July 13 – 19, 2026

FDA Issues Final Psychedelics Guidance, Schedules September Hearing on the Future of Psychedelic Therapies

Psychedelic Alpha ↗

13 July 2026

July 6 – 12, 2026

A Note From the Editor

It’s been a very busy week in the psychedelics field, both in the pursuit of FDA approval and beyond.

On Wednesday, Massachusetts House legislators passed language buried in the state’s $561M economic development bill that would permit up to three licensed mental health clinics to offer ‘naturally occurring’ psilocybin as part of a 5-year pilot program.

While the bill still requires sign-off by the Senate and Governor Maura Healey, advocates view that as a formality rather than a substantial hurdle. The bill does not carve out funding for the pilot, but a prominent advocate and philanthropist in Massachusetts tells me that this is a top priority.

Over in the drug development world, Compass Pathways announced 6-month data from its second, larger Phase 3 trial of COMP360 psilocybin in treatment-resistant depression on Tuesday. The fresh data constitute the latest in a string of positive (though not splashy) readouts from the company, which should be sufficient for approval.

Compass expects to submit its final new drug application (NDA) to FDA in the fourth quarter of the year, with a potential launch in the first half of 2027. Shares in the company traded flat on the week.

Other psychedelic drug developers are also looking to file NDAs in the coming months, as we have reported previously. Those include Usona Institute, which is also developing a psilocybin candidate, and Resilient Pharmaceuticals, the MDMA developer formerly known as Lykos Therapeutics.

Resilient’s NDA filing is imminent, we understand, though it is unclear whether the company will announce the milestone. It is also unclear how swiftly the agency will review the proposed product, which we have predicted will go by the brand name Rysanso. While resubmissions can be reviewed more quickly than a new submission, the program does not benefit from a Commissioner’s National Priority Voucher and its 2024 rejection was surrounded by controversy.

Regardless, all this activity continues to underwrite our expectation that we will see multiple FDA approvals of psychedelic products in the next few quarters. With that, much of the work should turn to access; chiefly, establishing and refining payment and care delivery models.

That is why I am thrilled to share that Psychedelic Alpha is co-hosting The Psychedelic Business Forum at Horizons conference in New York City on October 15th. Explore the agenda and use code PA-FOURTH for a discount on registration before the end of Monday. I do hope you’ll join us.

Next week is going to be very busy from the outset, so I hope you enjoy the remainder of the weekend.

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

Compass Closes Out Phase 3 With 6-Month COMP006 Data, Eyes H1’27 Launch

Psychedelic Alpha ↗

7 July 2026

Inside the NHS hospital trialling psychedelics to treat depression

Financial Times ↗

6 July 2026

Pα+ Psychedelic Bulletin #227: A Closer Look at Compass’ 6-Month Data; AtaiBeckley Deal Update; ‘Rysanso’ Brand MDMA?

Psychedelic Alpha ↗

8 July 2026

Documentary follows Colorado man's 500-mile run on psychedelics

Axios ↗

8 July 2026

FDA cracks down on illegal ketamine sellers amid nearing ‘psychedelic revolution’ - Pharmaceutical Technology

Pharmaceutical Technology ↗

8 July 2026

Psychedelics surge again as Compass, Definium provide more clinical validation

BioSpace ↗

9 July 2026

Beacon Hill starting to embrace pilot program for psychedelic mental health treatments

The Boston Globe ↗

9 July 2026