Psychedelic stocks gain after FDA priority review for MDMA therapy

Companies focused on psychedelic medicines traded higher on Monday after the FDA granted priority review for midomafetamine capsules (MDMA), which, if approved, could become the first psychedelic-assisted therapy.

Notable gainers include Mind Medicine (NASDAQ:MNMD), Mydecine Innovations (OTCPK:MYCOF), Numinus Wellness (OTCQX:NUMIF), Atai Life Sciences (NASDAQ:ATAI), COMPASS Pathways (NASDAQ:CMPS), 180 Life Sciences (ATNF), Enveric Biosciences (ENVB), Cybin (NYSE:CYBN), Seelos Therapeutics (SEEL), SciSparc (SPRC), Bright Minds Biosciences (DRUG), and Clearmind Medicine (CMND).

The new drug application submitted by San Jose, Calif.-based psychedelic biotech Lykos Therapeutics seeks approval of MDMA, commonly known as molly or ecstasy, for post-traumatic stress disorder (PTSD) in combination with other psychological interventions.

The FDA has set a target action date of August 11, 2024, for its review. “If approved, this would be the first MDMA-assisted therapy and psychedelic-assisted therapy,” Lykos said.

The company, previously known as MAPS PBC, launched in 2017 when it was spun out of its parent organization, MAPS (Multidisciplinary Association for Psychedelic Studies).

Optimi Health (OTCQX:OPTHF), a Canadian manufacturer focused on psychedelics, congratulated Lykos after the announcement. “This milestone marks a monumental leap forward in therapeutic research, providing much-needed solutions to those in dire need,” its CEO, Bill Ciprick, remarked.