RVMD Revolution Medicines, Inc.
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.
Actionable Insight
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.
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
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3303919 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
|
May 31, 2026
9d ago
|
Press Release
| $163.68 $149.23 | ▼ −8.83% | ▼ −6.08% | $149.55 (−8.63%) |
|
May 6, 2026
4w ago
|
Press Release
| $142.51 $149.94 | ▲ +5.21% | ▲ +3.71% | $149.55 (+4.94%) |
|
Apr 21, 2026
7w ago
|
Press Release
| $141.50 $140.80 | ▼ −0.49% | ▼ −0.55% | $149.55 (+5.69%) |
|
Apr 21, 2026
7w ago
|
Press Release
| $141.50 $140.80 | ▼ −0.49% | ▼ −0.55% | $149.55 (+5.69%) |
|
Apr 21, 2026
7w ago
|
Press Release
| $148.90 $144.83 | ▼ −2.73% | ▼ −3.82% | $149.55 (+0.44%) |
|
Apr 19, 2026
7w ago
|
Press Release
| $146.23 $131.67 | ▼ −9.96% | ▼ −10.87% | $149.55 (+2.27%) |
|
Apr 17, 2026
7w ago
|
Press Release
| $146.23 $131.67 | ▲ +9.96% | ▲ +10.87% | $149.55 (−2.27%) |
|
Apr 15, 2026
7w ago
|
Press Release
| $152.54 $141.50 | ▲ +7.24% | ▲ +8.88% | $149.55 (+1.96%) |
|
Apr 13, 2026
8w ago
|
Press Release
| $147.01 $148.90 | ▼ −1.29% | ▲ +0.11% | $149.55 (−1.73%) |
|
Mar 19, 2026
11w ago
|
Insider Cluster
| $99.29 $93.21 | ▼ −6.12% | ▼ −3.91% | $149.55 (+50.62%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access