Verastem

The global MEK inhibitors market, valued at $995.1M in 2023, is projected to reach $1.5B by 2030, driven by cancer prevalence, genomics discoveries, clinical trial expansions, diagnostic advancements, and regulatory incentives.

The FDA has completed the rolling NDA for avutometinib and defactinib, targeting recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC). The combination, granted orphan drug designation, aims to address the unmet need for specific LGSOC treatments. Preliminary data from the FRAME and RAMP 201 trials indicate a 44% ORR and 22-month median PFS in KRAS mutant LGSOC patients, with ongoing enrollment for the RAMP 301 phase 3 trial. Verastem Oncology anticipates potential FDA approval by mid-2025.

Verastem, Inc. (VSTM) develops cancer treatments targeting the RAS/MAPK pathway, focusing on pancreatic, lung, colorectal, and low-grade serous ovarian cancers. Its leading therapy combines Avutometinib and Defactinib, with a rolling NDA submission expected to finalize by 2H2024 for recurrent LGSOC. VSTM also explores additional indications for metastatic pancreatic cancer and mKRAS G12C NSCLC. The company's tight cash runway makes it a high-risk, high-reward investment, but its current valuation and pathway to approval suggest a bullish outlook.