Traders should watch for the full primary analysis data from the PYNNACLE trial at a medical conference in Q4 2026 and the NDA submission in Q1 2027. Positive data could drive significant upside given the $65M market cap, but binary regulatory risk remains.
Price Chart
Executive Summary
PMV Pharmaceuticals announced updated interim Phase 2 data for rezatapopt in platinum-resistant/refractory ovarian cancer, showing a 46% ORR (35/76 evaluable patients) with a median duration of response of 10.0 months. The FDA has provided feedback supporting an NDA submission for accelerated approval, planned for Q1 2027. This is a significant positive catalyst for the company's lead asset.
Key Facts
- 46% overall response rate (ORR) among 76 evaluable patients in the ovarian cancer cohort
- Median duration of response of 10.0 months based on confirmed responses
- FDA feedback supports NDA submission strategy for accelerated approval
- NDA submission planned for first quarter of 2027
- Enrollment for primary analysis in ovarian cancer cohort completed
- Full PYNNACLE Phase 2 cohort data update expected at a medical conference in Q4 2026
Financial Impact
Potential for accelerated approval in platinum-resistant/refractory ovarian cancer with TP53 Y220C mutation; no financial figures disclosed in filing
Risk Factors
- FDA may require additional data or deny accelerated approval
- Competition from other p53-targeting therapies or standard-of-care treatments
- Clinical trial results may not replicate in larger populations
- Company has limited cash runway and may need to raise capital
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-376723 |
| Document: d441751dex991.htm | 0001193125-26-376723 |
| Document: 0001193125-26-376723-index-headers.html | 0001193125-26-376723 |
| Document: 0001193125-26-376723-index.html | 0001193125-26-376723 |
| Document: 0001193125-26-376723.txt | 0001193125-26-376723 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 5, 2026 21d ago | 8-K | $1.78 | awaiting T+20 | — | $1.13 (−36.52%) |
Aug 31, 2026 7w ago | Press Release | $1.29 $1.67 | ▼ −29.46% | ▼ −29.14% | $1.13 (+12.40%) |
Aug 31, 2026 8w ago | 8-K | $1.29 $1.67 | ▲ +29.46% | ▲ +29.14% | $1.13 (−12.40%) |
Aug 31, 2026 8w ago | Press Release | $1.29 $1.67 | ▼ −29.46% | ▼ −29.14% | $1.13 (+12.40%) |
Aug 31, 2026 8w ago | Press Release | $1.29 $1.67 | ▲ +29.46% | ▲ +29.14% | $1.13 (−12.40%) |
Aug 14, 2026 10w ago | 8-K | $1.26 $1.46 | ▲ +15.87% | ▲ +17.86% | $1.13 (−10.32%) |
Aug 14, 2026 10w ago | Press Release | $1.26 $1.46 | ▲ +15.87% | ▲ +17.86% | $1.13 (−10.32%) |
May 12, 2026 23w ago | 8-K | $1.42 $1.06 | ▼ −25.35% | ▼ −23.62% | $1.13 (−20.42%) |
May 12, 2026 23w ago | Press Release | $1.42 $1.06 | ▼ −25.35% | ▼ −23.62% | $1.13 (−20.42%) |
Apr 22, 2026 26w ago | DEFA14A | $1.48 $1.31 | ▼ −11.49% | ▼ −14.65% | $1.13 (−23.65%) |
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.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers