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November 9 – 15, 2026
November 2 – 8, 2026
A Note From the Editor
It’s been a busy week, with two psilocybin packages now well on their way to an FDA decision.
On Monday, we reported that Usona Institute has filed its new drug application (NDA) for psilocybin in major depressive disorder (MDD), according to sources familiar with the matter. The next morning, Compass Pathways told investors that its NDA, for psilocybin in treatment-resistant depression (TRD), will be filed within two weeks.
Both companies hold Commissioner’s National Priority Vouchers, which aim to shorten review times to just one or two months. Add in Resilient Pharmaceuticals’ refiled MDMA package, and FDA could hand down as many as three psychedelic decisions over the next few months.
It was a busy week beyond the psychedelics field, too, with the news cycle dominated by the U.S. midterm elections, in which Democrats won control of both the House and Senate. In our latest Bulletin, we look at what that shift in power and politics might mean for psychedelics.
Elsewhere in the Bulletin: FDA has responded to a letter that 32 House lawmakers sent it in May; a judge has set a September 2027 trial date in Terran Biosciences’ trade secrets suit against Compass; we look at what ICER’s 2019 review of Spravato might tell us about its review of Compass’ psilocybin; and much, much more.
If you’re more of a listener than a reader, Episode 4 of The Psychedelic News Feed Podcast was published on Monday.
Two quick reminders: ICER’s comment period on its draft scoping document for Compass’ psilocybin closes this Tuesday, November 10th, and FDA’s ibogaine request for information closes on November 20th.
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
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