CMPS

What is the expected timeline for Phase 3 trials, regulatory approval, and potential commercial launch of COMP360 for PTSD?

Created September 02, 2025 at 10:38 AM

Expected development timeline

Phase‑3 trial start‑up: Compass Pathways has said the Phase‑2 read‑out will be used to design the pivotal Phase‑3 program. In the biotech‑sector, moving from Phase‑2 data publication to a Phase‑3 start typically takes 12‑18 months (study‑design, site selection, regulatory filings and financing). Given the positive safety signals disclosed in May and the rapid publication this week, the earliest realistic launch of a Phase‑3 trial would be late 2025 – early 2026.
Regulatory review and BLA filing: Assuming the Phase‑3 program runs a standard 12‑month enrollment and a 12‑month primary‑endpoint read‑out (consistent with other CNS‑indication trials), the company could file a Biologic License Application (BLA) or NDA in late 2026 – early 2027. The FDA typically grants a standard review (10 months) or a priority review (6 months) for breakthrough mental‑health therapies; if COMP360 qualifies for priority review, approval could be expected by mid 2027.
Potential commercial launch: After a successful regulatory decision, commercial rollout would require manufacturing scale‑up, payer strategy and commercialization partnership. Industry experience suggests 6‑9 months post‑approval to reach market. Consequently, the earliest realistic launch of COMP360 for PTSD would be late 2027 to early 2028.

Trading implications

Short‑term catalyst: The Phase‑2 publication is a positive, but the key driver will be the Phase‑3 design announcement (likely in the next 3‑6 months). A clear, timelines‑driven update could trigger a 10‑15 % move up if the trial is sizable and well‑structured, while any ambiguity may keep the stock in a tight range.
Valuation: With the projected 2027‑2028 launch, the present‑value of expected cash flows from a PTSD‑therapy is still far out. The market is pricing in the high‑risk, long‑tail nature of mental‑health psychedelics (CMPS trading at ~ $2‑$3 per share). A mid‑term rally would be justified only after a firm Phase‑3 start date and a credible FDA interaction (e.g., a Type A meeting). Until then, maintain a cautious, range‑bound stance and consider hedging with a modest defensive position (e.g., a tight‑spread or partial position in a broader mental‑health ETF).
Risk factors: Delays in Phase‑3 enrollment, FDA skepticism on a synthetic psilocybin molecule, or competitive psychedelic pipelines (e.g., MAPS, Compass’s own earlier natural‑compound programs) could compress the timeline or depress valuation. Keep an eye on any regulatory correspondence releases from the FDA in the next 12 months as the primary risk monitor.