Clearmind Medicine Inc (CMND) News & EventsCMNDClearmind Medicine Inc

Clearmind Submits Recommendations to FDA for Psychedelic Drug Therapy

Clearmind Medicine announced it submitted recommendations to the FDA under Docket FDA-2026-N-7542 on future therapeutic use of psychedelic drugs, urging guidance for self-administration and at-home potential non-hallucinogenic neuroplastogens for alcohol use disorder and streamlined pathways including Breakthrough Designation. The clinical-stage biotech cites Yale and Johns Hopkins trial data suggesting neuroplastogens can keep therapeutic benefits without hallucinogenic effects that drive supervised dosing costs, and calls for more work with Veterans Affairs, the Department of War and Health and Human Services. "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 Adi Zuloff-Shani, CEO.

Psyence Biomedical Secures Exclusive U.S. Ibogaine License

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a license agreement, a psilocybin shipment and a reverse share split.PSYENCE BIOMED REPORTS EXCLUSIVE U.S. IBOGAINE LICENSE:Psyence Biomedicalannounced Monday that its wholly-owned subsidiary, Texas Ibogaine Research Corporation, has entered into a binding term sheet with Psyence Labs, under whichfor PsyLabs' pharmaceutical-grade ibogaine in the United States. The term sheet is binding on the parties and is to be superseded by a definitive agreement, which the parties have agreed to conclude on or before November 30; if a definitive agreement is not signed by that date, the term sheet will lapse.Under the term sheet, PsyLabs will grant TIRC an exclusive license in the U.S. to PsyLabs' know-how, trade secrets, cultivation, extraction and processing methods, analytical methods, specifications, standard operating procedures, batch records and technical and regulatory information relating to its pharmaceutical-grade ibogaine hydrochloride, to the extent necessary or useful to develop, manufacture and commercialize ibogaine drug candidates in the U.S. PsyLabs will be TIRC's exclusive supplier of ibogaine, and TIRC will be appointed PsyLabs' exclusive wholesaler and distributor of that product in the U.S. PsyLabs retains all rights outside the U.S. In consideration, TIRC will pay PsyLabs development and regulatory milestone payments totaling up to approximately $1.3M for the first drug candidate, an annual exclusivity fee commencing on the first anniversary of the first FDA approval and creditable against royalties, and a low single-digit percentage royalty on net sales of each drug candidate, together with a margin-sharing arrangement on any resale of product by TIRC."Exclusivity matters. This term sheet is intended to give TIRC a defined position in U.S. ibogaine development, backed by access to PsyLabs' material, manufacturing know-how and technical documentation. For any federal agency, state programme or clinical partner, we believe that the question of who to work with on ibogaine in the USA has a clear answer," said Jody Aufrichtig, CEO of Psyence BioMed.FILAMENT SHIPS PEX010 TO UNIVERSITY OF CALGARY:Rhelion Life Sciencesannounced Tuesday that subsidiary Filament Health has shippedfor the Phase 2 trial titled "Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence", known as PsiPTSD. PsiPTSD will evaluate psilocybin-assisted therapy for chronic PTSD in adult survivors of intimate partner violence. The trial is led by Dr. Chantel Debert at the University of Calgary. The University of Calgary is the sponsor of the trial. Filament is not the sponsor of the trial and is not responsible for its conduct. PsiPTSD is the second trial led by Dr. Debert at the University of Calgary to use PEX010, following a Phase 2b trial of psilocybin-assisted therapy for persisting symptoms after concussion.The company also announced Friday that Filament has expanded its supply and licence agreement with the University G. d'Annunzio of Chieti-Pescara for the supply of PEX010 to TEMPO, a clinical trial of psilocybin for treatment-resistant depression conducted at the Psychiatric Clinic of the University in Chieti, Italy. TEMPO was authorized under the European Union Clinical Trials Regulation. During the regulatory review, the number of trial participants was increased, and the amended agreement expands the supply of PEX010 25 mg capsules to match. Filament also provides regulatory support for the trial and release of PEX010 for use in the European Union. The trial is coordinated with the Istituto Superiore di Sanità and has been reported in the Italian press as the first clinical trial of psilocybin in Italy.CLEARMIND TO EFFECT REVERSE SHARE SPLIT:In a Wednesday regulatory filing, Clearmind Medicineannounced that it will effect asuch that each eight common shares, no par value, shall be consolidated into one common share, no par value. The first date when the company's ordinary shares will begin trading on the Nasdaq Capital Market after implementation of the reverse split will be Monday, October 5. Following the implementation of the reverse split, the company's authorized share capital will remain unchanged. The reverse split will adjust the number of issued and outstanding common shares of the company from 4,059,227 ordinary shares to 507,404 ordinary shares.HELUS PHARMA COMPLETES LEGAL NAME CHANGE:Helus Pharmaannounced Thursdayfrom "Cybin Inc." to "Helus Pharma Inc." The name change was approved by shareholders at the company's annual and special meeting of shareholders held on September 22. The name change follows the company's adoption of the business name "Helus Pharma" on January 5 and reflects the company's anticipated transformation from a clinical stage discovery and development company to a commercial-ready pharmaceutical company. The company's common shares will continue to trade on the Nasdaq Global Market and Cboe Canada under the ticker symbol "HELP".NRX AWARDED DARPA PRIME CONTRACT:NRx Defense Systemsannounced Wednesday the award of ana Branch of the United States Department of War. The underlying clinical trial, the Synaptic Plasticity Augmented Rapid Circuit Stimulation trial has been approved by the U.S. Food and Drug Administration and will now begin enrolling patients. The SPARC-TMS trial will be conducted at Harvard Medical School's McLean Hospital, Arizona State University, and HOPE Therapeutics. Several leading military hospitals will also be affiliated with the study.The focus of SPARC-TMS is to test whether an entire course of transcranial magnetic stimulation delivered in a single day can effectively treat major depressive disorder when combined with mechanism-guided pharmacologic augmentation with NRX-101. TMS is thought to exert its therapeutic effects primarily through synaptic plasticity – the cellular basis of learning and memory. Synaptic plasticity is mediated by NMDA receptors. NRX-101 combines two drugs that may enhance NMDA receptor function through complementary mechanisms: d-cycloserine, an NMDA receptor partial agonist, and lurasidone, which has been shown to increase NMDA receptor expression through 5-HT7 antagonism. The treatment to be tested requires a single day in an outpatient clinic, involves no psychedelic experience or intense supervision, no anesthesia, and can be delivered by a robotic targeting system originally developed for neurosurgery with precision of 1mm or less.OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Bright Minds Biosciences, Compass Pathways, Definium Therapeutics, Eli Lilly, Enveric Biosciences, GH Research, Incannex, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Optimi Health, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Revive Therapeutics, Sibannacand Silo Pharma.