Live Coverage Announcement: We will be covering next Tuesday’s Advisory Committee meeting live on Psychedelic Alpha. Join our newsletter to receive the link on the day. *** In less than a week, an FDA advisory committee will meet to discuss Lykos Therapeutics’ MDMA-assisted therapy for PTSD (see What to Expect: FDA Advisory Committee Set to Review MDMA-Assisted Therapy for PTSD). Last month… Source ..read more

Next week, the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) will meet to discuss Lykos Therapeutics’ MDMA-assisted therapy for PTSD New Drug Application (NDA). While PDAC’s determination on whether the therapy should be approved is non-binding, the meeting—which is scheduled to run between 8:30 AM and 4:30 PM EST on June 4th—provides an opportunity for a first look at how the FDA… Source ..read more

We added 16 PCTs and 26 U.S. patent applications focused on psychedelics to our tracker in the month of April 2024. New entries came from the likes of Psilera, Aya Biosciences, Algernon, ASRI, Terran, GH Research, and more. (Subscribe or sign-in, below, to explore the interactive tables.) *** In early April, a shared PCT (WO2024073356) from psychedelic drug developers the… Source ..read more

Featured content in this Issue: *** Already this month we have seen two financing or dealmaking events among psychedelics companies that have rallied investors and company execs alike. In the first week of May, a weary Reunion Neuroscience surprised many by announcing a $103M Series A round to progress its 4-HO-DiPT prodrug candidate through a suite of Phase 2 studies (see Reunion… Source ..read more

California Senate Bill 1012, The Regulated Psychedelic Facilitators Act and the Regulated Psychedelic-Assisted Therapy Act, has died after the Senate Appropriations Committee held it on file as part of the ‘suspense day’ culling process.The bill would have established regulated, licensed psychedelic services in the state, replete with a Board of Regulated Psychedelic Facilitators and a Division of… Source ..read more

Last Friday, the Under Secretary for Health at the Department of Veterans Affairs (VA), Shereef Elnahal, spoke on stage at Horizons’ 16th conference in New York City alongside Healing Breakthrough’s Executive Director Jason Pyle.“The reason I’m here,” Elnahal said, “is that the data and results, the stories that I have heard from veterans who have gone through these studies, these therapies… Source ..read more

In late March, the Institute for Clinical and Economic Review (ICER) published its draft evidence report on MDMA-assisted psychotherapy (which it abbreviates to ‘MDMA-AP’) for the treatment of PTSD. For more background on ICER and the original draft evidence report, please see our contemporary coverage: ICER Draft Evidence Report on Lykos’ MDMA-Assisted Psychotherapy Deems Clinical Evidence… Source ..read more

AbbVie has become the latest large pharmaceutical company to dip its toes into neuroplastogen research and development as it announced what might be the most substantial foray of its kind this morning. (Editor’s note: An earlier version of this article read: “AbbVie has become the latest large pharmaceutical company to dip its toes into psychedelic drug development”. A representative from AbbVie… Source ..read more

Save the date: the FDA will hold an advisory committee meeting to review Lykos Therapeutics’ New Drug Application (NDA) for MDMA-assisted psychotherapy in the treatment of PTSD on June 4th, 2024. The purpose of FDA advisory committees is to provide “independent, expert advice” to the agency [1]. In this case, it will be the agency’s Psychopharmacologic Drugs Advisory Committee (PDAC) that is… Source ..read more

Save the date: the FDA will hold an advisory committee meeting to review Lykos Therapeutics’ New Drug Application (NDA) for MDMA-assisted psychotherapy in the treatment of PTSD on June 4th, 2024. The purpose of FDA advisory committees is to provide “independent, expert advice” to the agency [1]. In this case, it will be the agency’s Psychopharmacologic Drugs Advisory Committee (PDAC) that is… Source ..read more