COMPASS Pathways

Cybin Inc. and MindMed Inc. plan to start phase 3 trials for psilocybin and LSD treatments in 2023, aiming for 2026 results. Despite recent setbacks, including FDA rejections and data issues, both companies remain optimistic, supported by FDA approvals and cautious analyst optimism.

Innovation in neuropsychiatry is reviving after 40 years of dormancy, with recent approvals like Bristol Myers Squibb’s Cobenfy and Sage Therapeutics’ Zurzuave. Large Phase III studies on psychedelics aim to shift from anecdotal to evidence-based treatments. Challenges include high costs of Phase III trials and lack of effective animal models for CNS disorders. Investment in neuroscience is cyclical, with a need for better patient selection and biomarkers. Infrastructure and less intrusive diagnosis methods, like blood-based biomarkers, are crucial for tackling neurodegenerative diseases. AI and analytics advancements could improve diagnostic efficiency and patient targeting, despite regulatory hurdles and mixed public perception in neuropsychiatry.

Compass Pathways (CMPS) cuts 30% of workforce, including senior management, due to Phase 3 trial delays, halting non-COMP360 preclinical efforts and exploring externalization for digital health tools.

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.

Madrigal's Rezdiffra sales exceed expectations, Compass Pathways lays off 30% of staff due to delayed clinical trials, UCB's tau-targeting Alzheimer's drug bepranemab shows mixed results, and Lilly's earnings surprise discussed on 'The Readout LOUD' podcast.

Shortwave Life Sciences Plc announces its annual results for the year ended 30 April 2024, highlighting the acquisition of Shortwave Pharma Inc. and the growth of its PSYCH platform. The company also reports a strategic rebranding and significant milestones in drug development, including positive pre-clinical safety results for a psilocybin-based drug. Financial results show a decrease in revenues and an operating loss, with a focus on future fundraisings to support ongoing operations.

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.

Semaglutide shows promise in treating osteoarthritis, potentially paving the way for FDA approval. Ozempic and Wegovy, both semaglutide-based drugs, are now listed as available by the FDA, potentially impacting compounding pharmacies. CRISPR gene editing continues to advance with notable researchers like Alexis Komor and Patrick Hsu. AstraZeneca's top executive in China is under investigation. A small study indicates TMS may slow Alzheimer's progression.

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.