pdufa.bio

Daraxonrasib (RMC-6236)

Updated ยทnext FDA decision on the calendar

Daraxonrasib (RMC-6236) is a Revolution Medicines, Inc. program in Previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). It is under FDA review; the agency's action date has not been publicly disclosed. Every date links its source.

About this program

Indication under review: Previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). Sponsor: Revolution Medicines, Inc. (RVMD). Review status: NDA accepted for review 2026-07-22 on the Phase 3 RASolute 302 trial (all primary and key secondary endpoints met, incl. overall survival). Breakthrough Therapy and Orphan Drug designations; selected for the FDA Commissioner's National Priority Voucher pilot. No PDUFA goal date has been publicly disclosed. We track 1 catalyst event for this program: 1 upcoming and 0 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.

Catalyst history

PDUFA · NDA accepted 2026-07-22; action date not publicRVMD

Questions

When is Daraxonrasib (RMC-6236)'s next FDA decision or readout?

Daraxonrasib (RMC-6236) is under FDA review, but no action date has been publicly disclosed (NDA accepted 2026-07-22; action date not public). The review status row below links the sponsor's own announcement; this page updates when a date becomes public.

What happened at Daraxonrasib (RMC-6236)'s most recent FDA decision?

No FDA decision for Daraxonrasib (RMC-6236) is in our archive yet.

What is Daraxonrasib (RMC-6236) used for?

In our records Daraxonrasib (RMC-6236) is under review or in development for Previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

Who makes Daraxonrasib (RMC-6236)?

Revolution Medicines, Inc. (RVMD).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.