After the U.S. Food and Drug Administration (FDA) rejected Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder (PTSD) in 2024, other companies in the psychedelics field are preparing to move forward with their own therapies. Compass Pathways and Definium are both nearing regulatory milestones that could lead to the commercial launch of new treatments.
“This is a very big year for psychedelics,” said Patrick Trucchio, an analyst at H.C. Wainwright, in comments to BioSpace. “It’s the biggest year from a clinical data standpoint,” since his firm began covering Compass in 2018.
“With multiple late-stage data readouts and regulatory catalysts in 2026, we believe our coverage is well positioned to transition from ‘speculative’ clinical validation to large-scale market launch,” Trucchio and colleagues wrote in a note dated January 28.
Definium, previously known as MindMed, is expected to announce results from three Phase III trials for its LSD-based treatment DT120 for generalized anxiety disorder and major depressive disorder. RBC Capital Markets described these upcoming data as a possible “potential psychedelic space tipping point.”
Compass Pathways is also set to release multiple data updates this quarter for its psilocybin-based therapy COMP360 aimed at treatment-resistant depression (TRD). The company will present 26-week results from the Phase III COMP005 trial along with full data from Part A of both COMP005 and the parallel COMP006 trial, according to Steve Levine, Compass’s chief patient officer.
A recent investor event hosted by Compass shifted perceptions about these therapies from theoretical discussions to practical launch scenarios. H.C. Wainwright analysts noted that provider sentiment was “notably enthusiastic and proactive,” with several key opinion leaders calling COMP360 “a rare, field-defining innovation.”
Trucchio indicated that Compass is “very likely” to file for approval of COMP360 by the third quarter of this year, followed by Definium’s application for DT120. He predicted that by 2027 both treatments could be approved: “So by 2027, that’s a reality that DT120 and COMP360 are probably going to be approved.”
Policy shifts may also affect how quickly these therapies reach patients. Health Secretary Robert F. Kennedy Jr., who has criticized the FDA’s approach to psychedelic treatments, and FDA Commissioner Marty Makary have both shown support for expediting reviews of psychedelic therapies. In an interview last May with NewsNation, Makary said the FDA would “take an expeditious and rapid review” of clinical data for psychedelic therapies in trials.
Trucchio pointed out that changes within regulatory advisory committees could have mixed effects: “It wouldn’t surprise me if there’s a pretty significant change for the next neuropsych adcom that reviews [DT120] or COM360 . . . maybe building it with people who have a little bit more experience with psychedelics.” While this could benefit companies, he cautioned it might also raise expectations or demands.
The sector continues to recover after the FDA’s rejection of Lykos—now Resilient Therapeutics—primarily due to issues with trial design rather than doubts about psychedelics overall.
Other companies such as AtaiBeckley are also aiming for FDA approval as providers of classic psychedelics—a category distinct from Johnson & Johnson’s Spravato (esketamine), which received approval for TRD in 2019 but does not act on classic psychedelic pathways.
Spravato has laid some groundwork for reimbursement models relevant to new psychedelic therapies. During its investor event, Compass highlighted that COMP360's single-session six-week efficacy stands out compared to Spravato's approximately ten administrations over the same period. According to H.C. Wainwright, "with any durability beyond 6 weeks viewed as incremental upside rather than a prerequisite for reimbursement."
The FDA is particularly interested in long-term safety data regarding retreatment intervals up to twelve weeks using COMP360.
Investor response remains cautious following muted results when Compass announced six-week data from its Phase III COMP005 trial last June. Although primary endpoints were met, reductions on depression scales were less dramatic than earlier-stage studies had suggested—a trend Trucchio attributes partly to higher expectations fueled by early academic research showing high remission rates.
Delays may still occur even after FDA approval because both psilocybin and LSD remain classified as Schedule I drugs under federal law; rescheduling decisions by the Drug Enforcement Administration (DEA) could take up to ninety days after approval before states begin their own processes. About half of U.S. states have trigger laws aligning automatically with federal changes.
Trucchio described a fourth-quarter 2027 launch as “optimistic” even if filings proceed on schedule due to regulatory complexities around risk management strategies (REMS), scalability challenges related to lengthy treatment sessions compared with existing options like Spravato, and delivery logistics: clinics treating TRD patients can handle only limited numbers per day due in part to session duration differences among treatments.
Levine also drew attention to recent acceptance by the FDA of an Investigational New Drug application allowing late-stage testing of COMP360 in PTSD: “I think it can’t be overemphasized how important that is. That’s 13 million patients. There hasn’t been an approval there this millennium,” he said. “We are so excited about the potential for both TRD and PTSD now to potentially have new options for patients. This really can change and hopefully save the lives of lots of people.”
