Compass Pathways (NASDAQ:CMPS) said it has begun a rolling New Drug Application submission for COMP360, its investigational psilocybin treatment for treatment-resistant depression, and is preparing for a potential launch by the end of the year if the therapy is approved.
On the company’s first-quarter results conference call, Chief Executive Officer Kabir Nath said Compass has aligned with the U.S. Food and Drug Administration on a rolling submission and review plan for COMP360. He said the company has started submitting NDA modules and expects to submit additional modules over the coming months.
“With our COMP005 and COMP006 data announcement in February, we have delivered positive data from both our Phase III studies,” Nath said. “COMP360 has therefore demonstrated what no approved drug for TRD offers, clinically meaningful efficacy with both rapid onset and extended durability.”
FDA voucher could accelerate review timeline
Compass said it received a Commissioner’s National Priority Voucher, or CNPV, which could allow for an “ultra-accelerated” FDA review timeline after the final NDA submission.
Chief Commercial Officer Lori Englebert said one potential benefit of the voucher is a review timeline of one to two months after final NDA submission. Nath clarified during the question-and-answer session that Compass understands the formal one-to-two-month goal would begin after completion of the NDA submission, though he said the voucher has already led to more flexible communication with the agency.
Nath also said the CNPV does not change the evidentiary requirements needed for approval. “It’s been very clear in our discussions with the agency that in no way does it change the evidentiary basis that’s needed for an approval,” he said.
Asked whether the FDA might convene an advisory committee meeting for COMP360, Nath said that decision rests solely with the agency and would likely be made after it reviews the full data package. He said Compass is preparing for the possibility but has not received an indication either way.
Company works on DEA and state rescheduling
Because COMP360 is a Schedule I substance, Compass said it will need federal and state rescheduling after any FDA approval before the product can be prescribed. Nath said the company is accelerating engagement with the Drug Enforcement Administration following a White House executive order that highlighted timely rescheduling of approved treatments.
Englebert said Compass has been working at the state level for two years to prepare for rescheduling after federal action. She said nearly 90% of the U.S. population lives in a state that intends to reschedule COMP360 within 30 days after FDA approval and DEA rescheduling.
During the Q&A, Nath said the intended process could allow FDA and DEA conclusions to occur close together, though he said it would still be sequential. Compass expects to provide an Eight-Factor Analysis for review by FDA’s controlled substance staff, followed by DEA review.
Commercial launch preparations focus on treatment centers
Englebert said Compass remains focused on being launch-ready by the end of the year. She said the company is building its commercial organization, with a leadership team that has collectively launched more than 50 products, and said the commercial team has doubled in the past two months.
Compass is focusing its initial commercial strategy on interventional psychiatry treatment centers, which Englebert said currently account for the large majority of SPRAVATO treatment. She said academic centers treat less than 5% of SPRAVATO patients, while approximately 7,500 interventional psychiatry centers are already prescribing SPRAVATO.
Chief Patient Officer Dr. Steve Levine said those centers generally have infrastructure compatible with COMP360 administration. He said Compass expects SPRAVATO rooms and staffing models to be similar to what will be needed for COMP360, allowing treatment rooms to be used interchangeably.
Levine also said the company has engaged with the “vast majority” of relevant sites through strategic collaborations, its medical science liaison team and other relationships. He said many centers are eager for additional treatments for treatment-resistant depression and would be ready to adopt COMP360 if approved.
Reimbursement and REMS planning continues
Compass executives discussed efforts to support reimbursement for both COMP360 and the clinical monitoring time required during treatment. Englebert pointed to psychedelic-specific CPT III codes, which she said were designed to cover clinical work and practice expenses for multi-hour psychedelic treatments.
Levine said the codes are currently in Category III tracking form and would need to be reported in larger numbers after approval and launch before they can progress toward Category I valuation. He said providers may negotiate directly with payers for reimbursement before that process is complete.
Asked about a Risk Evaluation and Mitigation Strategy, or REMS, Levine said Compass has been guided to expect a REMS consistent with SPRAVATO’s existing REMS and FDA briefing materials prepared for Lykos’s advisory committee. He said the REMS would likely address key safety elements such as a prescriber being available and a licensed healthcare provider being on site, but would not dictate detailed practice-of-medicine requirements such as the exact number or length of preparation sessions.
Compass said it is also beginning payer discussions, though Englebert said formal negotiations will wait until the company has a clearer full clinical profile for COMP360, including longer-term durability and redosing data.
PTSD program advances as next target indication
Beyond treatment-resistant depression, Compass said it is progressing development of COMP360 in post-traumatic stress disorder, which Nath said affects 13 million Americans. The company said work with its contract research organization and trial sites is underway for a late-stage PTSD study.
Nath said Compass is planning the PTSD program around a single late-stage trial, though he noted that ultimate requirements will depend on FDA review and the resulting data. The primary endpoint will be CAPS-5, a standard and validated PTSD measure, he said.
Levine said Compass is already engaged with the Department of Veterans Affairs and is supporting VA studies, including a multi-site study in patients with treatment-resistant depression and PTSD comorbidities. He said the company is supplying drug and training for an initial cohort of trainers.
Nath said Compass ended the first quarter with a strong balance sheet following financing and warrant exercises, with cash expected to carry the company beyond launch and into 2028.
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.
