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STAT·4h ago·1 min read
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Compass Pathways CEO says company will proceed cautiously as it readies psychedelic therapy for FDA review

Oct 15, 2026·read at STAT ↗RegulatoryNeutral

Compass Pathways chief executive Kabir Nath told reporters at the STAT Summit that the company will "go slow before we go fast," emphasizing that early negative experiences could hurt the emerging psychedelics sector.

The firm is completing a rolling submission to the U.S. Food and Drug Administration this quarter for COMP360, a synthetic psilocybin product intended for patients with treatment-resistant depression, with a target launch early next year.

Nath said any approval would likely come with an FDA risk evaluation and mitigation strategy, and he believes the therapy could be a significant development for patients, providers, and the company itself.

source

This writeup was produced by pharmadog from original reporting by STAT.

Original headline: “Compass Pathways CEO: Psychedelics company will ‘go slow before we go fast’”

read at STAT ↗
1,024 words · retrieved 2h ago
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companies & drugs in this story

companies
COMPASS Pathways plc6JOHNSON & JOHNSONLife Biosciences Inc.NEUROCRINENEUROCRINE BIOSCIENCES INCROCHEUltragenyx Pharmaceutical Inc.
drugs
(aeruginascin + baeocystin + psilocybin)3MYCO-0033Oral Psilocybin3Psilocybin (Microneedle Patch)3psilocybin3esketamine hydrochloride2Rare DiseaseSRX-25cannabisesketamine
topics
Major Depression5Approval3Psychiatry & CNS3AdComImmunologyRare Disease

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