Grandbrothers/iStock Editorial via Getty Images Leading developers of psychedelic medicines traded lower in the premarket on Wednesday after a panel of independent advisors to the U.S. FDA declined to endorse marketing authorization for psychiatric therapy, midomafetamine (MDMA), also known as ecstasy.
Notable decliners include Mind Medicine ( NASDAQ: MNMD ), Atai Life Sciences ( NASDAQ: ATAI ), COMPASS Pathways ( NASDAQ: CMPS ), and Cybin ( NYSE: CYBN ). The selloff comes after the FDA's Psychopharmacologic Drugs Advisory Committee on Tuesday voted overwhelmingly against approving the marketing application submitted by Lykos Therapeutics for MDMA targeting post- traumatic stress disorder (PTSD). "It seems like there are so many problems with the data - each one alone might be okay, but when you pile them on top of each other, there's just a lot of questions still I would have about how effective the treatment is," panel member Melissa Barone, who voted against the drug, said.
The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations, which in the case of MDMA is expected on or before Aug. 11.
If approved, MDMA will be the first FDA-authorized psychedelic-assisted therapy, a major catalyst for the industry. Other biopharma firms focused on psychedelics include GH Research ( GHRS ), 180 Life Sciences ( ATNF ), Numinus Wellness ( OTCQX:NUMIF ), Revive Therapeutics ( OTCQB:RVVTF ).
