---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-046175"
form_type: "8-K"
ticker: "VSTM"
cik: "0001526119"
company_name: "Verastem, Inc."
filed_at: "2025-05-08T23:59:59+00:00"
generated_at: "2026-05-22T04:06:25.089745+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# FDA approves Verastem's AVMAPKI FAKZYNJA for KRAS-mutated recurrent LGSOC

## Summary
- First-ever FDA-approved treatment for KRAS-mutated recurrent LGSOC; accelerated approval based on Phase 2 RAMP 201.
- RAMP 201 showed 44% overall response rate (BIRC) in 57 patients; median duration of response range 3.3–31.1 months.
- Approval granted May 8, 2025, ahead of the June 30 PDUFA date; continued approval contingent on confirmatory trial.
- AVMAPKI FAKZYNJA CO-PACK expected to be commercially available in the U.S. within one week.
- Verastem to host investor call at 2:30 pm ET today to discuss the approval.

## SEC filing metadata
- accession: 0001104659-25-046175
- form_type: 8-K
- ticker: VSTM
- cik: 0001526119
- company_name: Verastem, Inc.
- filed_at: 2025-05-08T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1526119/000110465925046175/0001104659-25-046175-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1526119/000110465925046175/tm2514525d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-046175
- JSON: https://secwatch.observer/filing/0001104659-25-046175.json
- Plain text: https://secwatch.observer/filing/0001104659-25-046175.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.