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Clearmind Medicine Inc. (NASDAQ:CMND), (FSE: CWY0) ("Clearmind" or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced the initiation of its FDA-approved Phase I/IIa clinical trial for CMND-100 at Hadassah Medical Center in Jerusalem, Israel. This milestone expands the trial to another leading global medical center, emphasizing the potential and growing momentum behind CMND-100—a proprietary non-hallucinogenic MEAI-based oral drug candidate designed to address the unmet needs of millions suffering from Alcohol Use Disorder (AUD).
The multinational, multi-center study evaluates the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of CMND-100 in reducing alcohol cravings and consumption among individuals with moderate to severe AUD. Following final approval received earlier this month, Hadassah—a leading Israeli institution, has swiftly activated the site. The activation follows the company's previous announcement in June 2025 that Hadassah Medical Center was being added as an additional clinical site for its ongoing Phase I/IIa clinical trial.
The company recently announced top-line data from the first cohort of the clinical trial that demonstrated a favorable safety profile, with no serious adverse events reported and the treatment was generally well-tolerated across all participants. Additionally, the cohort showed strong treatment observance, with high adherence to the dosing regimen and protocol requirements, underscoring the feasibility and patient acceptability of CMND-100 in a clinical setting. These encouraging early findings support the ongoing evaluation of CMND-100 as a potential breakthrough therapy for AUD, a condition affecting millions worldwide where effective treatments remain limited.
Posted In: CMND