Psychedelic Alpha

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

While Q2’s aggregate investment in psychedelics companies was substantially lower than that seen in Q1, it still puts us on track to see around $1bn flow into the space in 2024. We now wait to see how FDA’s decision on Lykos’ MDMA-assisted therapy for PTSD New Drug Application might impact these inflows, with some investors—at least those interested in psychedelic-assisted therapies—holding their breaths in the meantime.

Pα+ Psychedelic Bulletin #169: Sergey Brin Backs Soneira, But Patent Questions Loom Large; J&J Seeks Spravato Monotherapy Approval; Canadian Study to Parse Out Role of Psychotherapy; more.. https://lnkd.in/eNpBnP_r

The 7th Neuropsychiatric Drug Development Summit is returning this September, convening industry leaders to address the most pressing scientific, operational, and regulatory challenges for the development of transformative neuropsychiatric candidates—including psychedelics and psychoplastogens.   While the agenda isn't exclusively psychedelics-focused, there is a strong showing from companies like Lykos Therapeutics, Gilgamesh Pharmaceuticals, Freedom Biosciences, and Compass Pathways; as well as pharma heavy-hitters like Otsuka Pharmaceutical Companies (U.S.), AbbVie, and Biogen. In that sense, the fact that this isn't solely a psychedelics conference is a feature, not a bug, in that it offers an opportunity for psychedelic drug development to be situated within the broader drug development and pharmaceutical fields. You can access the agenda here: https://ter.li/uuhfnu