Verastem outlines NDA filing plan for avutometinib/defactinib in LGSOC by H1 2024; cash $137.1M

Verastem, Inc.

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.

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