secwatch.observer — SEC 8-K summary
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Issuer:     Verastem, Inc. (VSTM)
CIK:        0001526119
Form:       8-K
Filed at:   2024-04-09T23:59:59+00:00
Accession:  0001104659-24-045266
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Verastem outlines NDA filing plan for avutometinib/defactinib in LGSOC by H1 2024; cash $137.1M
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- Topline data from RAMP 201 trial of avutometinib + defactinib in LGSOC expected H1 2024; rolling NDA for accelerated approval to commence same period.
- Confirmed ORR of 45% with tumor shrinkage in 86% of evaluable patients from RAMP 201 Part A (June 2023 data).
- GenFleet partnership: IND for oral KRAS G12D inhibitor GFH375/VS-7375 expected in China H1 2024; Phase 1 initiation H2 2024.
- Initial safety/efficacy data from RAMP 205 (avutometinib + gemcitabine/nab-paclitaxel + defactinib) in front-line metastatic pancreatic cancer due H1 2024.
- Ended Q4 2023 with $137.1M cash; GAAP operating expenses $31.14M ($29.54M non-GAAP) in Q4 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1526119/000110465924045266/0001104659-24-045266-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1526119/000110465924045266/tm2411327d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-045266

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