secwatch.observer — SEC 8-K summary
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Issuer:     Verastem, Inc. (VSTM)
CIK:        0001526119
Form:       8-K
Filed at:   2024-07-23T23:59:59+00:00
Accession:  0001104659-24-081882
Event type: other_material
Sentiment:  positive
Materiality: 0.55
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Verastem initiates rolling NDA for avutometinib/defactinib; RAMP 201 median duration 9 months
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- Rolling NDA for avutometinib+defactinib in recurrent KRAS mutant LGSOC started May 2024; priority review requested.
- RAMP 201 interim data (Feb 2024 cutoff): median duration 9 months; KRAS mt 14 months, KRAS wt 7 months; 31/58 KRAS mt still on treatment.
- Estimated addressable market: annual ~$300M KRAS mt, ~$270M KRAS wt; prevalent ~$1.7B KRAS mt, ~$1.1B KRAS wt based on $34k/month cost.
- GenFleet collaboration: IND cleared June 2024, first patient dosed in China Phase 1/2 for KRAS G12D inhibitor GFH375/VS-7375.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1526119/000110465924081882/0001104659-24-081882-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1526119/000110465924081882/tm2413643d3_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-081882

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