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This morning, Compass Pathways announced that it is preparing to launch its psilocybin therapy (COMP360) for treatment-resistant depression (TRD) at least nine months earlier than previously planned, following a “positive” September meeting with FDA.
“We’re excited, we think this is great news”, Compass CEO Kabir Nath told Psychedelic Alpha this morning. “This is a potential acceleration by certainly nine months or so”, he continued, with a related press release stating that the company is accelerating its commercial launch plans by 9-12 months.
Part of that acceleration, Nath told us, is down to the willingness of the FDA to accept a rolling submission of Compass’ new drug application (NDA), as opposed to waiting to accept the full package following the completion of all sections. Aside from the agency’s apparent interest in reviewing the package, Compass is also set to read out data from its Phase 3 program ahead of schedule, which is also expected to contribute to that earlier-than-expected potential launch.
Here, we delve much deeper into this breaking news, which we discussed with the Compass CEO, Nath, earlier this morning…
FDA Meeting Opens Door to Rolling Review, Compressing COMP360’s Launch Timeline
The psilocybin drug developer met with FDA in September to discuss its first Phase 3 readout and NDA submission strategies, including the potential for rolling submission.
Usually, sponsors are expected to complete all sections of an NDA before submitting it for review. But a rolling submission, as the name suggests, allows a sponsor to submit sections of the NDA as they are finalised. A company could, for example, submit its chemistry, manufacturing and controls (CMC) and nonclinical modules before the clinical section is ready, in the hopes that FDA begins reviewing those parts right away.
If FDA does choose to commence its review upon receipt, it might also send sponsors Information Requests, which could nip questions or points of clarification in the bud.
What’s more, while FDA usually expects sponsors to submit complete sections, it does leave the door open for agreements with sponsors that could see subsections, or otherwise incomplete sections, submitted to the agency. That could, theoretically, allow the FDA to review an incomplete clinical section.
Indeed, Nath told us that the agency has indicated a willingness to review clinical data as the company reads out. “That was actually very positive”, Nath said, and means Compass can now unblind 9-week Part A data from the second, larger study in its Phase 3 program significantly ahead of schedule (more on this below).
Rolling review is only available to programs with Fast Track or Breakthrough Therapy Designation. Compass secured the latter in 2018, and today half a dozen psychedelic drug development programs have the designation. (MAPS received a rolling review grant in November 2021 for its then-planned and ill-fated MDMA for PTSD NDA.) For more, see FDA Guidance for Industry: Expedited Programs for Serious Conditions (May 2014)
Following that meeting with the agency, Compass is now touting this potential 9-12 month reduction in its launch timeline. If it materialises, it is nothing but a major win for Compass.
But it’s not clear just how much rolling review in itself will contribute to this accelerated timeline, as there is very little precedent to go on, at least in psychiatry.
Nath pointed to action dates in other Divisions that came just a couple of months after the final submission of an NDA that had benefited from rolling review1, though he was clear to add that the company is not suggesting that it expects that sort of timeline.
The new launch timeline expectations are a result not only of rolling review, then, but also the progress of the second, larger Phase 3 study.
A Revamped Readout Schedule
In terms of its Phase 3 program, the psilocybin drug developer has only shared a topline readout from the first of two studies, COMP005 (n=258), thus far. That June announcement revealed that the 25 mg psilocybin arm separated from placebo, with a statistically significant and clinically meaningful 3.6-point between-group difference on the MADRS at week 6, the primary endpoint.
Despite clearing those hurdles, shares in the company dropped on the news, with some hoping for a larger antidepressant effect.
But Nath tells us that the readout was viewed as positive among physicians and providers, which led to accelerated recruitment over the summer, particularly in Europe. That, combined with learning “tough” lessons from the first Phase 3, has improved execution of the second study, Nath suggested, which might now pay dividends in terms of earlier-than-expected readouts.
A lot is riding on Compass’ ability to show an additive benefit of additional doses, and a dose-response effect, in that second Phase 3 study.
9-week (Part A) data from that trial, COMP006 (n=585), along with 26-week (Part B) data from COMP005, is now expected in Q1 2026, the company said today. These readouts shave a little off our projected timeline, especially as Part A of ‘006 was previously only expected to be read out following the completion of Part B of that study, which follows patients out to week 26.
What’s more, that final tranche of data from the program—26-week data from COMP006—is expected in “early Q3 2026”, the company also said this morning, adding that it has completed enrolment for the study. It had formerly provided H2’26 guidance, so this early Q3 guidance appears positive and, again, trims that launch timeline.
“If we get there by the end of next year, that would be fantastic”
Given this accelerated readout timeline and the agency’s apparent interest in a rolling review, the natural question is: 9-12 months earlier than when, exactly? i.e., when might we expect COMP360 to launch, if approved?
Compass, like almost any sponsor, has been careful to avoid giving guidance on an expected approval or launch timeline, but some napkin math has suggested a launch sometime in late 2027 or early 2028 was on the table.
That math assumed the company would need to have data from both Phase 3 studies in hand before submitting the NDA. Given the crucial 26-week data from its second Phase 3, COMP006, was expected to be ready for readout in the H2’26, one might have projected the earliest submission of the NDA to be later in the second half of 2026 or the first half of 2027.
