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. » More on 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. » More on 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. » More on de.investing.com

Compass Pathways, in collaboration with the U.S. Department of Veterans Affairs, is launching the multicenter, double-blind, randomized PIVOT study to evaluate COMP360 psilocybin in veterans with treatment-resistant depression, including those with comorbid PTSD. Two doses of COMP360 will be compared, with an option for a second unblinded dose after four weeks; the primary endpoint is depression severity measured by MADRS. Compass will supply the drug as well as training and counseling materials; the study will run at five VA sites under the lead of the Birmingham VA Health Care System. » More on de.investing.com

A post-hoc analysis of an open-label phase 2 study of COMP360 in PTSD found that 78% of treatment sessions took place in silence and verbal interactions between participants and therapists were minimal. Support was predominantly non-directive and focused on presence, soothing and affirmation to promote autonomy in the introspective state. Compass Pathways has established a training and mentoring program for therapists; COMP360 holds Breakthrough Therapy designation in the US and an innovative approval in the UK for treatment‑resistant depression. » More on de.investing.com