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MindMed Receives Breakthrough Therapy Designation From FDA For LSD

March 7, 2024
x min read

The FDA has given yet another Breakthrough Therapy designation to a psychedelic drug developer. And this time, it’s for LSD.

What’s happening:

  • Psychedelic biotechnology company MindMed (NASDAQ: MNMD) has received a Breakthrough Therapy designation from the United States FDA for their novel drug MM120 for General Anxiety Disorder
  • This is the first time the FDA has ever given a Breakthrough Therapy designation for a LSD derived therapeutic

Market reaction:

  • Shares of MindMed were up more than +51% following their announcement of receiving Breakthrough Therapy designation from the FDA

Why it matters:

  • Breakthrough Therapy designations from the FDA are difficult to obtain for new therapeutics and are reserved for drugs that have clearly demonstrated clinical efficacy for treating serious unmet medical needs
  • Psychedelic medicines and psychedelic assisted therapies are closer than ever to full regulatory approvals in North America, with the FDA recently announcing they will soon be making a decision on officially approving MDMA assisted therapy as a treatment for PTSD

By the numbers:

  • New clinical trial data from MindMed shows that 48% of patients showed remission from General Anxiety Disorder after just 1 dose of MM120
  • Throughout all of MindMed’s clinical trial research, over 10,000 individuals have now been dosed with MM120

Going deeper:

  • There are now multiple psychedelic drug developers who have earned a Breakthrough Therapy designation from the FDA, including COMPASS Pathways (NASDAQ: CMPS) for their synthetic psilocybin and Lykos Therapeutics for MDMA assisted therapy

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