The FDA granted Fast Track designation to Autobahn Therapeutics’ elunetirom (ABX-002) for adjunctive treatment of depressive episodes associated with bipolar I or bipolar II disorder in adults. Autobahn said the designation supports more frequent FDA interactions and, if criteria are met later, could make the program eligible for expedited review pathways. Elunetirom is an investigational once-daily oral small-molecule prodrug intended to penetrate the central nervous system and activate CNS thyroid hormone receptors while limiting peripheral thyroid receptor effects. The company is evaluating the candidate in the AMPLIFY-BD Phase 2 trial. Autobahn said topline data from AMPLIFY-BD remain expected in the second quarter of 2026, and the Fast Track news did not include new efficacy or safety results.