Mereo BioPharma Group's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Mereo BioPharma Group (MREO).
Over the past two years, Mereo BioPharma Group has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
setrusumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Setrusumab FDA Regulatory Events
Setrusumab is a drug developed by Mereo BioPharma Group for the following indication: For the treatment of Osteogenesis Imperfecta.
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:
- setrusumab
- Announced Date:
- January 12, 2025
- Indication:
- For the treatment of Osteogenesis Imperfecta
Announcement
Mereo BioPharma Group plc today provided an update on its lead clinical programs, setrusumab, a monoclonal antibody in Phase 3 clinical development for the treatment of Osteogenesis Imperfecta (OI) through a partnership with Ultragenyx Pharmaceutical, Inc.
AI Summary
Mereo BioPharma Group plc provided an update on its lead clinical programs focused on rare diseases. The update highlighted setrusumab, a monoclonal antibody being developed in Phase 3 for treating Osteogenesis Imperfecta (OI). This program is advancing through a partnership with Ultragenyx Pharmaceutical, Inc. The ongoing Phase 3 Orbit Study is dosing patients and is on track for a planned second interim analysis in mid-2025. In addition, the Cosmic study, an open-label trial comparing setrusumab against standard intravenous bisphosphonate therapy in young patients aged 2 to under 7 years, is also continuing treatment. The promising data from earlier Phase 2 studies have built strong confidence in setrusumab’s potential to become a standard-of-care treatment for OI. The company is actively preparing for market launch in key European regions while moving forward with these critical clinical milestones.
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Mereo BioPharma Group FDA Events - Frequently Asked Questions
As of now, Mereo BioPharma Group (MREO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Mereo BioPharma Group (MREO) has reported FDA regulatory activity for setrusumab.
The most recent FDA-related event for Mereo BioPharma Group occurred on January 12, 2025, involving setrusumab. The update was categorized as "Provided Update," with the company reporting: "Mereo BioPharma Group plc today provided an update on its lead clinical programs, setrusumab, a monoclonal antibody in Phase 3 clinical development for the treatment of Osteogenesis Imperfecta (OI) through a partnership with Ultragenyx Pharmaceutical, Inc."
Currently, Mereo BioPharma Group has one therapy (setrusumab) targeting the following condition: For the treatment of Osteogenesis Imperfecta.
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:MREO) was last updated on 8/2/2025 by MarketBeat.com Staff
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