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Key Points

• Compass Pathways reports more than 800 patients enrolled across two Phase 3 TRD trials, says both trials hit highly statistically significant primary endpoints, has a rolling FDA submission underway and expects to be launch ready by the end of this year.
• Other developers are advancing pivotal programs: Definium expects three pivotal readouts in 2Q–3Q, AtaiBeckley plans to start a Phase 3 for BPL‑003 this quarter with a Phase 2b readout for VLS‑01 later in the year, and Helus (formerly Cybin) has a deuterated psilocin in Phase 3 and additional trials planned.
• Panelists praised constructive FDA engagement but cautioned that the impact of the president’s executive order on rescheduling is uncertain and that DEA coordination and sequential agency processes remain key regulatory bottlenecks.

Executives from several psychedelic drug developers said they are pushing forward with conventional, large-scale clinical programs and preparing for potential shifts in the U.S. regulatory landscape during a panel discussion at the Psychedelics Forum.

The session, moderated by an event operator identified as Ami, followed news the operator described as a “significant boost” for the sector: an executive order signed by President Trump directing the FDA to accelerate approvals for psychedelic drugs and the FDA’s issuance of “a Commissioner’s National Priority Voucher to three companies.” The operator said one voucher recipient was represented on the panel by Kabir Nath, CEO of Compass Pathways NASDAQ: CMPS .

Compass highlights phase 3 progress and launch preparations

Nath said Compass is conducting what he called “the largest psychedelic development program to-date,” with more than 800 patients enrolled across two phase 3 trials in treatment-resistant depression (TRD). He said the company has “declared the primary endpoint of both those trials, highly statistically significant results in treatment-resistant depression.”

Compass is already “aligned with the agency on a rolling submission and rolling review,” Nath said, adding that the rolling submission is underway. He also said the company has been preparing for commercialization: “Our messaging has been consistent now for a number of months that we will be launch ready by the end of this year.”

In discussing potential acceleration, Nath said the company would be ready and noted the executive order’s focus on rescheduling. “We’re also excited to see whether in fact rescheduling can be moved up,” he said. Nath emphasized that the company has “modules already written, ready to be submitted,” and described building out commercial leadership and third-party vendor relationships for a complex launch.

Other developers outline pivotal timelines and portfolio strategies

Rob Barrow, CEO of Definium, said the company is developing an orally disintegrating tablet (ODT) form of LSD (lysergide tartrate). He said Definium expects “three pivotal readouts, one in major depressive disorder and two in generalized anxiety disorder,” in the second and third quarters of this year, and plans to “move aggressively” toward filing if results are positive.

Srinivas Rao, co-founder and CEO of AtaiBeckley, said his company is pursuing a portfolio approach, including short-duration psychedelic compounds. He highlighted BPL-003 (5-methoxy-DMT delivered intranasally) and VLS-01 (DMT via a transmucosal oral route), both in TRD, plus an R-MDMA program in social anxiety disorder. Rao said the company expects to initiate a phase 3 program for BPL-003 this quarter and anticipates a phase 2b readout for VLS-01 later this year.

Atul Mahableshwarkar, SVP of Clinical Development at Helus Pharma (formerly Cybin), said Helus has two assets: a deuterated version of psilocin in phase 3 and a deuterated version of DMT with data from an earlier-phase trial. He said Helus plans to start another trial later this year in anxiety disorders.

Regulatory engagement and the unresolved question of rescheduling

Panelists broadly praised engagement with the FDA’s Division of Psychiatry. Barrow described “thoughtful, sort of detailed, coherent engagement,” and said Tiffany Farchione had participated in every Definium pre-IND discussion, providing “an extraordinary amount of time and effort and energy.” Rao and Mahableshwarkar similarly cited consistent and constructive FDA interactions, including in programs with Breakthrough Therapy Designation (BTD).

However, they flagged challenges involving the DEA. Rao said “intra-agency communication” can be problematic, citing inconsistent experiences around protocol amendments and review expectations, and argued that anything clarifying how the DEA approaches the space “would be huge.” Mahableshwarkar said trial operations can be complicated by the need for both state and federal DEA approvals that “don’t necessarily go in lockstep.”

On whether the executive order will materially speed rescheduling, panelists said it is too early to know. “The devil is in the details,” Barrow said, noting that implementation in regulations and policy can take time. Nath said FDA and DEA perform similar analyses but, by statute, do so sequentially, and suggested parallel work “seemed logical,” while cautioning the industry would need to see how changes are “codified.”

Trial design: panelists downplay “functional unblinding” as a unique risk

Asked about functional unblinding—patients or staff inferring treatment assignment due to noticeable drug effects—panelists argued it is not unique to psychedelics. Mahableshwarkar said many psychiatric drugs create obvious effects at certain doses, calling unblinding “more of a perception” issue in psychedelics due to stigma and past experiences.

Speakers described mitigation steps that have become common in their trials, including using central raters “far removed from the sites,” separating efficacy assessment from staff who might observe acute effects, and measuring whether patients guessed their assignment. Barrow was blunt: “Every drug in psychiatry deals with this.” Nath said companies are measuring it but agreed it “really should be a non-issue.”

Rao distinguished patient unblinding from concerns raised around therapist unblinding in other programs, noting that if the same therapist provides extensive pre- and post-session interaction, that creates a different bias risk—one he characterized as distinct from typical patient-side unblinding issues.

Commercial adoption: infrastructure, durability, and practice economics

On commercialization, Nath pointed to the expansion of “interventional psychiatry” infrastructure since the 2019 launch of Spravato, estimating “somewhere between 7,000 and 8,000 centers” can theoretically deliver office-based treatments of this type, with about 1,000 doing most of the volume. He said this growth benefits future psychedelic launches, as Spravato sites could become early adopters.

Panelists said the biggest commercial differentiators will likely include magnitude and durability of benefit and the practicality of administration. Barrow argued that “how much better people get for how long” is a major driver, noting the current burden of frequent visits for ketamine or intranasal esketamine. Rao said AtaiBeckley’s short-duration strategy is designed to fit within a two-hour monitoring paradigm similar to Spravato, and said the FDA has been comfortable with a two-hour discharge in BPL-003 phase 3 “assuming that the patient meets discharge criteria.”

On payer adoption, Nath said payers are “absolutely aware of this coming class” but will need to see outcomes and economics. He said TRD patients can be costly for payers due to extensive healthcare utilization, and that developers are building models to support coverage discussions. Barrow, meanwhile, warned that legacy practices—such as requirements derived from earlier academic approaches—could become barriers if imposed broadly, stressing the need to balance safety with access and scalability.

Finally, Nath cited Compass’ work to secure a CPT code “specific to the provision of psychedelic medicines” as a foundational step for clinic economics. He said Compass has modeled that, if durability with limited administrations holds, the practice model can be compelling, adding that drug-and-procedure reimbursement combinations exist widely across medicine. Barrow agreed that while “there’s a ton to be done,” much of it is consistent with the normal mechanics of launching a drug, including billing and provider incentives.

About Compass Pathways NASDAQ: CMPS

Compass Pathways NASDAQ: CMPS is a clinical-stage biotechnology company focused on the development and commercialization of psilocybin therapy for mental health disorders. Founded in 2016 and headquartered in London with additional offices in the United States, Compass Pathways is pioneering the use of synthetic psilocybin combined with psychotherapy to address treatment-resistant depression. The company’s flagship program is a Phase IIb clinical trial evaluating COMP360, its proprietary psilocybin formulation, which has received Breakthrough Therapy designation from the U.S.

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