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Dive Brief:

• Compass Pathways said it will lay off 30% of its workforce, narrow its research focus and explore selling its digital technologies after pushing back the timeline for its lead medicine, a psychedelic treatment for depression.

• The company now plans to release topline data from a Phase 3 study known as COMP005 in the second quarter of next year after telling investors in August to expect the data in the fourth quarter of this year. Results from a second study, COMP006, will likely be announced in the second half of 2026; Compass previously targeted mid-2025 for top-line data from that study.

• All resources at the company will be focused on advancing the lead drug, a synthetic form of psilocybin, for treatment-resistant depression, CEO Kabir Nath said. The program, dubbed COMP360, “is our absolute priority,” Nath said in the company’s statement Thursday.

Dive Insight:

The delayed Phase 3 timeline follows the Food and Drug Administration’s decision in August to reject Lykos Therapeutics’ bid to market MDMA-assisted therapy for post-traumatic stress disorder. FDA advisers had previously questioned the trial data for the drug, focusing especially on the question of “functional unblinding.”

Typically, a clinical trial will split patients into groups, with some receiving the experimental medicine and others getting a placebo. In most cases, both the patients and researchers are “blinded” as to which drug is being administered, which in theory prevents any bias or placebo effect from interfering with the results.

But in the case of psychedelics, the associated changes to cognition and senses may clue patients in the treatment group in to the fact that they are receiving the experimental drug. That, in turn, results in functional unblinding that may affect the results.

For Lykos, the FDA rejection led to a 75% cut in staff and the departure of the company’s founder. But the agency’s decision may have a broader effect as well, putting a chill on what has been growing interest in developing psychedelics for mental health disorders.

Compass said it now plans to wait to release data from COMP006 until after the blinded portion of its study has been completed by all patients and the 26-week time point has passed due to “the increased regulatory scrutiny on functional unblinding.” It did not give details on the delay for COMP005 in its statement.

With a potential approval and revenue stream now further off, Compass said it’s slimming down staff, general and administrative functions and eliminating two senior management roles, for the chief communications officer and Matthew Owens, who serves as chief legal officer and general counsel. All preclinical work that doesn’t affect the COMP360 program will also be stopped.