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Psychedelics have long been seen as the potential next big breakthrough in biotech. But for the first time ever, psychedelic therapeutics are finally getting closer to being approved drugs.
What’s happening:
- Psychedelic drug developers have been on a rapid rise lately, with multiple new Breakthrough Therapy designations from the FDA being announced and recent significant venture capital raises
Why it matters:
- Psychedelic medicines have seen overwhelming evidence for therapeutic potential in research experiments and university led studies, but have not yet had a formal drug approval in North America
- With recent announcements from the FDA, psychedelic medicines are now closer than ever to being officially cleared to administer and prescribe to patients
Who is making moves:
- MindMed (NASDAQ: MNMD) recently was granted Breakthrough Therapy designation by the FDA for their LSD derived molecule for General Anxiety Disorder
- Cybin (NYSE: CYBN) recently was granted Breakthrough Therapy designation by the FDA for their deuterated psilocybin analogue for Major Depressive Disorder
- Gilgamesh recently was awarded a $14M USD grant from the National Institute on Drug Abuse to accelerate the clinical development of their ibogaine derived molecule for opioid addiction and substance abuse
Going deeper:
- Lykos Therapeutics, which was formerly the MAPS Public Benefit Corporation, recently raised $100M USD in venture capital funding to prepare to commercialize MDMA assisted therapy for PTSD
- The FDA has given Lykos a Priority Review which means they have committed to fast tracking their decision on an official approval for MDMA assisted therapy
- Prior to the recent announcements from Cybin and MindMed, COMPASS Pathways (NASDAQ: CMPS) was the only publicly traded psychedelic biotechnology company to have a Breakthrough Therapy designation from the FDA
