Compass Pathways Eyes Q4 FDA Filing for Psilocybin Depression Drug After Phase 3 Wins

Key Points

• Compass Pathways said it remains on track to file a New Drug Application for COMP360 in Q4 after reporting highly statistically significant Phase 3 results in treatment-resistant depression, with a strong safety profile.
• Executives highlighted the drug’s potential commercial edge, saying COMP360 has shown efficacy in under 24 hours and durability for up to six months after one or two doses, compared with currently available treatments like SPRAVATO.
• The company is already pursuing a rolling FDA submission and is preparing for post-approval steps such as DEA rescheduling, site training, and REMS requirements, while also pointing to PTSD as a major future opportunity.

Compass Pathways NASDAQ: CMPS executives said the company remains on track to target a fourth-quarter New Drug Application filing for COMP360, its synthetic psilocybin treatment candidate for treatment-resistant depression, while preparing commercially for a potentially accelerated regulatory timeline.

Speaking at a company news event, Chief Financial Officer Teri Loxam said Compass has completed primary endpoint readouts from two Phase 3 trials in treatment-resistant depression, with six-week data from both studies showing “highly statistically significant” positive results and a “really strong safety profile.” The company has also reported six-month data from its first Phase 3 trial and expects six-month data from the second Phase 3 trial in early third quarter.

“We believe already that we have a really strong profile emerging for psilocybin and for COMP360,” Loxam said.

Executives Highlight Durability and Commercial Potential

Lori Englebert, Compass Pathways’ chief commercial officer, said the emerging product profile for COMP360 is differentiated from currently available options for major depressive disorder and treatment-resistant depression. She pointed to Johnson & Johnson’s SPRAVATO as the only pharmacologic product currently indicated for treatment-resistant depression, saying it is projected by J&J to reach $3.5 billion in revenue in 2028.

Englebert said SPRAVATO’s growth has helped build an infrastructure for multi-hour, in-office psychiatric treatments, including SPRAVATO, transcranial magnetic stimulation and electroconvulsive therapy. She said more than 4,000 sites were added in 2025 with the capability to prescribe these types of treatments.

Compared with SPRAVATO, Englebert said COMP360 has shown efficacy in less than 24 hours and durability out to six months after one or two treatments, based on data seen to date. She said SPRAVATO treatment durability is “at best two weeks,” with treatment often starting twice weekly and continuing weekly or every other week over time.

“To be able to have comparable efficacy from a treatment that’s only one or two treatments over six months is really truly gonna revolutionize the psychiatry industry,” Englebert said.

Upcoming Data Expected to Inform Dosing and Payer Discussions

Loxam said the upcoming COMP006 Part B six-month data is expected to help inform payer discussions and provide more clarity on dosing regimen, rather than serve as a readout with a specific efficacy threshold.

She said COMP005 evaluated a single dose versus placebo, while COMP006 evaluated two fixed doses three weeks apart versus an active comparator. According to Loxam, about 25% of participants in COMP005 reached a clinically meaningful response that was durable through six months. In COMP006, she said that figure increased to almost 40% with two doses up front, suggesting a positive impact from the second dose.

Part B of COMP006 allows patients the potential for a third dose in the first six months. Loxam said the data will help the company understand treatment trends across one, two or potentially three doses and may help inform labeling and payer strategy.

Loxam also said Compass has started submitting data to the FDA as part of a rolling submission and review process. The company has 52-week follow-up planned for both trials, though the timing of any public disclosure of the COMP005 52-week data remains under review as the company works to optimize the FDA submission process.

FDA Review and DEA Rescheduling Remain Key Steps

Loxam said Compass has had a stable and collaborative relationship with the FDA’s psychiatric division, despite broader uncertainty at the agency. She said the company received rolling submission and review authorization after February data and that discussions about accelerating the timeline had been underway since last fall.

The company also has Breakthrough Therapy designation, and Loxam said a Commissioner’s National Priority Voucher could potentially shorten the back end of the review process from a roughly six-month review timeline to a target of one to two months. She also said an executive order directed more efficiency around DEA rescheduling, which could help pull forward timelines after approval.

Englebert said that, after FDA approval, DEA rescheduling at the federal level is required before state-level rescheduling can occur and the product can be distributed and prescribed. She said the DEA typically completes scheduling reviews in about 90 to 95 days, though the company is assessing whether recent executive action could shorten that timeline.

Englebert said close to 90% of the U.S. population lives in a state that intends to reschedule within 30 days of federal action, compared with about 45% two years ago. The company expects to use the time between approval and launch to train sites, onboard a sales force and prepare compliant promotional activities.

REMS Expectations and Site Capacity

Steve Levine, Compass Pathways’ chief patient officer, said the company expects any risk evaluation and mitigation strategy, or REMS, to be broadly consistent with the framework used for SPRAVATO, though the details remain subject to FDA discussions.

Levine said the SPRAVATO REMS has not been a major barrier to site adoption. He said a potential REMS for COMP360 may include requirements for site certification, patient enrollment in a registry and monitoring during administration sessions, while focusing on safe use rather than the practice of medicine.

Levine and Englebert also said many interventional psychiatry centers have been built in anticipation of multiple new in-office treatment options. Levine said these sites are not operating at full capacity and many have available rooms that could accommodate COMP360 without displacing SPRAVATO or other treatments.

PTSD Program Cited as Next Major Opportunity

Levine also discussed Compass’ PTSD program, citing a large unmet need and few approved options. He said there are 13 million U.S. adults living with PTSD, compared with 4 million living with treatment-resistant depression, and that there has not been a new PTSD approval in more than 25 years.

Levine said Compass’ Phase 2A PTSD study, published last year, was primarily designed to evaluate safety and feasibility but included an efficacy endpoint showing more than 80% of participants in remission after a single treatment.

He said the PTSD program has synergies with treatment-resistant depression because patients are often treated in the same locations and the conditions are frequently comorbid. Levine also said Compass has been working closely with the VA, including supporting investigator-initiated studies and meeting regularly with a VA integrated project team focused on psychedelics implementation once approved.

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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