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Mar 7, 2024
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Psychedelic Medicine

Psychedelic Medicine

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Mar 7, 2024

MindMed receives FDA breakthrough designation for MM120 program

FDA approval

  • New York-based psychedelic biotech company MindMed has received a breakthrough designation from the FDA for its MM120 (lysergide d-tartrate) program to treat generalized anxiety disorder (GAD). MM120 is a synthetic drug belonging to the class of serotonergic psychedelics.

  • The company also announced positive results from the Phase IIb study of MM120 in GAD and plans to initiate Phase III clinical trials during the second half of 2024. 

  • Analyst QuickTake: With this, the company joins its industry counterparts, Lykos Therapeutics (formerly MAPS) and Compass Pathways, which has also obtained FDA breakthrough designations. Lykos Therapeutics received approval for MDMA-assisted therapy to treat PTSD in August 2017 , while Compass Pathways received it for psilocybin-assisted therapy for treatment-resistant depression in October 2018 .

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