Compass Pathways reports completion of COMP360 psilocybin application

U.S. FDA approval is being sought for COMP360 psilocybin in treatment-resistant depression, according to a submission-completion announcement on Monday. Compass Pathways plc NASDAQCMPS said its application draws on two Phase 3 trials and a Phase 2b study involving more than 1,000 participants.

The Nov. 9 release announces completion without giving a separate date for the final submission. It is a company submission announcement, rather than an FDA acceptance or approval notice, and the application itself was not reviewed for this story.

Compass is a small, London-based biotechnology developer focused on mental health, with a U.S. office in New Jersey.

Shares closed at US$8.61 on Nasdaq at 4 p.m. EST on Nov. 6, according to the NASDAQCMPS quote page. That close precedes Monday's announcement; Compass continues to target a first-half 2027 launch, subject to FDA approval.

The submission completes a milestone flagged in the company's Nov. 3 business update, when it said the final application would be filed within two weeks. Rolling review was already underway, so completion follows an earlier process of submitting material in stages.

"We look forward to continuing the review process, and we are focused on delivering COMP360 to patients as quickly as possible, subject to FDA approval," Compass chief executive Kabir Nath said in Monday's release.

Application Follows Two Positive Phase 3 Trials

The second pivotal study, COMP006, dosed 581 participants, according to Compass's July 7 trial update. The randomized, double-blind study compared two fixed doses of 25 milligrams with two doses of one milligram, administered three weeks apart.

In its Feb. 17 primary-endpoint report, Compass said the higher-dose arm improved depression scores by 3.8 points more than the low-dose control at six weeks. The endpoint measured change from baseline on the Montgomery-Åsberg Depression Rating Scale, with a p value below 0.001.

The first pivotal trial, COMP005, compared a single higher dose with placebo. Its six-week treatment difference was 3.6 points in favour of COMP360, also with a p value below 0.001, according to the same report.

Safety remains part of the application assessment. In the July COMP006 update, Compass reported serious adverse events over 26 weeks in 5.7 per cent of the higher-dose arm and 6.3 per cent of the low-dose arm; common adverse events included nausea, headache, anxiety and visual hallucinations.

Commercial Spending Rises Ahead Of Planned Launch

The listed psychedelic-drug peer group includes Definium Therapeutics, Inc. NASDAQDFTX, which announced FDA breakthrough therapy designation on Sept. 8 for its investigational DT120 lysergide orally disintegrating tablet in major depressive disorder. Definium's designation supports expedited development and review; Compass's announcement concerns completion of a marketing application for treatment-resistant depression.

Compass reported US$444 million in cash and cash equivalents at Sept. 30 in its Nov. 3 update, with operations expected to be funded into 2028. Quarterly selling, general and administrative expenses rose to US$33 million from US$13.2 million a year earlier, reflecting commercial preparations ahead of potential approval.

The company said those preparations include provider training, reimbursement capabilities and supply-chain readiness. Its Nov. 3 update also cited a National Priority Voucher that could shorten review to one or two months, a company expectation rather than a stated FDA decision deadline.

Read more: Compass Pathways reports US$444M cash and runway into 2028

The next scheduled commercial milestone is the first-half 2027 launch target. Compass's July update identified both FDA approval and subsequent Drug Enforcement Administration rescheduling as conditions for launch.