Psychedelic Policy Briefing 8.21.26
In this week’s Psychedelic Policy Briefing, investigative reporter Jack Gorsline dives into three high-impact stories from across the psychedelic landscape. Resilient Pharmaceuticals (formerly Lykos Therapeutics and MAPS PBC), reportedly resubmitted their once-rejected New Drug Application (NDA) for MDMA-assisted therapy for PTSD to the FDA, triggering a fresh review cycle under the agency’s newly finalized psychedelic clinical trial guidance. In other research news, Definium Therapeutics announced that the company’s oral LSD tablet’s top line Phase 3 clinical trial results met the company’s primary and key secondary endpoints. This development raised shares of Definium’s stock by double-digits setting up the company to potentially submit a New Drug Application of their own in 2027. Meanwhile, in Canada, a C$24 million multidisciplinary Canadian Cannabis and Brain Health Consortium officially launched.
MDMA-Assisted Therapy NDA Resubmitted to FDA
As first reported by Psychedelic Alpha on August 9, Resilient Pharmaceuticals has resubmitted its New Drug Application (NDA) for MDMA-assisted therapy for post-traumatic stress disorder (PTSD) to the U.S. Food and Drug Administration (FDA).
The resubmission initiates a new regulatory evaluation following the Complete Response Letter issued by the FDA rejecting the initial application in 2024. Notably, the resubmitted application will not include data from a new phase III clinical trial, which the FDA initially recommended in its CRL. The updated review follows the FDA’s non-binding guidance document, Psychedelic Drugs: Considerations for Clinical Investigations, released in July.
This re-review also follows Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” signed in April by U.S. President Donald Trump, which directs the FDA, HHS, DEA, and VA to accelerate research, regulatory review, and patient access to psychedelic drugs broadly, including the ibogaine Right to Try guidelines and issuance of the Commissioner’s National Priority Vouchers (CNPV).
Canada Launches $24M Cannabis and Brain Health Consortium
On August 12, the Canadian Institutes of Health Research (CIHR) announced a C$24 million federal investment to establish the Canadian Cannabis and Brain Health Consortium.
The consortium unites research teams across Canadian universities and medical centers to study how cannabis affects the brain. Elsewhere in other North American research initiatives, the U.S. National Institutes of Health (NIH) recently convened its biennial BRAIN Initiative Conference in Rockville, Maryland, with a focus on “inventing the future.”
Definium Reports Late-Stage Trial Data for Oral LSD in Generalized Anxiety Disorder
Definium Therapeutics announced top-line results from its Phase 3 clinical trial on August 12, reporting that an oral formulation of LSD significantly reduced symptoms in adults with generalized anxiety disorder (GAD). The study met its primary endpoint, demonstrating a statistically significant reduction in Hamilton Anxiety Rating Scale (HAM-A) scores at 12 weeks compared to placebo.
Unlike early psychedelic protocols that paired drug administration with extensive psychotherapy, Definium designed its trial around a single supervised dose. That design targets commercial adoption within standard psychiatric clinics, sidestepping the therapist credentialing bottlenecks that some industry experts have claimed contributed to the FDA’s rejection of the Lykos’ original MDMA application in 2024.
The new research findings gives the company data to support a New Drug Application to the FDA, which analysts at equity research firm Stifel have said could be filed, ”likely sometime in the first half of next year,” although regulatory clearance is not guaranteed. The broader read-out for the clinical trials is set for September. Meanwhile, federal regulators continue to scrutinize functional unblinding in psychedelic trials, where psychoactive effects make placebo controls difficult to maintain. Definium must also satisfy agency safety standards regarding possible adverse side effects. If approved, the drug would become one of the first classical psychedelics cleared for commercial prescription in the U.S.