Psychedelic: Clearmind reports CMND-100 dosing at Hadassah Medical Center

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on dosing, FDA filings and an analyst note.

CLEARMIND REPORTS CMND-100 DOSING AT HADASSAH MEDICAL CENTER: Clearmind Medicine (CMND) announced Tuesday another milestone in its Phase I/IIa clinical trial for the treatment of Alcohol Use Disorder, the first participant has been enrolled and dosed with CMND-100, its proprietary MEAI-based oral drug candidate, at Hadassah-University Medical Center in Jerusalem, Israel. The trial at Hadassah-University Medical Center is led by Prof. Joseph Caraco, Director of the Clinical Pharmacology Unit in the Department of Medicine. This site is part of the company’s multinationalclinical trial evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of CMND-100 in patients with AUD. Recent top-line results from the first cohort and unanimous Data and Safety Monitoring Board recommendation that the clinical trial continue contribute to supporting strong momentum across all active sites.

“We believe that dosing the first participant with CMND-100 at Hadassah Medical Center marks yet another significant step forward in expanding our global trial footprint and accelerating our path to potentially delivering innovative treatments for AUD,” said Adi Zuloff-Shani, CEO. “Hadassah’s expertise in clinical research, combined with our encouraging early data from the first cohort, brings us closer to potentially transforming the lives of millions affected by alcohol use disorder.”

NRX REPORTS FDA RECEIPT OF KETAFREE ANDA: NRx Pharmaceuticals (NRXP) announced Tuesday that the U.S. Food and Drug Administration has received the company’s Abbreviated New Drug Application for KETAFREE, a preservative-free intravenous ketamine formulation. The acknowledgement letter states that the FDA has “made a threshold determination that this ANDA is substantially complete” and issued a goal date of July 29, 2026 for completion of the final review with potential marketing approval.

“We appreciate FDA’s careful review and are pleased that it has received our application for KETAFREE, an important milestone in our effort to bring a single-patient, preservative-free presentation of ketamine to the patients and clinicians who depend on this medicine,” said Jonathan Javitt, CEO. “Current ketamine products are typically supplied in multi-dose vials that contain a preservative called Benzethonium Chloride that is not recognized as safe by FDA and banned from hand cleansers and topical antiseptics.”

Additionally on Wednesday, NRx announced that it has amended its Investigational New Drug filing for NRX-101 to include the use of NRX-101 in association with Transcranial Magnetic Stimulation for the treatment of depression, including suicidal depression. In the third quarter, the company identified a new indication for NRX-101 that potentially offers a rapid path to commercialization for this drug. Recent evidence suggests that NRX-101 may confer a significant added advantage to the clinical results of Transcranial Magnetic Stimulation. Cole and colleagues reported that patients randomized to D-cycloserine vs. Placebo concurrent with TMS using a standard protocol experienced a greater than two-fold benefit in terms of reduction in symptoms of depression. Clinical response of 75% and remission of 40% was seen in the DCS-treated group. A substantial body of nonclinical literature has been published in subsequent years demonstrating that DCS at low doses exerts a neuroplasticity effect and causes dendritic sprouting in areas of the brain associated with depression.

On November 4, Real World Data were presented in conjunction with use of a modern Theta Burst FDA-cleared TMS device and a one day TMS protocol, combined with a single administration of oral DCS. The authors reported 87% clinical response and 72% remission manifesting at 6 weeks after a single day of treatment on the Hamilton Depression Rating Scale with similar findings on other standard test measures. NRx believes that the clinical benefit demonstrated in these two published trials can be demonstrated in a well-controlled trials of approximately 120 participants. The company is in partnership discussion with manufacturers of currently-marketed TMS devices to configure a joint clinical trial that will lead to drug registration and augmentation of FDA labeling of currently-approved TMS devices.

CYBIN PRICE TARGET RAISE: Guggenheim raised the firm’s price target on Cybin (CYBN) to $48 from $39 and kept a Buy rating on the shares. Noting that the company’s Phase 3 program for CYB003 in adjunctive MDD is advancing as planned, the firm said it expects Cybin to have “a strong 2026 performance.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Health (AGNPF), Atai Beckley (ATAI), BetterLife (BETRF), Bright Minds (DRUG), Compass Pathways (CMPS), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF) and Silo Pharma (SILO).