Psychedelic Alpha

Pα+ is the insider’s guide to the business, policy and science of psychedelics. Independent data-driven reporting, analysis and commentary on the psychedelics space: from business and drug development through to policy reform and culture. psychedelicalpha.com/join

Field Notes #3: Washington’s Busy Week, and the Biggest Psychedelic Buyout Yet In this Field Note, Josh discusses the busiest week in the psychedelics-as-therapeutics field to date, including: • FDA’s final guidance for industry on clinical investigations of psychedelics • A public meeting scheduled for September, hosted by FDA, that will examine the potential rollout of psychedelic therapies • A NIDA grant awarded to researchers at Harvard to study ibogaine • Eli Lilly’s planned acquisition of AtaiBeckley Listen now on our website: psychedelicalpha.com/news/field-not…

“Once it’s submitted, it obviously gives the FDA an opportunity to respond to what we have, and that’s going to give us a clearer picture of what’s required”, Suzuki explained. “Best case scenario they approve it right away,” he went on, “worst case scenario they put it on hold and request additional preclinical testing.” - Joji Suzuki Read the full conversation on our website: psychedelicalpha.com/news/backed-by…

Following a series of announcements earlier this week, the U.S. Food and Drug Administration (FDA) homepage now features the agency's work in "Advancing Research on Psychedelic Drugs'.

“Common group-level ruptures often emerge when someone feels unseen or left out (e.g., when one person gets more attention or support than others, when someone’s intense experience overwhelms the room, or when a participant who had a difficult or underwhelming session feels out of step with a group that’s focused on breakthroughs). Ruptures also happen when facilitators or other participants interpret someone’s experience too quickly, before that person has had a chance to make sense of it themselves.” Dr. Gabby Agin-Liebes spoke with us for the Fifth Issue of The Psychedelic Practitioner, which focuses on psychedelic groups in practice. Read now on our website: psychedelicalpha.com/news/the-psych…

World’s Largest Pharmaceutical Company, Eli Lilly, Acquires 5-MeO-DMT Developer AtaiBeckley for Up to $3.8 billion Read more on our website: psychedelicalpha.com/news/breaking-…

Last week, we wrote that a substantial deal involving psychedelic drug developer AtaiBeckley was nearing completion. This evening, Bloomberg reported that Eli Lilly, the world’s largest pharmaceutical company, isn in talks to acquire the company. News could come as soon as this week, Bloomberg states.

Eli Lilly nears deal to buy psychedelic drugmaker AtaiBeckley, Bloomberg News reports reuters.com/business/healt…

MAPS Publishes Ibogaine Investigator’s Brochure The nonprofit MAPS has published an investigator’s brochure (IB) for ibogaine in a “free, open-access” manner. The 207-page document compiles available data on the drug into a single resource, lead authored by Brock Pluimer. Read more on our website: psychedelicalpha.com/news/p%ce%b1-p…

Will Branded MDMA Go By ‘Rysanso’? Is RYSANSO the brand name that Resilient Pharmaceuticals is targeting for its MDMA (midomafetamine) for PTSD product, should it score approval?  FDA’s presentation before the Psychopharmacologic Drugs Advisory Committee just over two years ago seems to have accidentally let a reference to the potential brand name slip through at the bottom of a slide, where a footnote reads: “Lykos Therapeutics. Proposed Prescribing Information for Rysanso, March 14, 2024.” We had first reported on the potential brand name in 2023, when we came across a trademark filing by MAPS PBC (which later became Lykos, then Resilient). More recently, we discovered that the ownership of the trademark application has transferred to Resilient. We have also deduced that Johnson & Johnson appears to be advertising against the keyword on Google. When searching for the term in the U.S., sponsored results encourage users to navigate to “Discover a TRD Option”, linking them to the Spravato website. Read more on our website: psychedelicalpha.com/news/p%ce%b1-p…

Following Sale to Otsuka, Transcend Launches $20 Million Philanthropic Field-Building Initiative This morning, the Transcend Public Benefit Corporation launched a $20 million philanthropic initiative, following the sale of methylone drug developer Transcend Therapeutics to Otsuka in a transaction valued at up to $1.225 billion. It says it will direct the funds to nonprofit organisations “advancing mental health treatment access, field infrastructure, and research in the psychedelic therapeutics.” It intends to disburse the $20M over the next year. Funding priorities mentioned by Transcend include “support for survivors of sexual trauma, substance use and addiction, end of life care, depression, LGBTQ+, and other underserved populations whose needs have outpaced the field's current infrastructure.”

