Mereo setrusumab Phase 3 trials miss primary fracture endpoints; BMD improvements seen

Mereo BioPharma Group plc

Neither ORBIT (placebo) nor COSMIC (bisphosphonate) achieved statistical significance on annualized clinical fracture rate.
Both studies met secondary endpoint of bone mineral density (BMD) improvements with strong statistical significance.
Cash balance $48.7M at Q3 2025; company reducing pre-commercial and manufacturing costs.
Additional analyses underway; management cites low placebo fracture rate in ORBIT.
Continued partnering discussions for alvelestat; pipeline programs with partners remain.

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