This Week in Psychedelics

FDA to review a psychedelic drug application for the first time ever. Could our industry be on the verge of a historic milestone?

May 10, 2024

This Week...

Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announced that the FDA’s Psychopharmacologic Drugs Advisory Committee will meet on June 4 to review the results of its clinical trials for the psychedelic-assisted therapy.

Not only will this be the first time in 25 years since the FDA has reviewed a new PTSD treatment option, but it’s the first time in history that the agency has taken up a new drug application for a psychedelic substance. Check it out:

Compass Pathways announced top-line results from an open-label phase 2 study evaluating the safety and tolerability of its investigational COMP360 psilocybin treatment in 22 patients with post-traumatic stress disorder (PTSD).

The study met its primary safety endpoint and available secondary efficacy endpoints. Study observations included meaningful and sustained symptom improvement from baseline in mean CAPS-5 total score, a measure of disease severity, and in Sheehan Disability Scale (SDS) score, a measure of functional impairment in daily life. Administration of COMP360 was well-tolerated, with a safety profile consistent with previous studies. Here’s more:

Worth noting, this news comes shortly after Morgan Stanley initiated coverage on Compass Pathways, with a $30 price target.

Reunion Neuroscience announced that it raised $103 million in a series A round, co-led by MPM BioImpact and the Novo Nordisk Foundation’s investment arm, Novo Holdings.

If you’re unfamiliar, Reunion is developing a novel psychedelic designed to treat adjustment disorder in cancer patients as well as postpartum depression. As we noted earlier in the year, there will be a lot of big money flowing into the space this year. And while $103 million isn’t trivial, it’s also just a small percentage of what will be invested in psychedelics this year. Here’s more:

Did You Know?

Did you know that microdosing LSD could help you sleep longer?

According to the results of a study published in the journal Translational Psychiatry, researchers found that compared to controls, participants who microdosed on LSD slept longer the next night, with no reduction in sleep observed on dosing days.

The analysis revealed a significant increase in REM sleep, time asleep, and total sleep on the night after microdosing with LSD compared to placebo. Check it out: