Verastem Oncology Receives FDA Clearance for Investigational New Drug Application for Cancer Treatment

VSTM

By Connor Hart

Verastem Oncology said Wednesday that the Food and Drug Administration cleared the company's investigational new drug application for its potential treatment of certain cancers.

The biopharmaceutical company now plans to initiate a Phase 1/2a study for the treatment, VS-7375, in mid-2025. The study has plans for multiple expansion cohorts, including combinations, in advanced solid tumors, such as pancreatic cancer, colorectal cancer, and non-small cell lung cancer, the company said.

"We're excited to advance the clinical program for VS-7375 in the U.S. and build on the initial dose escalation work conducted by GenFleet in China that demonstrated oral bioavailability and no dose-limiting toxicities across six dose levels, with partial responses achieved among multiple patients with both pancreatic and advanced lung cancers," Chief Executive Dan Paterson said.

Shares rise 1.4% in after-hours trading, to $7.22.

Write to Connor Hart at [email protected]

(END) Dow Jones Newswires

04-23-25 1718ET