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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.
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..
FDA has published its complete response letter (CRL) to Lykos Therapeutics, citing durability, safety, and bias concerns in rejecting MDMA therapy for PTSD. Here, we very briefly unpack the letter.
The FDA is pushing researchers to reduce their use of animal models and instead adopt ‘new approach methodologies’, like organoids and AI modelling. Here, Dr. Alaina Jaster speaks with psychedelic scientists and drug developers to unpack the debate.
Lykos Therapeutics Rebrands to Resilient Pharmaceuticals • Pharma Pushes Back on Norway’s Off-Label Ketamine Decision • AbbVie–Gilgamesh Deal Viewed as Validation for Short-Acting Psychedelics • Psilocybin Rescheduling Petition Heads to HHS • Sensorium Scores $25M Series A Extension to Take Kanna-Based Candidate Into Clinic • Researchers Call Lykos’ MDMA Pricing Modelling “Problematic” • Alabama Board of Medicine Issues Guidelines for Off-Label Ketamine in TRD • FDA Approves PharmaTher’s Ketamine After Two CRLs • Incannex Reports Positive Phase 2 Results for Psilocybin-Assisted Psychotherapy in GAD • and more..
AbbVie is set to buy Gilgamesh Pharmaceuticals’ lead candidate, GM-2505 (bretisilocin), in a deal worth up to $1.2bn. Here, we take a closer look at the acquisition, what it might tell us about big pharma’s interest in the field, and what it might mean for the broader crop of psychedelic drug developers…
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.
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: 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.
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