The strong Phase 1 data de-risk zoldonrasib’s development and support potential accelerated approval pathways; traders should monitor for upcoming Phase 2 trial initiation or combination study readouts as next catalysts.
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Executive Summary
Revolution Medicines announced updated Phase 1 data for zoldonrasib in KRAS G12D non-small cell lung cancer, showing a 52% confirmed objective response rate and 11.1-month median progression-free survival, supporting its potential as a first-in-class targeted therapy for a high-unmet-need population.
Key Facts
- Zoldonrasib showed a 52% confirmed objective response rate (ORR) in 27 evaluable KRAS G12D NSCLC patients previously treated with immunotherapy and chemotherapy.
- Median progression-free survival (PFS) was 11.1 months, with a 12-month PFS rate of 48%.
- The safety profile was manageable, with Grade 3 treatment-related adverse events in 13% of patients and no Grade 4 or 5 events.
- Data were presented at AACR 2026 and represent a key milestone in validating zoldonrasib’s clinical potential.
Financial Impact
High-value potential in a niche but significant oncology market; ~2,500 new KRAS G12D NSCLC patients annually in the U.S. and ~61,000 across all cancers.
Risk Factors
- Phase 1 data may not translate to later-stage success.
- Competitive landscape could shift with other RAS inhibitors in development.
- Regulatory path remains uncertain without Phase 3 plans yet disclosed.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3276666 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 15, 2026 16d ago | 144 | $195.92 $190.74 | ▼ −2.64% | ▼ −5.21% | $206.29 (+5.29%) |
Sep 15, 2026 16d ago | 144 | $195.92 $190.74 | ▼ −2.64% | ▼ −5.21% | $206.29 (+5.29%) |
Sep 15, 2026 17d ago | Insider Cluster | $204.86 $190.95 | ▼ −6.79% | ▼ −7.61% | $206.29 (+0.70%) |
Sep 14, 2026 17d ago | Insider Cluster | $204.86 $192.86 | ▼ −5.86% | ▼ −7.98% | $206.29 (+0.70%) |
Aug 26, 2026 5w ago | 8-K | $215.44 $209.23 | ▼ −2.88% | ▼ −2.76% | $206.29 (−4.25%) |
Aug 26, 2026 5w ago | Press Release | $215.44 $209.23 | ▼ −2.88% | ▼ −2.76% | $206.29 (−4.25%) |
Aug 25, 2026 5w ago | Insider Cluster | $211.38 $209.87 | ▼ −0.71% | ▼ −0.18% | $206.29 (−2.41%) |
Jul 2, 2026 13w ago | Press Release | $189.24 $191.13 | ▲ +1.00% | ▲ +0.07% | $206.29 (+9.01%) |
Jul 1, 2026 13w ago | Insider Cluster | $187.51 $190.46 | ▲ +1.57% | ▲ +1.31% | $206.29 (+10.02%) |
Jun 22, 2026 14w ago | 8-K | $165.81 $192.62 | ▲ +16.17% | ▲ +16.62% | $206.29 (+24.41%) |
US Market Status
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