Compass Pathways (NASDAQ:CMPS) shares rose 14% after it reported first quarter results that topped expectations and showed continued regulatory progress for its lead therapy COMP360 in treatment-resistant depression.
For the quarter, Compass reported an adjusted loss of $0.30 per share, coming in ahead of analyst expectations of a loss per share of $0.43. The result reflected lower-than-expected operating costs alongside ongoing progress in its late-stage clinical programs.
Operating expenses declined year over year, with both research and development and general and administrative costs moving lower. R&D spending decreased as the company’s Phase 3 COMP360 program advanced toward completion, reducing clinical trial activity and related development expenses.
Compass ended the quarter with $466 million in cash and cash equivalents, supported by financing and warrant exercises, providing runway into 2028.
The company also said the FDA has granted a rolling New Drug Application (NDA) submission and review for COMP360, with portions of the filing already submitted. Compass also received a Commissioner’s National Priority Voucher (CNPV), which could materially shorten review timelines once the application is complete.
The company reiterated plans to finalize its NDA submission in the fourth quarter of 2026, with additional Phase 3 durability data expected in early Q3.
“With regulatory acceleration unfolding, we are working diligently towards our goal of completing the filing of a robust clinical package by Q4 and securing COMP360 approval,” Compass Pathways CEO Kabir Nath said in a statement.
“COMP360 represents a fundamentally different approach for patients with treatment resistant depression, unlike any other treatment approved today.”
Jefferies analysts said they see a high likelihood of FDA approval for COMP360 around year-end 2026, followed by DEA rescheduling and a potential commercial launch in early 2027. They highlighted the upcoming 26-week Phase 3 data readout as a key step enabling the rolling NDA completion and noted the CNPV could support a rapid one- to two-month review process.
The analysts described COMP360 as a potentially large commercial opportunity in treatment-resistant depression, comparing its infrastructure needs to existing esketamine-based therapies such as Spravato, and suggesting the treatment could be integrated into many of the more than 7,000 US treatment centers already operating in the space.
Jefferies said its base case assumes a launch in early 2027 with meaningful uptake supported by existing clinic infrastructure and reimbursement pathways, and sees long-term peak sales potential in the multi-billion-dollar range if adoption trends prove favorable.