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
Alvelestat, Vantictumab, and setrusumab. 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.
Alvelestat (AATD) FDA Regulatory Events
Alvelestat (AATD) is a drug developed by Mereo BioPharma Group for the following indication: Alpha-1 Antitrypsin Deficiency (AATD) associated Emphysema.
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:
- Alvelestat (AATD)
- Announced Date:
- January 12, 2026
- Indication:
- Alpha-1 Antitrypsin Deficiency (AATD) associated Emphysema
Announcement
Mereo BioPharma Group plc today provided an update on its programs, setrusumab for the treatment of osteogenesis imperfecta (OI) and alvelestat, which is being studied for the treatment of alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), and revised its cash runway guidance.
AI Summary
Mereo BioPharma reported updates on its two lead programs—setrusumab for osteogenesis imperfecta (OI) and alvelestat for alpha-1 antitrypsin deficiency‑associated lung disease (AATD‑LD)—and revised its cash runway. The company said Phase 3 data from the Orbit and Cosmic studies, including bone mineral density (BMD), vertebral fractures, and patient‑reported pain and function, will be presented at the J.P. Morgan Healthcare Conference. Additional analyses of those trials are ongoing to decide the program’s path forward.
The Phase 3 studies did not meet their primary fracture endpoints but showed strong, statistically significant improvements in BMD as a key secondary measure, with a safety profile consistent with prior studies. Mereo has reduced and delayed some pre‑commercial and manufacturing activities while it and partner Ultragenyx assess next steps.
Mereo is advancing plans for a single global Phase 3 of alvelestat—about 220 patients over 18 months—with SGRQ and CT lung density as key endpoints and is in partner discussions. Cash and cash equivalents were approximately $41 million at December 31, 2025, funding operations to mid‑2027.
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Vantictumab FDA Regulatory Events
Vantictumab is a drug developed by Mereo BioPharma Group for the following indication: for Autosomal Dominant Osteopetrosis Type 2.
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:
- Vantictumab
- Announced Date:
- August 19, 2025
- Indication:
- for Autosomal Dominant Osteopetrosis Type 2
Announcement
āshibio, a privately held, clinical-stage biotechnology company developing novel therapeutics for the treatment of bone and connective tissue disorders, today announced an exclusive licensing agreement with Mereo BioPharma for vantictumab for the treatment of autosomal dominant osteopetrosis type 2 (ADO2), a rare, debilitating bone disorder with no approved therapies.
AI Summary
āshibio, a privately held clinical-stage biotechnology company focused on bone and connective tissue disorders, announced an exclusive global (excluding Europe) license from Mereo BioPharma for vantictumab to treat autosomal dominant osteopetrosis type 2 (ADO2), a rare, debilitating disease with no approved therapies. This marks the second clinical-stage asset āshibio has licensed from Mereo, following promising insights in a mouse model of osteopetrosis.
ADO2, also called Albers-Schönberg disease, results from a CLCN7 gene mutation that impairs osteoclasts, causing overly dense but brittle bones, frequent fractures, poor healing, low blood counts and nerve pain. Vantictumab, a monoclonal antibody that blocks key Wnt signaling receptors, was previously tested in oncology trials and showed a favorable safety profile and biomarker evidence of osteoclast activity.
Under the agreement, āshibio will lead clinical development and commercialization outside Europe, aiming to rapidly advance vantictumab into human studies for both adult and pediatric ADO2 patients.
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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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