Thereafter, one might have expected the NDA to benefit from priority review, which aims to reduce FDA’s review time from a 10-month target to 6 months. It is not a given that Compass will receive priority review, though we had deemed it very likely.
Assuming a 6-month review, then, plus federal rescheduling processes in the event of an approval which could take up to 90 days as well as rescheduling efforts in some states, we were anticipating any launch to happen in late H2’27 at best, with most analysts deeming H1’28 to be the base case.
With Compass now bringing its launch planning forward by 3 or 4 quarters, the company appears to be eyeing an H1’27 launch, or even H2’26, if everything falls into place.
“If we get there by the end of next year, that would be fantastic”, Nath told us, while appearing to guide that Q1’27 might be a more realistic target.
No Small Feat
Bringing forward launch plans by as much as a year is no small feat, especially for a first-in-class therapy that already has no shortage of commercialisation-related quirks and unknowns.
“It’s a lot of work,” Nath acknowledged, adding that the team is very excited. “If you’re working in psychiatry, not that many people get to work on filing at all, that’s unfortunately the reality.”
On the cash front, Compass said that its $185.9 million position at quarter-end “is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2027.” Time is money, especially for pre-revenue drug developers, so the potential for an expedited launch timeline is welcome news for Compass and its backers.
Nath told us that the company is looking to hire a handful of key commercial roles in short order, “but fundamentally we’re going to wait for data in quarter 1 before we do any more of that.” There will be “some very modest incremental commercial spend,” he added, “and some appropriate additional spending on regulatory, quality, and so on.”
Among that launch planning, Compass hopes to secure a U.S. source for its psilocybin. “Our head of manufacturing has moved to the U.S., and his primary job is to source US manufacturing”, Nath told Psychedelic Alpha today. President Trump has made it clear that the country will favour domestic production of drugs.
The company is also hoping that the rescheduling process might be accelerated, though it is not banking on it. Nath pointed to the Association of Prescription Psychedelics, which represents most late-stage psychedelic drug developers, which has put forward wording to suggest that rescheduling could move in parallel with FDA’s final review, as opposed to tacking on up to 90 days to the launch timeline after FDA reaches an approval decision, as is customary.
It would be “icing on the cake”, Nath told us.
Outside of the TRD program, Compass has also provided an update on its PTSD project. In June, Chief Medical Officer Guy Goodwin told us that the company was on track to sign contracts with a CRO by year-end to launch a late-stage PTSD trial. The CRO is on board, Nath told us today, and the company is finalising the trial’s design. Compass expects to host an event with PTSD KOLs and patients in the new year. It also hopes to have the first patient enrolled in Q1 2026.
Pα: Since RFK Jr. took the helm at the Department of Health and Human Services earlier this year, many expected to see agencies like the FDA look to catalyse psychedelic research and drug development. Perhaps conscious of a lack of clear action in that regard, in late June, the HHS Secretary proclaimed at a House hearing that he and his colleagues were “working very hard” to provide some access to psychedelics “within 12 months”.
The comment was lacking in detail, and it is very unlikely that Compass will come to market this side of June 2026, but it does appear that something has significantly catalysed the psilocybin drug developer’s launch plans.
Whether the credit for that should lie at the feet of the drug developer, the normal course of the FDA’s Breakthrough Therapy Designation program and Division of Psychiatry’s review processes, or the current administration’s particular interest in this class of drugs, might never be known. But many will assume that now, after plenty of talk, FDA is acting on what appears to be a political priority.
The Compass CEO, Nath, thinks it’s a bit of both. He says that his company’s execution of its second, much larger, Phase 3 study is benefiting from hard lessons learned during the first. He also says that the positive readout from that first study has buoyed provider interest and accelerated recruitment in COMP006.
But he also acknowledged the agency’s clear interest in the class.
“There is a real sense that psychedelics are the only class within psychiatry that’s actually producing significant positive results at scale”, he told us this morning. “So I think a lot of this is the agency recognising that to do the right thing for patients, they need to be actually engaging very appropriately but aggressively with psychedelics”, he added.
Still, Nath emphasised his belief that the company is conducting large, well-controlled Phase 3 studies, “so this is not exceptionalism, or asking for shortcuts.” He also noted that, despite the new administration’s interest in the class, the company has “always had good engagement with the Division, and that remains the case.” “I think, maybe uniquely for now, [the Division of] Psychiatry has really had no changes since January”, he added, suggesting that the lack of turnover among the team and reviewers in the Division has been a positive.
“They clearly believe that we have conducted robust, rigorous studies”, the CEO told us. “Obviously, they need to see the data, like all of us,” he went on, “but I think they are very open to something that’s much more aggressive around a rolling review, rolling submission.”
While this morning’s announcement from Compass is certainly positive, it is by no means a guarantee that its psilocybin candidate will launch at all, let alone 9-12 months earlier than planned. Indeed, the readout from its second, larger Phase 3 study remains crucial. It is also the case that the company has an enormous amount of work to do to launch its psilocybin therapy, which is by no means a conventional pharmaceutical product.
But today’s announcement is nothing but a major win for the company. The front-runner for FDA approval of a psychedelic drug has now gained a significant lead, and psilocybin could be approved by the agency as early as next year.
“I think that they see that patients are waiting and this is all great data we’re generating,” Nath said of the agency, “so let’s get on with it.” ∎
