Insights

Read our independent data-driven reporting, analysis and commentary on the psychedelics space: from business and drug development through to policy reform and culture.

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The latest

Unpacking FDA’s MDMA Rejection Letter and the Road Ahead for Lykos

September 8, 2025

Last Thursday, FDA published the complete response letter (CRL) it sent to Lykos Therapeutics last year, when it rejected its MDMA for PTSD new drug application. Here, we take a closer look at the three dealbreaking issues, speak with insiders and observers about its contents, and discuss what it might mean for Lykos’ road to resubmission.

Pα+ Psychedelic Bulletin #208: Psychedelic CEOs’ FDA Wish-List; APA Division 56 President Talks Psychedelics; Compass’ PTSD Study Published; Cybin Ousts Drysdale

September 5, 2025

Psychedelic CEOs’ FDA Wish-List • APA Division 56 President Jessica Punzo on Psychologists and Psychedelics • Compass’ Phase 2 PTSD Study Published • Cybin Ousts CEO Doug Drysdale • DoD to Test Military for Psilocybin • MindMed’s Phase 2b LSD for GAD Study Publishes • and more..

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The Library

Through our years of reporting we have covered many of the topics we believe to be important to the present and future of the psychedelics space, broadly defined. However, much of this commentary is scattered across Bulletins, deep dives, special reports and year-end reviews.

The Library provides digestible explainers on salient topics across psychedelic drug development, policy and business: from basic explainers such as “what is psychedelic-assisted therapy?” through to more complex matters such as REMS programs and bifurcated scheduling.

It’s exclusively available to our Pα+ subscribers, with new content added regularly.

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Pα+ Library: Bifurcated Scheduling

December 6, 2023

Pα+ Library: we introduce some of the key concepts in the matter of bifurcated scheduling; a process by which an approved drug product may be placed in a different schedule to the substance itself. As we discuss in this piece, this could have significant repercussions for psychedelic research, legality, and even taxes.

Pα+ Library: Psychedelic REMS

November 15, 2023

Pα+ Library: we sketch out what a psychedelic REMS might look like, highlighting how these programs could have an outsized impact on the post-approval delivery and accessibility of these treatments.

The Psychedelic News Feed Archives

Archived versions of our Psychedelic News Feed.

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