FDA issues psychedelic therapy guidance as Clearmind notes federal push

Clearmind Medicine Inc. (NASDAQ: CMND), a clinical-stage biotechnology company, issued a statement acknowledging recent U.S. federal regulatory developments related to psychedelic-based therapies for mental health and addiction treatment.

The developments include final FDA guidance on psychedelic clinical investigations, a planned public hearing on the therapeutic use of psychedelics, and new Memoranda of Understanding involving the U.S. Department of Health and Human Services, the Department of Veterans Affairs, the FDA, the National Institute on Drug Abuse, ARPA-H, and the Health Resources and Services Administration.

Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine, said: "At a time when patients in the veterans community and the general population have too few treatment options for intractable neuropsychiatric and addiction disorders, we are grateful that Secretary Kennedy is looking to transform treatment opportunities through the expansion of new therapeutic approaches."

Clearmind's lead drug candidate, CMND-100, also known as MEAI or 5-MeO-AI, is a non-hallucinogenic compound currently in FDA-cleared Phase I/IIa clinical trials for Alcohol Use Disorder. The trials are being conducted at Yale University and Johns Hopkins.

The company holds a portfolio of 19 patent families, including 32 granted patents.

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