Clearmind Advances Dialogue with U.S. Federal Government on Psychedelic Therapies, Submitting Recommendations to FDA

Company Calls for Consideration of New Regulatory Pathways and Cost Saving of Non-Hallucinogenic Neuroplastogens for Alcohol Use Disorder

Vancouver, Canada, Oct. 07, 2026 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (Nasdaq: CMND) (the “Company”), a clinical-stage biopharmaceutical company advancing non-hallucinogenic psychedelic-derived neuroplastogens for scalable treatment of neuropsychiatric, metabolic, and addiction disorders including Alcohol Use Disorder (“AUD”), today announced that it has submitted recommendations to the U.S. Food and Drug Administration (“FDA”) in response to the agency’s public hearing and request for comments on “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs.”

Under FDA Docket No. FDA-2026-N-7542, Clearmind’s recommendations focus on patient access and the potential future therapeutic use of psychedelic-derived non-hallucinogenic neuroplastogens. The Company highlights its clinical trials at Yale University and Johns Hopkins University, which have generated data suggesting that neuroplastogenic compounds that retain the therapeutic benefits of neuroplasticity enhancement while eliminating the hallucinogenic effects of legacy psychedelics may help mitigate the need for expensive supervised dosing.

Clearmind recommends that the FDA consider new guidance for self-administration, at-home-potential therapies, as well as streamlining regulatory pathways, expanding clinical trial access, leveraging Breakthrough Designation, and other measures intended to help bring urgently needed therapies to market. The Company also calls for additional research and clinical collaborations with the U.S. Department of Veterans Affairs (VA), U.S. Department of War (DoW), and U.S. Department of Health and Human Services (HHS) to help pilot safer, at-home-potential neuroplastogenic candidates for AUD and other indications.

“Clearmind has been dedicating substantial resources and effort to advancing awareness of non-hallucinogenic neuroplastogens and their potential role in addressing significant unmet needs in addiction and mental health,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “Our engagement with the U.S. federal government reflects our commitment to contributing to the dialogue around patient access, responsible development, and the potential future use of psychedelic-derived therapies. We believe that continued engagement with federal agencies, alongside rigorous clinical research, is important to advancing new treatment options for patients who currently have limited access to care.”