COGT Cogent Biosciences, Inc.
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Executive Summary
Cogent Biosciences announced FDA acceptance of its NDA for bezuclastinib in combination with sunitinib for GIST, with Priority Review and a PDUFA date of November 30, 2026. The Phase 3 PEAK trial showed a median PFS of 16.5 months vs 9.2 months (HR=0.50, p<0.0001) and a 46% ORR vs 26% for sunitinib alone. This is a major regulatory milestone for a first-in-class combination that could transform second-line GIST treatment, with no advisory committee planned and no identified review issues.
Actionable Insight
NDA acceptance with Priority Review and no AdCom is a strong positive signal. The PDUFA date of Nov 30, 2026 provides a clear catalyst. ASCO presentation on May 30 may drive near-term volatility. Monitor for any CRL or review issues ahead of PDUFA; the stock has historically underperformed post-reports (avg T+20 -6.73%), but this is a fundamentally different event — a regulatory acceptance with breakthrough designation and no identified issues.
Key Facts
- FDA accepted NDA for bezuclastinib + sunitinib in GIST with Priority Review; PDUFA date November 30, 2026
- Phase 3 PEAK trial: median PFS 16.5 months (combination) vs 9.2 months (sunitinib alone); HR=0.50 (95% CI: 0.39-0.65, p<0.0001)
- ORR 46% for combination vs 26% for sunitinib monotherapy in imatinib-resistant patients
- No advisory committee planned; FDA communicated no potential review issues identified
- Full PEAK results to be presented at ASCO oral session on May 30, 2026
- Company preparing for launches in both GIST and systemic mastocytosis later this year
- Expanded Access Programs established for U.S. patients with GIST or SM
Financial Impact
First approval for a novel KIT inhibitor combination in GIST; potential peak sales in the hundreds of millions to billions given GIST prevalence and clear superiority over standard of care
Risk Factors
- FDA could issue a Complete Response Letter at PDUFA despite current positive signals
- Hepatic safety signals (ALT/AST elevations) could become a review focus
- Commercial launch execution risk in both GIST and SM
- Overall survival data remains immature; negative OS readout could limit label expansion
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3302753 |
Filters
| Type | Now | ||||
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Jun 12, 2026
2d ago
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Press Release
| $32.61 awaiting T+5 | awaiting T+5 | — | $33.10 (+1.50%) |
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Jun 12, 2026
2d ago
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Press Release
| $32.61 awaiting T+5 | awaiting T+5 | — | $33.10 (+1.50%) |
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May 30, 2026
15d ago
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Press Release
| $34.81 $31.02 | ▼ −10.89% | ▼ −8.14% | $33.10 (−4.91%) |
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May 28, 2026
17d ago
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Press Release
| $35.38 $32.26 | ▼ −8.82% | ▼ −8.77% | $33.10 (−6.44%) |
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May 5, 2026
5w ago
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8-K
| $36.98 $34.10 | ▼ −7.79% | ▼ −9.77% | $33.10 (−10.49%) |
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Apr 17, 2026
8w ago
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Press Release
| $37.25 $36.81 | ▼ −1.18% | ▼ −1.74% | $33.10 (−11.14%) |
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Apr 1, 2026
10w ago
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Press Release
| $35.24 $37.35 | ▲ +5.99% | ▲ +2.22% | $33.10 (−6.07%) |
US Market Status
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