Tangram Therapeutics submitted a clinical trial application to the U.K. Medicines and Healthcare products Regulatory Agency to initiate a Phase I/II study of TGM‑312 for metabolic dysfunction‑associated steatohepatitis (MASH). The CTA sets the stage for first‑in‑human testing of Tangram’s candidate in a disease with high unmet need and limited approved options. Tangram plans to assess safety, dosing and early signals of efficacy in the combined Phase I/II design. The company emphasized the need to generate translational biomarkers and histologic endpoints consistent with regulatory expectations for NASH/MASH programs. If cleared, the trial will provide early human data on target engagement and guide dose selection for larger efficacy studies; the MASH field remains capital‑intensive and competitive, increasing the importance of rapid go/no‑go decision points.