secwatch.observer — SEC 8-K summary
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Issuer:     Verastem, Inc. (VSTM)
CIK:        0001526119
Form:       8-K
Filed at:   2025-05-08T23:59:59+00:00
Accession:  0001104659-25-046175
Event type: regulatory
Sentiment:  positive
Materiality: 0.95
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1526119/000110465925046175/0001104659-25-046175-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1526119/000110465925046175/tm2514525d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-046175

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer