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Companies focused on psychedelic drugs traded higher on Thursday after Mind Medicine (NASDAQ:MNMD) said that the U.S. FDA issued breakthrough therapy designation for its LSD formulation, MM120 (lysergide d-tartrate).
A coveted regulatory program for therapeutic candidates in the U.S., the breakthrough designation can speed up MM120’s development for generalized anxiety disorder (GAD), potentially enabling Mind Medicine (MNMD) to receive priority review for the drug.
After the announcement, MNMD stock surged ~55% to reach a new 52-week high, as 21.5M shares changed hands compared to the 65-day average of 774.9K.
Its rivals in the psychedelic space, Seelos Therapeutics (NASDAQ:SEEL), Clearmind Medicine (NASDAQ:CMND), Bright Minds Biosciences (NASDAQ:DRUG), Numinus Wellness (OTCQX:NUMIF), Atai Life Sciences (ATAI), Enveric Biosciences (ENVB), SciSparc (SPRC), and Cybin (CYBN), are also among notable gainers.
Revive Therapeutics (OTCQB:RVVTF), whose psychedelic-derived compound psilocin is under investigation for anxiety and other psychiatric conditions, lost ~12%.
Meanwhile, Roth Capital Partners lifted its price target on MNMD to $36, citing FDA breakthrough status and new results the company shared from a Phase 2b trial for MM120 in GAD on Thursday.
While potent hallucinogens require hours of patient supervision after dosing, new data indicating clinically and statistically significant durability of MM120 at Week 12 will help the company develop the drug with a lower dosing frequency, Roth said.
In December, the company announced that the trial met the main goal at Week 4.
