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August 17 – 23, 2026
August 10 – 16, 2026
This week’s news cycle was led by a readout from Definium Therapeutics, which shared data from the first of two Phase 3 studies in its LSD (DT120) for generalised anxiety disorder program. The trial met its primary endpoint and all key secondaries.
Given the company’s strong readout from a Phase 3 trial of the same candidate in major depressive disorder two months ago, another positive print was expected, and likely priced in. Indeed, shares in the company traded down on the week. We expect Definium to target a new drug application (NDA) submission in H1’27.
Elsewhere in psychedelic drug development, we reported last week that Resilient Pharmaceuticals (formerly Lykos Therapeutics) had resubmitted its new drug application seeking FDA approval of MDMA for PTSD. While we only mentioned the resubmission in passing, it was quickly picked up by MAPS, the MDMA drug developer’s progenitor, who took the opportunity to weigh in.
Resilient remains silent on the matter, with virtually no public-facing presence. This week, we published an article explaining the context surrounding the resubmission and the program that underlies it.
Finally, we published the sixth Issue of The Psychedelic Practitioner on Thursday. As we move toward potential approvals in the coming months, focus now shifts toward preparedness. In this Issue, we explore launch-readiness in the medical model with a focus on people.
Precisely which psychedelic will be the first to receive FDA approval remains an open question, with Resilient’s MDMA resubmission in the queue and two psilocybin developers aiming to file in the coming months.
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelic business, policy, research and beyond.
Josh Hardman
Founder & Editor
August 3 – 9, 2026
A Note From the Editor
Earlier this week, Puerto Rico put itself on the psychedelics-related policy map when Governor González-Colón signed an Executive Order directing the Secretary of its Department of Health to explore ways to catalyse psychedelic research on the island, including via a potential pilot program.
Elsewhere, Montana has launched its experimental drug access pathway that allows biotechs to sell drugs that have cleared Phase I, if they’re accepted by a newly established review board. As with Right to Try, however, many drug developers will be hesitant to operate in such a program.
Indeed, the primary goal of psychedelic drug developers remains FDA approval, an elusive goal that now seems closer than ever for sponsors like Compass Pathways, Usona Institute, and Resilient Pharmaceuticals, whose MDMA new drug application has now been resubmitted to the agency, we understand.
While much of the focus continues to be on launch-readiness in the U.S., a study that published in Nature Medicine earlier this week sets the scene for psilocybin therapy in England’s National Health Service (NHS) setting. That trial, which was positive, was the first publicly funded trial in the UK, too, and used Compass Pathways’ COMP360 psilocybin. Still, launching psychedelic therapies in the UK is a tall ask, as we have seen with other interventional psychiatry treatments like TMS and, perhaps most relevantly, Spravato, which remains unavailable through the NHS.
While it does seem full steam ahead, at least in the U.S., we are also presented with reminders regarding the power of these substances. Another arrived this week, as journalist Kimon de Greef’s new book, ‘The Ego Trip’, published. It charts the history, mythology, and economy surrounding the Sonoran Desert toad and the drug, 5-MeO-DMT, its venom contains. His reporting explores just how dramatic patient and client experiences can be, again raising questions around precisely how psychedelics should, or will, be integrated into our healthcare systems.
Over at Psychedelic Alpha, we’re continuing to look for ways to improve your experience. In response to reader requests, this week we rolled out the option to listen to our Pα+ Psychedelic Bulletins. Audio is generated using artificial intelligence, though the voice model is trained on my own.
We will be rolling out more audio soon, in an effort to help you stay current as we all continue to be busier than ever!
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelic business, policy, research and beyond.
Josh Hardman
Founder & Editor
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