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Psychedelic: Clearmind completes second cohort enrollment for CMND-100 trial

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on an enrollment completion, a CDMO selection and a listing transfer.

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CLEARMIND COMPLETES SECOND COHORT ENROLLMENT FOR CMND-100 TRIAL: Clearmind Medicine (CMND) announced Tuesday the completion of patient enrollment for the second cohort in its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the company’s proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder. The cohort consists of six patients, who were recruited rapidly across three clinical sites: Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. The enrollment follows the recent completion of the first cohort, which demonstrated encouraging top-line safety and efficacy data, including a favorable safety profile and preliminary signals of reduced cravings and withdrawal symptoms. The multinational Phase I/IIa trial is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. Dosing for the second cohort is expected to commence shortly, with topline results anticipated in the coming months.

“We are thrilled with the accelerated pace of enrollment for our second cohort, which reflects the high level of interest from both patients and leading clinical sites in CMND-100’s potential to transform AUD treatment,” stated Adi Zuloff-Shani, CEO. “Building on the excellent results from the first cohort, we believe that this rapid progress positions us to generate additional valuable data, bringing us closer to delivering a breakthrough therapy that addresses the root causes of addiction with an improved safety profile.”

PHARMALA SELECTS CDMO FOR ALA-002 MANUFACTURING: PharmAla Biotech (MDXXF) announced Monday that its wholly-owned subsidiary, PharmAla Biotech Australia, has contracted with a UK-based CDMO to execute manufacture of its ALA-002 drug substance. ALA-002 is PharmAla’s patented, novel, non-racemic MDMA formulation. PharmAla has publicly announced that it will be initiating Phase 2a/2b clinical research into the formulation exploring Social Anxiety Disorder in 2026.

“PharmAla Australia worked diligently, executing a global RFP search to find our ideal partner for process development and manufacturing of the ALA-002 drug product components,” said Nick Kadysh, CEO. “This is an important and necessary step to us executing our ALA-002 Phase 2 clinical trial in 2026, and the first time since 2022 that PharmAla will be developing a wholly new Active Pharmaceutical Ingredient for human use.”

Additionally, PharmAla announced that it has completed one of two contracted shipments of LaNeo MDMA to the Parsons Research Center for Psychedelic Healing at Mount Sinai. The material is scheduled to be used in clinical research.

CYBIN TO TRANSFER LISTING TO NASDAQ: Cybin (CYBN) announced Thursday that it will voluntarily transfer its U.S. stock exchange listing to the Nasdaq Global Market from the NYSE American. The company expects that its common shares will cease trading on the NYSE American at market close on January 4, 2026 and commence trading on Nasdaq at market open on January 5, 2026. Concurrent with the commencement of trading on Nasdaq, the company will no longer trade under the ticker symbol “CYBN” and instead will trade under the ticker symbol “HELP”. The company will continue to be listed on the Cboe Canada and will also trade under the new “HELP” ticker symbol commencing on January 5, 2026.

“We are pleased to join the community of global pharmaceutical companies listed on Nasdaq and thank the NYSE American for supporting the company over the last four years since our initial listing,” said Eric So, interim CEO. “The transfer to Nasdaq marks the next step in the evolution of Cybin into a global pharmaceutical company.”

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), NRx Pharmaceuticals (NRXP), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF) and Silo Pharma (SILO).

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