Makhbubakhon Ismatova The journal Psychopharmacology on Aug. 10 retracted three articles related to the use of MDMA for PTSD, the day after the U.S.
FDA rejected the use of the psychedelic drug for the condition. Scientists who worked on the pieces are affiliated with the Multidisciplinary Association for Psychedelic Studies, which incubated Lykos Therapeutics, the company behind midomafetamine, the drug that was rejected. Lykos CEO Amy Emerson is a co-author.
Psychopharmacology cited protocol violations as well as failing to disclose potential conflict of interests in its retraction notice . Separately, nearly all publicly traded companies involved in developing medicines based on psychedelic drugs are down in Monday trading following the FDA's decision. Among larger developers, Cybin ( NYSE: CYBN ) has been the worst hit, down ~4% .
The company is developing psilocybin, the active ingredient in "magic mushrooms," as well as deuterated dimethyltryptamine as treatments for various psychiatric illnesses. Among microcaps, Bright Minds Biosciences has the biggest decline, down ~8% . In issuing its Complete Response Letter to Lykos, the FDA said a resubmission would require results from an additional phase 3 trial for garner additional efficacy and safety data.
A potential worry for psychedelic drug developers was the concern over trials raised by FDA scientists in briefing documents provided for a June advisory committee meeting to discuss midomafetamine. This included how trials of psychedelic-based drugs could be truly blinded, given their effect on mood and cognition. Publicly traded psychedelic-focused drug developers include Mind Medicine ( NASDAQ: MNMD ), Atai Life Sciences ( NASDAQ: ATAI ), COMPASS Pathways ( NASDAQ: CMPS ), and GH Research ( GHRS ).
Nano-caps include 180 Life Sciences ( ATNF ), Enveric Biosciences ( ENVB ), Seelos Therapeutics ( SEEL ), SciSparc ( SPR ), Bright Minds Biosciences ( DRUG ), and Clearmind Medicine ( CMND ). More on psychedelic drug developers MindMed And Other Psychedelic Stocks Brace For FDA's Decision On MDMA Therapy Compass Pathways: Buy It For Its Promising Psychedelic Mental Health Therapies Mind Medicine prices $75M securities offering Mind Medicine stock dips on proposed securities offering COMPASS Pathways plc (CMPS) Q2 2024 Earnings Call Transcript.
