The VS-7375 data across PDAC, NSCLC, and CRC are among the strongest reported for any KRAS G12D inhibitor, with 900mg QD showing best-in-class efficacy and tolerability. The FDA-aligned Phase 3 PDAC trial opening by year-end, termination of the ATM (removing dilution risk), and a well-capitalized balance sheet ($172.8M cash) create a clean catalyst path. Watch for: (1) mature CRC 900mg combo data by year-end, (2) FDA meeting for NSCLC/CRC Phase 3 designs, (3) initial Phase 2 PDAC data in Q2 2027.
Price Chart
Executive Summary
Verastem reported preliminary Q3 2026 net product revenue of ~$23.9-24.1M (vs $11.2M YoY), announced CEO Dan Paterson's planned retirement effective Jan 1, 2027 with Michael Bailey as successor, and disclosed compelling Phase 1/2 data for VS-7375 showing 41% confirmed ORR in 2L+ PDAC, 43% in 2L+ NSCLC, and FDA alignment on a Phase 3 1L mPDAC trial. The company also terminated its ATM prospectus (no shares sold) and received FDA priority review for its Blister Pack NDA. The combination of strong commercial growth, best-in-class clinical data, and a clean capital structure is highly bullish.
Key Facts
- Preliminary Q3 2026 net product revenue estimated at $23.9-24.1M, more than doubling from $11.2M in Q3 2025
- Cash and investments of $172.8M as of Sep 30, 2026, up from $137.7M a year earlier
- VS-7375 900mg QD monotherapy achieved 41% confirmed ORR (9/22) in 2L+ PDAC, including 2 complete responses; 50% confirmed ORR in 2L PDAC (4/8)
- VS-7375 600mg QD achieved 43% confirmed ORR (10/23) in 2L+ NSCLC; 75% ORR (6/8) in 1L NSCLC with triplet SOC
- FDA alignment reached on Phase 3 TARGET-D 301 trial design in 1L mPDAC; trial expected to open by year-end 2026
- CEO Dan Paterson to retire Jan 1, 2027; Michael Bailey (former AVEO CEO) appointed as successor; Paterson remains on board and as advisor
- ATM prospectus terminated; no shares sold under the facility — removes future dilution overhang
- FDA accepted Blister Pack NDA for priority review, expected in Q1 2027
- VS-7375 safety profile at 900mg: 2% AE-related discontinuation rate, 97% relative dose intensity, no Grade 4/5 TRAEs
Financial Impact
Q3 2026 net product revenue ~$23.9-24.1M, more than double Q3 2025's $11.2M; cash position $172.8M vs $137.7M YoY
Risk Factors
- Phase 3 PDAC trial (TARGET-D 301) may fail to confirm Phase 1/2 efficacy signals
- Competition from other KRAS G12D inhibitors (daraxonrasib, zoldonrasib, INCB161734) could erode market opportunity
- CEO transition creates execution risk during critical Phase 3 launch period
- Preliminary Q3 revenue is unaudited and subject to revision
- Reliance on single drug (VS-7375) for pipeline value; AVMAPKI/FAKZYNJA commercial trajectory still early
Investment Themes
Documents Analyzed
This report is based on 8 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001104659-26-115687 |
| Document: tm2627537d4_8k.htm | 0001104659-26-115687 |
| Document: tm2627537d4_ex99-2.htm | 0001104659-26-115687 |
| Document: tm2627537d4_ex99-1.htm | 0001104659-26-115687 |
| Document: 0001104659-26-115687-index-headers.html | 0001104659-26-115687 |
| Document: 0001104659-26-115687-index.html | 0001104659-26-115687 |
| Document: 0001104659-26-115687.txt | 0001104659-26-115687 |
| 8-K Data (Synthetic) | 0001104659-26-115687 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 14, 2026 11d ago | 8-K | $9.23 | awaiting T+60 | — | $9.92 (−7.48%) |
Oct 14, 2026 11d ago | 424B5 | $9.23 | awaiting T+60 | — | $9.92 (−7.48%) |
Oct 14, 2026 11d ago | 424B5 | $9.23 | awaiting T+60 | — | $9.92 (−7.48%) |
Oct 14, 2026 12d ago | 8-K | $7.71 | awaiting T+60 | — | $9.92 (+28.67%) |
Oct 2, 2026 23d ago | Insider Cluster | $8.00 | awaiting T+60 | — | $9.92 (−24.01%) |
Jun 23, 2026 17w ago | 8-K | $3.85 $7.55 | ▲ +96.10% | ▲ +93.27% | $9.92 (+157.68%) |
Jun 17, 2026 18w ago | 8-K | $4.17 $7.32 | ▲ +75.54% | ▲ +72.39% | $9.92 (+137.90%) |
Jun 11, 2026 19w ago | Institutional Cluster | $4.10 $8.08 | ▲ +97.07% | ▲ +93.81% | $9.92 (+141.97%) |
Jun 11, 2026 19w ago | Institutional Cluster | $3.94 $8.20 | ▲ +108.12% | ▲ +103.73% | $9.92 (+151.79%) |
May 27, 2026 21w ago | 3 | $4.29 $6.89 | ▲ +60.61% | ▲ +58.87% | $9.92 (+131.25%) |
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