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COMPASS Pathways (CMPS) FDA Events

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COMPASS Pathways' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by COMPASS Pathways (CMPS). Over the past two years, COMPASS Pathways has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as COMP004, COMP005, COMP360, and XOLREMDI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

COMP004 FDA Regulatory Events

COMP004 is a drug developed by COMPASS Pathways for the following indication: For Treatment-Resistant Depression. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

COMP005 FDA Regulatory Events

COMP005 is a drug developed by COMPASS Pathways for the following indication: for treatment resistant depression (TRD). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

COMP360 FDA Regulatory Timeline and Events

COMP360 is a drug developed by COMPASS Pathways for the following indication: for treatment resistant depression (TRD). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

XOLREMDI FDA Regulatory Events

XOLREMDI is a drug developed by COMPASS Pathways for the following indication: for treatment-resistant depression. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

COMPASS Pathways FDA Events - Frequently Asked Questions

In the past two years, COMPASS Pathways (CMPS) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, COMPASS Pathways (CMPS) has reported FDA regulatory activity for the following drugs: COMP360, COMP005, COMP004 and XOLREMDI.

The most recent FDA-related event for COMPASS Pathways occurred on May 14, 2025, involving COMP360. The update was categorized as "Provided Update," with the company reporting: "Compass Pathways plc that management will participate in a fireside chat at the 2025 RBC Capital Markets Global Healthcare Conference at 10:30 am ET on May 20th, 2025."

Current therapies from COMPASS Pathways in review with the FDA target conditions such as:

  • for treatment resistant depression (TRD). - COMP360
  • for treatment resistant depression (TRD). - COMP005
  • For Treatment-Resistant Depression - COMP004
  • for treatment-resistant depression - XOLREMDI

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:CMPS) was last updated on 7/22/2025 by MarketBeat.com Staff
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