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FDA approval
MindMed receives FDA breakthrough designation for MM120 program
Psychedelic Medicine
Mar 7, 2024
Older updates:
Funding
MindMed secures USD 175 million via underwritten offering and private placement
Psychedelic Medicine
Mar 7, 2024
Funding
MindMed secures USD 50 million in credit facility
Psychedelic Medicine
Aug 14, 2023
Partnerships
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Product updates
Numinus’ Cedar Clinical Research site to be used in MindMed's Phase IIb study on MM-120
Psychedelic Medicine
Jun 5, 2023
Earnings/results
MindMed provides financial and business update for Q1 2023; losses deepen
Psychedelic Medicine
May 4, 2023
Management news
MindMed provides corporate update with its plan for 2023
Psychedelic Medicine
Jan 9, 2023
Earnings/results
MindMed provides financial and business update for Q3 2022
Psychedelic Medicine
Nov 10, 2022
Funding
MindMed announces underwritten public offering
Psychedelic Medicine
Sep 27, 2022
Earnings/results
MindMed reports clinical trials progress; expects Phase IIb results in 2023
Psychedelic Medicine
Aug 11, 2022
Earnings/results
Mindmed to launch three Phase I/II clinical trials in 2022
Psychedelic Medicine
May 16, 2022
Psychedelic Medicine

Psychedelic Medicine

View industry hub
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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