUFA goal date was ever publicly disclosed. The FDA approved on August 26, 2026, as Rasonque, per the agency's own announcement 6.5 months before the user fee deadline. Also searched as daraonrasib. People searching for this drug frequently type "daraonrasib", dropping the x. It is the same molecule: daraxonrasib (RMC-6236). We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Baker Bros. Advisors | 11,443,357 | $2.14 billion | filed August 14, 2026 |
| BVF Inc. | 2,965,160 | $555.3 million | filed August 14, 2026 |
| Avoro Capital Advisors | 2,297,000 | $430.2 million | filed August 14, 2026 |
| Perceptive Advisors | 527,600 | $98.8 million | filed August 14, 2026 |
| OrbiMed Advisors | 70,500 | $13.2 million | filed August 14, 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.
No upcoming catalyst is on our calendar for Daraxonrasib (RMC-6236); 1 FDA decision is on record below.
On Aug 26, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
Revolution Medicines, Inc. (RVMD).
Yes. The FDA approved an application for Daraxonrasib (RMC-6236) on Aug 26, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.