This is a best-case Phase 3 readout for a pivotal asset. Expect significant upside at open. Monitor the NDA submission timeline and potential accelerated approval. The expanded access protocol signals FDA alignment. Long-term, watch for data in first-line PDAC and NSCLC trials which expand the addressable market.
Price Chart
Executive Summary
Revolution Medicines reported overwhelmingly positive Phase 3 data for daraxonrasib in metastatic pancreatic cancer, showing a 60% reduction in risk of death and median OS of 13.2 months vs 6.6 months for chemotherapy. The company plans to file an NDA using a priority voucher, and the FDA has authorized an expanded access protocol. These results position daraxonrasib as a potential new standard of care in a high-unmet-need indication.
Key Facts
- Phase 3 RASolute 302 trial met all primary and key secondary endpoints in previously treated metastatic PDAC.
- Daraxonrasib reduced risk of death by 60% (HR 0.40) in both RAS G12 and ITT populations.
- Median OS: 13.2 months daraxonrasib vs 6.6 months chemotherapy in RAS G12 population.
- Median PFS: 7.3 months daraxonrasib vs 3.5 months chemotherapy in RAS G12 population.
- Objective response rate: 33.2% daraxonrasib vs 11.8% chemotherapy in RAS G12 population.
- Grade 3+ TRAEs: 43.6% daraxonrasib vs 57.5% chemotherapy; discontinuation rate 1.2% vs 11.2%.
- Company intends to submit NDA using FDA Commissioner's National Priority Voucher.
- FDA authorized expanded access treatment protocol (EAP) for daraxonrasib.
- Daraxonrasib has Breakthrough Therapy and Orphan Drug designations for this indication.
Financial Impact
Transformative for a $33.5B market cap company with no approved products. Daraxonrasib could address a ~$5B+ annual market in second-line metastatic PDAC alone, with additional Phase 3 trials in first-line PDAC and NSCLC. The data support rapid regulatory filing and potential blockbuster revenue.
Risk Factors
- Regulatory approval is not guaranteed; FDA may request additional data or have concerns about the single Grade 5 pneumonitis event.
- Competition from other RAS inhibitors in development (e.g., from Amgen, Mirati/BMS) could emerge.
- Commercial execution risk: launching a novel oral therapy requires new infrastructure for a company with no prior commercial products.
- Payer reimbursement dynamics for a high-cost targeted therapy in a palliative setting.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3303919 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 15, 2026 16d ago | 144 | $195.92 $190.74 | ▼ −2.64% | ▼ −5.21% | $206.64 (+5.47%) |
Sep 15, 2026 16d ago | 144 | $195.92 $190.74 | ▼ −2.64% | ▼ −5.21% | $206.64 (+5.47%) |
Sep 15, 2026 17d ago | Insider Cluster | $204.86 $190.95 | ▼ −6.79% | ▼ −7.61% | $206.64 (+0.87%) |
Sep 14, 2026 17d ago | Insider Cluster | $204.86 $192.86 | ▼ −5.86% | ▼ −7.98% | $206.64 (+0.87%) |
Aug 26, 2026 5w ago | 8-K | $215.44 $209.23 | ▼ −2.88% | ▼ −2.76% | $206.64 (−4.08%) |
Aug 26, 2026 5w ago | Press Release | $215.44 $209.23 | ▼ −2.88% | ▼ −2.76% | $206.64 (−4.08%) |
Aug 25, 2026 5w ago | Insider Cluster | $211.38 $209.87 | ▼ −0.71% | ▼ −0.18% | $206.64 (−2.24%) |
Jul 2, 2026 13w ago | Press Release | $189.24 $191.13 | ▲ +1.00% | ▲ +0.07% | $206.64 (+9.19%) |
Jul 1, 2026 13w ago | Insider Cluster | $187.51 $190.46 | ▲ +1.57% | ▲ +1.31% | $206.64 (+10.20%) |
Jun 22, 2026 14w ago | 8-K | $165.81 $192.62 | ▲ +16.17% | ▲ +16.62% | $206.64 (+24.62%) |
US Market Status
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