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FDA approval

MindMed receives FDA breakthrough designation for MM120 program

Psychedelic Medicine

Mar 7, 2024

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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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