Verastem Gains Fast Track for VS-7375 Lung Cancer Pill, Stock Jumps 5%
VSTM•Verastem Oncology’s shares rose 5% after hours as the FDA granted Fast Track designation for its oral KRAS G12D inhibitor VS-7375 in advanced non-small cell lung cancer. The drug, also fast-tracked for pancreatic cancer, targets both active and inactive KRAS G12D mutations across multiple ongoing trials.
1. FDA Fast Track Designation
The FDA granted Fast Track status to VS-7375 for advanced non-small cell lung cancer driven by the KRAS G12D mutation. This designation enables more frequent interactions with regulators and accelerates review timelines for patients lacking targeted therapies.
2. VS-7375 Mechanism and Trials
VS-7375 is an oral small molecule designed to inhibit the KRAS G12D protein in both its active and inactive states, a dual mechanism that may enhance tumor growth suppression. Verastem is conducting an early-phase study with initial data expected in H1 2026 and a mid-stage registration trial for patients with prior treatments and brain metastases.
3. Market Opportunity and Stock Reaction
KRAS G12D mutations occur in approximately 5% of NSCLC cases, representing over 8,000 U.S. patients annually who have limited options. Verastem’s stock climbed 5% post-market as investors responded to the accelerated development path for VS-7375.
