Autobahn Therapeutics received FDA Fast Track designation for elunetirom (ABX-002) as adjunctive treatment for bipolar depression. The company said the designation is intended to increase the frequency of FDA interactions and could make the program eligible for expedited review pathways if later criteria are met. Elunetirom is being studied as a once-daily oral prodrug designed to penetrate the central nervous system and activate CNS thyroid hormone receptors while limiting peripheral receptor effects. The agent is being evaluated in AMPLIFY-BD, a Phase 2 trial in adults with bipolar I/II depression. Autobahn said topline data from AMPLIFY-BD are expected in Q2 2026, and no new efficacy or adverse-event results were included with the Fast Track announcement.