Mereo BioPharma gives Q3 2026 update on setrusumab and alvelestat regulatory talks

Mereo BioPharma Group plc reported third quarter 2026 results on November 9, 2026, with updates on its two lead programs. Following the Orbit and Cosmic Phase 3 studies of setrusumab in osteogenesis imperfecta, reported in December 2025, Mereo and its partner Ultragenyx Pharmaceutical have been in discussions with regulators to assess what data would be needed to support a filing and whether a path forward exists.¹ At the October 2026 ASBMR Annual Meeting, pre- and post-hoc analyses from both studies were presented, including baseline characteristics and annual fracture rate analyses in patient subgroups; in patients with at least 3 fractures in the prior 2 years, the analyses showed a benefit on fractures, bone mineral density and other endpoints in both Phase 3 studies.¹

For alvelestat in alpha-1 antitrypsin deficiency-associated lung disease, Mereo's August agreement with Sentynl Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Limited, gave Sentynl the option to acquire U.S. commercial and global manufacturing rights.¹ If Sentynl exercises that option during the short option period, Mereo would receive $40 million in upfront and R&D payments, be eligible for up to $435 million in milestones plus tiered royalties, and would lead the global Phase 3 study and regulatory interactions until completion.¹ The companies have been working to streamline the Phase 3 design, and Mereo has been preparing to start the study in early 2027.¹ Mereo said it expects to provide an update before the end of the year based on ongoing FDA interactions.¹

On vantictumab for ADO2, partner āshibio presented legacy biomarker data at ASBMR and said it intends to begin clinical trials in ADO2 patients in the first half of 2028.¹

Mereo had cash and cash equivalents of $26.1 million as of September 30, 2026, down from $41.0 million at December 31, 2025, which the company said should fund committed trials and operations into late 2027.¹