Psychedelic Alpha

Pα+ Psychedelic Bulletin 178: VA Funding of Lykos Phase 3 ‘Definitely a Possibility’; Alto’s Precision Psychiatry Platform Under Pressure; MAPS Boosts Funding for Mass. Psychedelics Ballot Question https://lnkd.in/esTSDcQK

Natural Medicine Advisory Bulletin 14: Vicente LLP looks at big-picture questions as the program hurtles towards launch. First up are fees and rule changes, before the firm reviews Natural Medicine-related meetings since our last Bulletin in late August. https://lnkd.in/eTXjf9FR

Psychedelics Take Centre Stage in Massachusetts’ Local Media: Q4 Pros and Foes square off in ballot question debate series. https://lnkd.in/eznNeaPE

Next month, Massachusetts will vote on Question 4, which would establish a regulated psychedelics program in the state. Right now, it's too close to call with polls showing opinions are within the margin of error. What do you think will be the outcome?

Exclusive: David Hough on Lykos’ Path to Resubmission In this exclusive interview, our Editor Josh Hardman sat down with Hough to discuss how his experience in developing Spravato to eventual approval 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. https://lnkd.in/gSJEz6GU

Lykos Therapeutics CEO Amy Emerson wrote to FDA Commissioner Robert Califf to provide comments on the Advisory Committee process, including the company's own ill-fated AdComm.

Breaking: Following FDA Rejection, Lykos Therapeutics Lays Off 75% of Staff, Ropes In Pharma Veteran, Doblin Resigns Board https://lnkd.in/eTWKT2FA

Psychedelic Bulletin 170: - MindMed Tops Up Healthy Cash Balance with $75M Raise; Eyes Adding Depression to Pipeline? - atai Life Sciences Approaches Phase 2 for DMT and R-MDMA Candidates - Compass Pathways’ Phase 3 Program Generally On-Track, Potential for Slight Delay on Readout - European Psychiatrists Remain Open to Psychedelics, Research - and more... https://lnkd.in/ggbnbUfN

Lykos Plots FDA Appeal: Reeling from CRL and Journal Article Retractions, MDMA Developer Hopes to Change Your Mind Josh delves into FDA’s appeal process with regard to Lykos Therapeutics’ development program, and covers the trio of journal article retractions that have cast another shadow over the company’s published studies. Plus: We assess the fallout beyond Lykos, as psychedelic drug developers wrestle over the role of psychotherapy in their protocols, fast followers assess their strategies, and would-be psychedelic therapy delivery companies face a substantial delay. https://lnkd.in/eFn2RuSm

BREAKING: FDA Rejects Lykos Therapeutics’ MDMA-Assisted Therapy For PTSD The agency requests an additional Phase 3 study, which would add several years to the timeline and require a substantial cash injection. https://lnkd.in/eQ_PszYC