Compass Pathways revealed that an FDA filing for COMP360 will be complete “in the next two weeks,” with an expected drug launch in the first half of next year. The update follows a reported regulatory submission for Usona Institute’s own psilocybin candidate for depression on Monday.
Compass Pathways expects to finalize a rolling submission for its highly anticipated psilocybin depression drug “in the next two weeks,” the company said Tuesday, possibly providing a balm for investors after its stock dipped Monday following news that Usona Institute had submitted an FDA approval application for its own psychedelic depression candidate.
Both Compass and Usona hold Commissioner’s National Priority Vouchers (CNPVs) for their candidates—Compass’ COMP360 for treatment-resistant depression (TRD) and Usona’s PSIL201 for major depressive disorder (MDD)—meaning that both could be approved by the end of the year.
“Confirmation that completion of [Compass’] NDA filing is expected very soon is reassuring, especially with reports that a non-profit (the Usona Institute) recently submitted NDA filing for their psilocybin MDD program,” Stifel analysts said in a note to investors Tuesday morning.
After multiple sources reported Monday that Usona had filed a new drug application for PSIL201, Compass’ shares dipped more than 35%. RBC Capital Markets suggested this might be reason to snap up Compass stock.
“With CMPS shares down today on potential increasing competitive concerns, we see a buying opportunity given we think even modest commercial success is not being priced in to shares at these levels,” the analysts wrote in a note to investors Monday afternoon. The analysts added, “Given the size of the market - we think there is room for multiple competitors.”
Compass rebounded somewhat after releasing third-quarter earnings on Tuesday but its shares are still 23% below where they started the week, sitting at $9.01 a pop as of publication.
As part of its earnings report, Compass said it was “on track” for an expected launch in the first half of 2027, subject to FDA approval. While the timing is still to be determined, the CNPV shaves review periods from 10–12 months down to 1–2 months. This “gives us more confidence approval [for COMP360] should firmly come within the 1Q27 timeframe (if not earlier) based on prior CNPV timelines,” Stifel analysts said in a Tuesday morning note.
The analysts added that the Usona filing “will be an overhang for a bit, though CMPS remains confident with NDA completion imminent.”
While both Compass and Usona’s psychedelic therapies target depression, they are for different indications, and Usona’s PSIL201 is a bit more of a mystery, according to Stifel.
“The Usona ph3 MDD data have never been disclosed, and while Compass did not comment directly on PSIL201, they did emphasize that the COMP360 data are inherently differentiated in that they come from a highly refractory TRD population,” the analysts wrote.
In a six-week, Phase 2 placebo-controlled trial of 104 adult patients with MDD, a 25-mg dose of PSIL201 met the trial’s primary endpoint by delivering “a rapid and sustained antidepressant effect . . . compared with active placebo,” according to a 2023 JAMA publication. There were no serious treatment-emergent adverse events (AE).
Meanwhile, in the Phase 3 COMP006 trial, 39% of patients with TRD who received two fixed doses of COMP360 achieved a clinically meaningful reduction in depression severity by week six, Compass reported in August. The patients who saw relief maintained a durable response through week 26. The drug’s safety profile was comparable to previous studies, with treatment-emergent AEs that were transient and typically occurred on the day of dosing, Compass said at the time.
