Explore our 🎯 Q1 2026 Psychedelic Pipeline Bullseye Charts.
Earlier this week, Psychedelic Industry UK (PsyIndUK) announced its launch. The new association says that it aims to represent the country’s ‘psychedelic medicine and wellness sector’, with founding members including Heroic Hearts Project UK, Onaya, and Imperial College London’s Centre for Psychedelic Research.
Robin Carhart-Harris; Christian Angermayer; Ekaterina Malievskaia and George Goldsmith; Srinivas Rao; Rick Doblin; Matthew Baggott; David Nutt; Robert Barrow; Doug Drysdale; Michael Mullette.
A final decision on fees for healing centres, cultivators, and manufacturers has been pushed back, but Colorado remains on track to begin accepting license applications at year-end. A public hearing will take place on October 21st at 1-3:30pm Mountain Time via Zoom.
While Janssen’s Spravato is on-track to become a blockbuster drug, access to the esketamine nasal spray product continues to be a key Acchiles heel for patients and their providers. Here, through study of two recent publications and interviews with their authors, we look at variability in access to, and real-world usage of, the therapy that psychedelic drug developers are increasingly hoping to imitate.
Cochrane Library publishes its first systematic review of psychedelic-assisted therapy, which focuses on its uses in mental health challenges among people with life-threatening diseases. Read the plain English summary here.
A small nonprofit clinic in Waynesville, North Carolina has been part of a national movement to broaden the use of MDMA to treat post-traumatic stress disorder.
Exclusive: David Hough on Lykos’ Path to Resubmission
Josh sits down with the man drafted in by Lykos Therapeutics to plot a path to resubmitting its MDMA application. They talk about Hough’s experience in developing Spravato to eventual approval and how that might inform any future clinical development of MDMA, Hough’s thoughts about the FDA’s verdict and the AdComm that preceded it, what a future Phase 3 program might look like, and more…
“Drug Science and UCL are undertaking novel research using a bold alternative approach to understanding how MDMA works. The researchers aim to begin recruiting study participants in 2025.”
Our Editor, Josh Hardman, spoke to Labiotech about how Lykos’ FDA rejection impacts the broader field of psychedelic drug developers.
WaPo covers Mindstate Design Labs’ news that FDA and EMA have green-lit a Netherlands-based Phase I study of its 5-MeO-MiPT-based candidate.
Psyence scoops up fellow psilocybin drug developer for just $500k upfront (paid in shares, no less). Clairvoyant, which is currently trialling a psilocybin-based candidate for alcohol use disorder in a Phase 2 study, also has the chance to earn two $250k milestones as part of the deal… but this is still a punishingly low valuation for a company that raised $3M in the heady days of 2021.
Around $10M in funding is available via the Defense Medical Research and Development Program (DMRDP). Application intent deadline is 20th September.
Just four weeks remain until the 7th Neuropsychiatric Drug Development Summit addresses industry’s most pressing scientific, operational, and regulatory challenges for the development of transformative neuropsychiatric candidates. Amidst the recent stall in MDMA progress, the meeting’s timely return will unite leaders from Lykos, Compass, Otsuka, MindMed, Cybin, Gilgamesh and more to share lessons learned, assess progress, and confront the inevitable challenges faced by a new era of psychedelic drug development.
September 24-26, 2024, Boston, MA
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