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STAT·Apr 24·1 min read
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FDA to fast-track review of three psychedelic therapies for depression and PTSD

Apr 24, 2026·read at STAT ↗RegulatoryPositive

The FDA announced it will accelerate the review of psychedelic drugs from three companies as part of a broader initiative to increase access to mental-health treatments.

Compass Pathways will receive a priority review voucher for its psilocybin candidate aimed at treatment-resistant depression. Usona Institute's similar psilocybin product for major depressive disorder also qualifies for the voucher.

Transcend Therapeutics will get a voucher for its MDMA-like therapy targeting post-traumatic stress disorder. The accelerated timelines are intended to bring these experimental therapies to patients more quickly.

The move reflects the current administration's emphasis on expanding options for mental-health care, though the drugs remain under investigation and have not yet received approval.

source

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

Original headline: “STAT+: FDA to speed up review of three psychedelics as mental health treatments”

read at STAT ↗
564 words · retrieved Apr 26
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companies & drugs in this story

companies
COMPASS Pathways plc2LEADING2Sanofi2Sanofi2Transcend Therapeutics Inc2
drugs
(aeruginascin + baeocystin + psilocybin)3MYCO-0033Oral Psilocybin3Psilocybin (Microneedle Patch)3psilocybin3cannabis
topics
Major Depression4Psychiatry & CNS4Approval

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