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.
- Drug:
- CCX0722
- Announced Date:
- February 11, 2025
- Indication:
- Weight Management Solution
Announcement
Cosmos Health Inc. announced that Clinical trials expected to complete in late 2025 or early 2026
AI Summary
Cosmos Health Inc. announced that its innovative weight management solution, CCX0722, is in the final stages of development. The company is currently finalizing its scale-up production phase while working with Contract Research Organizations to complete the technical dossier. Importantly, clinical trials for CCX0722 are expected to finish in late 2025 or early 2026. This milestone is a critical step toward regulatory submission and the potential classification of the device as a Class III medical device. With the clinical trials nearing their completion, Cosmos Health is positioning CCX0722 for a market launch projected in the first or second quarter of 2026. Further updates on the progress of the product and regulatory pathway will be provided in the coming months, marking an important phase in the development of this promising weight management program.
Read Announcement- Drug:
- CCX0722
- Announced Date:
- February 11, 2025
- Indication:
- Weight Management Solution
Announcement
Cosmos Health Inc. announced that Product launch expected in the first or second quarter of 2026
AI Summary
Cosmos Health Inc. has announced progress on its innovative weight management solution, CCX0722, with key development milestones in place. The company is finalizing the scale-up production phase and working with Contract Research Organizations to complete its technical dossier. Clinical trials are expected to finish between late 2025 and early 2026, paving the way for the product’s regulatory submission and potential classification as a Class III medical device. A significant highlight of the announcement is the anticipated product launch, which is scheduled for the first or second quarter of 2026. This timeline indicates that Cosmos Health is on track to introduce CCX0722 to the market, emphasizing its commitment to safety and efficacy. The company plans to provide further updates on its progress in the coming months as it moves closer to delivering this innovative solution.
Read Announcement- Drug:
- CCX0722
- Announced Date:
- February 11, 2025
- Indication:
- Weight Management Solution
Announcement
Cosmos Health Inc. announced that it is entering the final stage of development for CCX0722, its innovative weight management solution.
AI Summary
Cosmos Health Inc. announced that its innovative weight management solution, CCX0722, is entering the final stage of development. The company is finalizing its scale-up production phase while collaborating with Contract Research Organizations to complete the necessary technical dossier. These efforts are key to preparing for human clinical trials, which are expected to conclude between late 2025 and early 2026. CCX0722 is anticipated to be potentially classified as a Class III medical device, underscoring its advanced design and safety features.
With a projected market launch in the first or second quarter of 2026, Cosmos Health is steadily advancing toward regulatory submission. This milestone highlights the company’s commitment to providing a science-backed solution for weight management, addressing critical challenges related to obesity. Further updates on CCX0722’s progress will be shared in the coming months.
Read Announcement
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 "Clinical Trial," with the company reporting: "Cosmos Health Inc. announced that Clinical trials expected to complete in late 2025 or early 2026"
Currently, Cosmos Health has one therapy (CCX0722) targeting the following condition: Weight Management Solution.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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 7/12/2025 by MarketBeat.com Staff
