COMPASS Pathways

Compass Pathways has awarded Strata Mental Health Solutions one of five U.S. training grants to support the development of training programs for the investigational psilocybin treatment COMP360. Strata will provide structured training and certification for multidisciplinary treatment teams, based on the administration model used in the trials and led by clinical instructors from the COMP360 program. Compass reported positive Phase 3 results and is targeting an NDA submission to the FDA in Q4 2026, with a planned market launch in the first half of 2027. » Mere på de.investing.com

COMPASS Pathways provided an update on COMP360 for treatment‑resistant depression at the Cantor Healthcare Conference and launched a Phase III program for PTSD. The company expects a potential market launch in the first half of 2027 and reports an MADRS advantage of 3–4 points versus placebo, with rapid onset within 24 hours and durations of effect of up to one year. COMPASS presented reimbursement plans, new CPT codes, a buy‑and‑bill model, and preparations for REMS certification and DEA rescheduling, but still sees risks around the FDA timeline, rescheduling, and payer access. The stock reacted negatively and closed at $14.22. » Mere på de.investing.com

Compass Pathways' stock rose to a 52-week high of $15.40 and was last quoted at $15.42 with a market capitalization of about $2.11 billion, after gaining 172% over the past year. InvestingPro rates the stock as overvalued and points to high volatility (beta 2.55). Compass reported positive long-term results from Part C of the phase-3 study of COMP360, with an average 13-point reduction on the MADRS after 52 weeks, and disclosed cash holdings of $433 million, which are expected to fund operations through 2028. Jefferies reiterated a buy rating with a $18.00 target and sees a 75–85% probability of FDA approval; Oppenheimer maintained an outperform rating with a $20.00 target. » Mere på de.investing.com