Compass Pathways highlights FDA Breakthrough designation as Trump orders faster psychedelic reviews

COMPASS Pathways is drawing renewed interest after highlighting progress in its late-stage program for COMP360, a psilocybin-based therapy for treatment-resistant depression, supported by an existing Breakthrough Therapy designation from the FDA. President Donald Trump signed an executive order April 18 directing federal agencies to accelerate research, regulatory review and access to psychedelic drugs, including ibogaine compounds, for serious mental illnesses.

The central value driver for COMPASS Pathways is COMP360 for treatment-resistant depression, which the company is pursuing through phase 3 clinical trials following positive phase 2b data reported in 2021 and discussed again in later regulatory and investor communications. A key milestone supporting investor interest has been the Breakthrough Therapy designation already granted by the FDA for COMP360 in treatment-resistant depression, which is intended to expedite the development and review of drugs for serious conditions.

The order prioritizes FDA review of psychedelic drugs that have received breakthrough therapy designation and directs issuance of vouchers for psychedelic drugs that have designated as a breakthrough therapy. The FDA and Drug Enforcement Administration are tasked with creating pathways for eligible patients to access psychedelic drugs under the Right to Try Act.

HHS will allocate at least $50 million from existing funds through the Advanced Research Projects Agency for Health to support state programs advancing these therapies. Federal agencies, including HHS, FDA and the Department of Veterans Affairs, are directed to expand clinical trial participation, data sharing and real-world evidence generation.

COMPASS Pathways focuses on developing psychedelic-based treatments for serious mental health conditions, with a primary emphasis on treatment-resistant depression. The company’s lead candidate, COMP360, is a synthetic formulation of psilocybin administered alongside psychological support sessions, designed to be delivered in specialized treatment centers.

Future revenue, if the therapy is approved, would likely stem from a combination of drug supply and fees for supervised treatment sessions carried out in accredited centers. The company has signaled that reimbursement discussions with payers will be crucial, given that a single supervised psilocybin session may involve several hours of clinician time and specialized infrastructure.