Psilocybin

A study in AJOB Neuroscience finds 89% of Americans support supervised psilocybin use for mental health treatment, and 85% for well-being enhancement, highlighting bipartisan approval. Support varies slightly with age and political leanings, with care and empathy values influencing positive views. The study cautions against hype, emphasizing the need for rigorous research and accurate claims to guide future policy.

COMPASS Pathways (CMPS) delays pivotal trial data for COMP360 due to recruitment challenges, now expected in Q2 2025 for COMP005 and H2 2026 for COMP006. The company focuses on COMP360's potential in treatment-resistant depression (TRD) and adjusts operations to preserve cash, including a 30% workforce reduction. COMPASS prepares for COMP360's launch, ensuring delivery centers are ready and enhancing TRD awareness. Despite challenges, the company remains confident in COMP360's development and commercial viability.

Compass Pathways delays Phase III readouts for its psilocybin therapy for treatment-resistant depression to 2025 and 2026, resulting in a 30% workforce reduction. The decision, influenced by increased regulatory scrutiny on functional unblinding and logistical complexities, aims to protect trial integrity. COMP360 has shown promise in earlier studies, with significant depressive symptom reduction lasting up to 12 weeks.

Compass Pathways to cut 30% of workforce, halt early-stage research, and focus on COMP360 Phase 3 trials; net loss widens to $38.5M; top-line data expected Q2 2025; COMP006 results delayed to H2 2026 due to increased regulatory scrutiny; restructuring follows RBC Capital Markets' 'Outperform' rating; co-founder George Goldsmith sells shares to former co-founder Lars Wilde; faces competition from Cybin Inc. and Usona Institute; R&D costs rise to $32.9M; cash reserves expected to fund operations into 2026.

The FDA's delay in approving MDMA-assisted therapy for PTSD highlights ongoing challenges in psychedelic medicine, but experts at HLTH 2024 suggest continued research and state initiatives may address FDA concerns, aiming for broader availability and insurance coverage.

On September 6, 2024, the Reagan-Udall Foundation for the FDA held a public meeting on advancing PTSD treatments, including psychedelics. Representatives from the FDA, SAMHSA, DoD, and VA discussed their initiatives, emphasizing the unmet need for effective PTSD treatments. The meeting followed the FDA's denial of Lykos Therapeutics' NDA for MDMA-AT, sparking public disappointment. The meeting highlighted federal efforts to advance PTSD research and treatment, including psychedelic research, and the urgent need for more effective mental health treatments.

Psilocybin, the active ingredient in 'magic mushrooms,' is compared to the antidepressant escitalopram in a six-month trial for depression. Psilocybin showed greater flexibility in brain states and higher well-being scores, but both treatments had comparable depressive symptom improvements. Critics argue for more extensive trials and addressing issues like cost and patient selection before widespread use.

Psyence Group's associate, Psyence Biomedical, recruits Empax Center in Australia for Phase IIb trial on psilocybin-based treatments for Adjustment Disorder in palliative care. First patient expected in early December, with topline data anticipated by second half of 2025.

Psyence Biomed recruits Perth's Empax Center for its Phase IIb trial of nature-derived psilocybin for Adjustment Disorder in Palliative Care, aiming for topline data in H2 2025.

Lykos may use third-party review for Phase 3 data; VA funding possible. Precision Psychiatry Platform faces pressure as Alto's ALTO-100 fails in MDD trial. Antidepressant withdrawal doesn't affect psilocybin efficacy, Compass study shows. Massachusetts: MAPS funds Yes on Question 4. Czech Republic creates low-risk psychoactive substance category. Other stories include Eli Lilly's Alzheimer's drug blocked by NICE, SXSW's 2025 psychedelics lineup, Imperial's UK psilocybin study funding, Seaport Therapeutics' $225M Series B, and FDA's complete response letter to PharmaTher.