Our Psychedelic Drug Development Tracker was featured in the Wall Street Journal’s video feature on 5-MeO-DMT yesterday. Explore the tracker: psychedelicalpha.com/resources/psyc…

Backed by $11M NIDA Grant, Harvard Moves Forward on Ibogaine for Opioid Use Disorder Research Read more on our website: psychedelicalpha.com/news/backed-by…

“Most people who take psychedelics already do so in collective settings where attention is given to group harmony—whether in rituals, ceremonies, or even raves. So organically, group processes are already happening, and they’re actually more common than individual ones.” Dr. Leor Roseman spoke with us for the Fifth Issue of The Psychedelic Practitioner, which focuses on psychedelic groups in practice. Read now on our website: psychedelicalpha.com/news/the-psych…

Today has brought a flurry of federal announcements regarding psychedelics, with the FDA (Food and Drug Administration), VA (Department of Veterans Affairs), ARPA-H (Advanced Research Projects Agency for Health), NIDA (National Institute on Drug Abuse), and HRSA (Health Resources and Services Administration) all going on the record in support of psychedelics-related efforts. In our latest, we provide a brief recap: psychedelicalpha.com/news/keeping-u…

The U.S. Department of Health and Human Services and the Department of Veterans Affairs today announced that they have entered into a memorandum of understanding to collaborate on the research, development, and "responsible deployment" of psychedelic drug products to veterans, if FDA-approved. Today's news comes three months after President Trump signed a psychedelics-focused executive order, which called for greater collaboration between the two entities. Read more: hhs.gov/press-room/hhs…

On September 14th, FDA will host a public hearing at its White Oak Campus in Maryland to explore 'considerations for potential future therapeutic use of psychedelics'. Announced today alongside a request for comments, the agency says the meeting aims to "obtain feedback and perspectives on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance in supervised and supportive settings." Registration and requests to present oral comment, both virtual and in-person, can be made via the agency's website. Learn more via our reporting, live now on our website.

FDA Issues Final Psychedelics Guidance, Schedules September Hearing on the Future of Psychedelic Therapies Here, we share our section-by-section comparison with the 2023 draft guidance, a review against stakeholder feedback, and a look at September’s psychedelics public hearing. Read more on our website: psychedelicalpha.com/news/fda-issue…

Delaware Judge Dismisses Signant’s Suit Against Definium A suit brought against Definium Therapeutics by Signant Health was dismissed by a Delaware judge late last month. In his decision (PDF), U.S. District Judge Gregory B. Williams granted Definium’s motion to dismiss the complaint on the basis that Signant “fails to identify its trade secrets with sufficient particularity and only identifies broad categories of information”. Read more on our website: psychedelicalpha.com/news/p%ce%b1-p…

British Researchers Score £2.5M Wellcome Funding A group of researchers in the UK have secured a £2.5M ($3.35M) Discovery Award from the Wellcome Trust for PATHS: Psychedelics as Therapeutics: Harm Reduction and Safety. The five-year project seeks to explore “what happens to the millions of people who are already using psychedelics therapeutically, outside of any clinical trial or formal medical setting?”, among other questions. Read more on our website: psychedelicalpha.com/news/p%ce%b1-p…

“The group isn’t just a cheaper container; it can offer conditions individual work can’t. There’s the potential for mutual care, peer support, and shared accountability—every person in the room can become a source of attunement and witnessing. And unlike facilitators or therapists, who are typically bound by their role to step back once the work is done, peers can continue to hold one another well beyond the intervention itself.” Max Crosland-Wood spoke with us for the Fifth Issue of The Psychedelic Practitioner, which focuses on psychedelic groups in practice. Read now on our website: psychedelicalpha.com/news/the-psych…