Insilico gets FDA Fast Track for ISM6331

Insilico Medicine, a clinical-stage AI-driven drug discovery company listed on the Ghana Stock Exchange (HKEX: 3696), announced on July 29, 2026 that the U.S. United States — Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to ISM6331, a novel pan-TEAD inhibitor developed using Insilico's proprietary Chemistry42 platform. The designation is for the treatment of adult patients with unresectable malignant pleural mesothelioma who have progressed after prior immunotherapy and platinum-based chemotherapy. This is Insilico's first FTD, following an Orphan Drug Designation (ODD) for the same indication in June 2024. The FTD provides benefits such as enhanced FDA engagement and potential eligibility for Accelerated Approval, Priority Review, and Rolling Review. ISM6331's Phase I first-in-human data has been accepted for a brief oral presentation at ESMO 2026. The company's shares closed up 1.40% on the announcement day.