The FDA granted Fast Track designation to Insilico Medicine’s ISM6331, an investigational pan-TEAD inhibitor being developed for adult patients with unresectable malignant pleural mesothelioma following progression on or after anti–PD-1 therapy. Insilico said the designation also covers patients treated with or without anti–CTLA-4 therapy and with or without platinum-based chemotherapy. The company plans to present first-in-human Phase 1 data for ISM6331 at ESMO 2026, positioning the program as an additional Hippo-pathway modulating option in a setting where new mechanisms are urgently sought after immunotherapy progression. Fast Track designation can enable more frequent interactions with FDA and may support expedited development plans depending on the overall clinical strategy. For the AI drug-discovery space, ISM6331 adds another regulatory milestone that demonstrates how computationally designed candidates are increasingly reaching early clinical pathways with FDA-aligned development support.