Autobahn Therapeutics received FDA Fast Track designation for elunetirom (ABX-002) as an adjunctive treatment for depressive episodes in adults with bipolar I or bipolar II disorder. The designation may allow more frequent FDA interactions and, if criteria are met later, eligibility for expedited review pathways. Elunetirom is an oral small-molecule prodrug intended to penetrate the central nervous system and activate CNS thyroid hormone receptors while aiming to limit peripheral thyroid effects. Autobahn is evaluating the drug in the AMPLIFY-BD Phase 2 study; topline results are still expected in the second quarter of 2026. Fast Track does not imply approval or establish efficacy, but it places the program in an accelerated regulatory track at an early-to-mid clinical stage.
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