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Compass Pathways to expedite launch timing of its experimental depression therapy
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Compass Pathways to expedite launch timing of its experimental depression therapy
Nov 4, 2025 3:55 AM

Nov 4 (Reuters) - Drug developer Compass Pathways ( CMPS )

said on Tuesday it is pulling forward the expected

launch timing of its experimental psilocybin-based depression

therapy by 9 to 12 months.

The decision follows the completion of enrollment for a

late-stage study for the psychedelic-based therapy, COMP360, as

well as a positive meeting with the U.S. Food and Drug

Administration on strategies for its marketing application,

including a potential rolling submission.

CONTEXT

The experimental therapy called COMP360 is based on the

psychedelic compound called psilocybin and is designed as a

short-term, episodic alternative to daily antidepressants.

The company is testing the therapy in patients with

treatment-resistant depression, a condition in which patients do

not respond adequately to at least two different treatments.

In June, data from a late-stage study showed the therapy

reduced the severity of depression symptoms in a closely watched

study, but fell short of market expectations. Wall Street

analysts, however, said the data indicated that COMP360 might

get approved.

WHY IT'S IMPORTANT

The fast-growing market for psychedelic-based treatments for

psychiatric conditions could be worth up to $50 billion,

according to analysts.

Earlier this year, AbbVie ( ABBV ) said it would buy an

experimental psychedelic-based depression drug from Gilgamesh

Pharmaceuticals for up to $1.2 billion.

Atai Life Sciences ( ATAI ), Cybin and MindMed

are among other companies developing psychedelic-based

treatments for psychiatric conditions.

WHAT'S NEXT

Compass plans to announce 9-week data and 26-week data from two

separate late-stage studies testing COMP360 next year.

The company is also testing the drug as a treatment option

for post-traumatic stress disorder.

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