Compass’ psychedelic-based depression treatment scores second late-stage study win

By Sahil Pandey and Christy Santhosh

Feb 17 (Reuters) – Compass Pathways said on Tuesday its psilocybin-based therapy eased depression symptoms in a late-stage trial, sending the drug developer’s shares up nearly 42%, as it aims to win approval for the first classic psychedelic treatment in the United States.

The therapy, COMP360, consists of a synthetic formulation of psilocybin, the active ingredient in “magic mushrooms”. It is designed as a short-term, episodic alternative to daily antidepressants for patients with hard-to-treat and long-lasting depressive episodes.

In the study, COMP006 involving 581 patients, two 25 milligram doses were given to patients three weeks apart, which led to a 3.8‑point greater reduction on a standard depression rating scale at six weeks compared to two 1 mg doses.

Compass said it used the very low dose as an active comparator to reduce the chance that patients or site staff could guess who received the higher dose.

Chief Executive Officer Kabir Nath said patients who respond can show improvement as early as the day after dosing, and that the effect can last.

In June 2025, the company said the first late‑stage study of a single 25 mg dose showed an improvement of 3.6 points in severity symptoms.

“With two positive late-stage studies and robust durability data, Compass is on track to be the first psychedelic approved by the FDA, likely in 2027,” said Cantor analyst Josh Schimmer.

If approved the treatment will compete with Johnson & Johnson’s ketamine-based Spravato, which brought in $1.7 billion in 2025 revenue.

COMP360 demonstrated durability that lasts at least through six months after only one or two administrations, the company said, comparing it with Spravato, which needs to be dosed every one to two weeks to maintain durability.

“Patients need 10 Spravato treatments by week six to achieve a similar effect to what we’re seeing with COMP360 at week six with one or two treatments,” Nath said.

The company has requested a meeting with the Food and Drug Administration to discuss a rolling submission and it expects to complete its application in the fourth quarter, with 26‑week COMP006 data due in the early third quarter.

Under a rolling submission the regulator assesses the data as and when it becomes available, and the process continues until there is enough data for a formal marketing application.

(Reporting by Sahil Pandey and Christy Santhosh in Bengaluru; Editing by Devika Syamnath, Shinjini Ganguli and Maju Samuel)