AXSM · Axsome Therapeutics, Inc.

Axsome Therapeutics has entered into an asset purchase agreement with Takeda to acquire exclusive global rights to balipodect (TAK-063), a novel, oral, potent, and selective phosphodiesterase 10A (PDE10A) inhibitor. This acquisition strategically expands Axsome's central nervous system (CNS) portfolio with a potentially first-in-class mechanism of action targeting neuropsychiatric conditions. The company intends to develop the inhibitor for the treatment of schizophrenia and Tourette syndrome, with plans to initiate Phase 3 trial-enabling activities for the schizophrenia indication in 2026. Balipodect has already completed a 164-patient proof-of-concept Phase 2 trial in schizophrenia and has demonstrated a favorable safety and tolerability profile in clinical studies involving over 360 individuals to date. Under the terms of the agreement, Axsome obtained worldwide commercial, development, and manufacturing rights. Takeda received an upfront payment and is eligible to receive additional payments related to development, regulatory, and commercial milestones for the first two indications, as well as royalties related to potential global net sales. CEO Herriot Tabuteau highlighted that the molecule complements the company's pipeline as they continue to develop differentiated treatment options for brain health.