Psilocybin

FDA rejected Lykos Therapeutics' NDA for MDMA therapy for PTSD, citing insufficient evidence of efficacy and safety. Advisory Committee voted 9-2 against effectiveness and 10-1 against benefits outweighing risks. Concerns included 'functional unblinding' and psychotherapy regulation. Lykos plans to meet FDA for next steps.

FDA meeting on PTSD treatments reignited debate over delayed approval of Lykos Therapeutics' MDMA-assisted therapy. Critics, including Dr. Robert M. Grant, argue FDA's review failed, citing inconsistent guidance and unmet needs for better PTSD treatments. Despite FDA's cautious approach, veterans and researchers advocate for urgent action, highlighting the growing disconnect between FDA's stance and the insistent needs of potential beneficiaries. MAPS plans to continue Phase 3 trials and educate healthcare providers and policymakers, aiming to provide access to treatments regardless of FDA requirements.

FDA found psychoactive substances in Diamond Shruumz products, causing 158 illnesses, 63 hospitalizations, and 2 deaths. Recalled products include Dark Chocolate Bar and Birthday Cake Chocolate Bar, containing 4-acetoxy-DMT, desmethoxyyangonin, dihydrokavain, and kavain. FDA advises avoiding all Diamond Shruumz products.

Incannex Healthcare Inc. secured a $60 million financing agreement with Arena Investors, LP, including $10 million in convertible notes and a $50 million equity line of credit, to advance clinical-stage drug candidates. The funds will support ongoing clinical trials and general corporate purposes.

Mindstate Design Labs gains FDA and EMA approval for human trials of MSD-001, a neurotech AI-designed compound targeting specific serotonin receptors. The Phase 1 trials, to be held in Leiden, will assess safety and neural impacts using advanced techniques. Mindstate's Osmanthus platform integrates AI with 70,000 drug reports and biochemical data to design precise psychoactive effects.

Researchers believe psychedelics could treat mental health, with ongoing trials in UK and worldwide. Psilocybin shows most evidence for effectiveness, with potential benefits beyond serious conditions. Despite tight UK control, businesses invest in psychedelic treatments, anticipating global authorization.

Psilera's PSIL-006, a non-psychedelic psilocybin-based drug, shows promise in treating frontotemporal dementia (FTD) with a strong safety profile in preclinical studies, potentially paving the way for FDA approval and addressing a critical need in dementia care.

Psyence Biomedical completes first site initiation visit for Phase IIb study of nature-derived psilocybin for Adjustment Disorder in Palliative Care, with patient screening to start soon and first subject expected in October.

Psyence Biomedical Ltd. completed the first site initiation visit for its Phase IIb study of nature-derived psilocybin as a potential treatment for Adjustment Disorder in Palliative Care. The study, supported by partnerships with Fluence and iNGENū CRO, will evaluate two therapeutic doses of psilocybin (10mg, 25mg) against a low-dose comparator (1mg) in 87 patients. Patient screening will commence soon, with the first subject expected to be randomized in October. Topline data is anticipated in the second half of 2025, potentially leading to a Phase III clinical program.