Axsome Therapeutics said it has acquired exclusive global rights to balipodect, a selective PDE10A inhibitor, in a move that expands its CNS pipeline into schizophrenia and Tourette syndrome.
Balipodect has already completed a 164-patient phase 2 proof-of-concept trial in schizophrenia. Axsome said the drug has been studied in more than 360 people overall and has shown a favorable safety and tolerability profile to date.
The company plans to start phase 3 trial-enabling work for schizophrenia in 2026. Under the agreement, Axsome gained worldwide commercial, development and manufacturing rights. Takeda received an upfront payment and could receive additional development, regulatory and commercial milestone payments tied to the first two indications, plus royalties on future global net sales.
Axsome said schizophrenia affects about 3.7 million people in the U.S. and is one of the leading causes of disability worldwide. The company described balipodect as a potentially first-in-class mechanism and said it is also targeting Tourette syndrome. The market has reacted to these announcements by moving the company's shares 1.54% to a price of $164.265. For more information, read the company's full 8-K submission here.
