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Cosmos Health (COSM) FDA Events

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FDA Events for Cosmos Health (COSM)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Cosmos Health (COSM). Over the past two years, Cosmos Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CCX0722. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

CCX0722 - FDA Regulatory Timeline and Events

CCX0722 is a drug developed by Cosmos Health for the following indication: Weight Management Solution. 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.

Cosmos Health FDA Events - Frequently Asked Questions

As of now, Cosmos Health (COSM) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Cosmos Health (COSM) has reported FDA regulatory activity for CCX0722.

The most recent FDA-related event for Cosmos Health occurred on February 11, 2025, involving CCX0722. The update was categorized as "Provided Update," with the company reporting: "Cosmos Health Inc. announced that it is entering the final stage of development for CCX0722, its innovative weight management solution."

Currently, Cosmos Health has one therapy (CCX0722) targeting the following condition: Weight Management Solution.

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:COSM) was last updated on 7/11/2025 by MarketBeat.com Staff
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