- Trial Phase
- Phase 3 (completed with positive results) / pre-NDA
- Time to Market
- NDA submission pending; potential approval in 2L PDAC possibly by Q3 2026 per Truist analyst projection, though no PDUFA date is confirmed
- Why 5/10
- The next hard catalyst is the NDA submission for daraxonrasib in 2L metastatic PDAC (company stated intent to file April 2026 under the CNPV pilot program; Truist projects approval by end of Q3 2026). However, the defining binary event — the Phase 3 RASolute 302 topline readout — already passed on April 13, 2026, and the stock has repriced substantially (up ~258% in 12 months). With no confirmed PDUFA date yet, the remaining binary (FDA approval decision) has limited incremental upside from current levels, capping the impactScore at 5.
Daraxonrasib's Phase 3 success in 2L pancreatic cancer is already priced in after the stock surged near its 52-week high. Near-term upside hinges on formal NDA acceptance and a confirmed PDUFA date. Watch for the NDA filing announcement, which could trigger a smaller bump, but the big binary is behind us. The real long-term story is the broader pipeline (RASolute 303 in 1L PDAC, RASolve 301 in NSCLC) — those future readouts are multi-year catalysts.
Price Chart
Executive Summary
Daraxonrasib (RMC-6236) is Revolution Medicines' lead asset — an oral, pan-RAS inhibitor that just delivered what analysts and doctors are calling "unprecedented" Phase 3 results in metastatic pancreatic cancer, nearly doubling median overall survival vs chemotherapy (13.2 vs 6.7 months, HR 0.40). The FDA has granted Breakthrough Therapy, Orphan Drug, and a National Priority Voucher, signaling an accelerated regulatory path. Truist projects approval in 2L PDAC by end of Q3 2026. The stock has already rallied ~258% over the past 12 months on this success, and the defining binary event (Phase 3 readout) is behind it. The next catalyst is the NDA filing and FDA decision, but significant upside from current levels near the 52-week high may be limited until the broader pipeline (1L PDAC, NSCLC) matures.
How It Works
Daraxonrasib is an oral pill that targets a family of cancer-driving proteins called RAS (including KRAS, NRAS, HRAS). It works by binding to a chaperone protein inside cells, forming a "molecular glue" complex that latches onto the active form of RAS and shuts it down. Unlike earlier KRAS drugs that only work on one specific mutation (G12C), daraxonrasib works across a broad range of RAS mutations — including types found in pancreatic, lung, and colorectal cancers — as well as normal RAS that some cancers depend on.
Trial Status
The global Phase 3 RASolute 302 trial (NCT06625320) in previously treated metastatic PDAC met its primary endpoint (overall survival) with topline results announced April 13, 2026. Detailed ASCO 2026 presentation showed daraxonrasib nearly doubled median OS (13.2 vs 6.7 months, HR 0.40). The company initiated RASolute 303 (Phase 3, 1L PDAC) in April 2026 and has RASolve 301 (Phase 3, NSCLC) ongoing. FDA granted expanded access in May 2026.
The Two-Sided Case
Upcoming Catalysts
- NDA submission for daraxonrasib in 2L metastatic PDAC (company stated intent April 2026; Truist projects approval by end of Q3 2026).
- FDA acceptance of NDA filing and assignment of PDUFA date — would confirm the regulatory timeline.
- RASolute 303 Phase 3 trial data (1L metastatic PDAC) — longer-term readout, no estimated date yet.
- RASolve 301 Phase 3 trial data (NSCLC) — longer-term readout, no estimated date yet.
- Potential FDA Advisory Committee meeting (if required) for daraxonrasib NDA.
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Revolution Medicines, Inc. Press Release RVMD ·Originating report