secwatch.observer — SEC 8-K summary ====================================== Issuer: Mereo BioPharma Group plc (MREO) CIK: 0001719714 Form: 8-K Filed at: 2025-07-10T23:59:59+00:00 Accession: 0000950170-25-094921 Event type: other_material Sentiment: positive Materiality: 0.70 Item codes: 8.01 LLM model: deepseek-v4-flash:cloud Mereo BioPharma and Ultragenyx Provide Update on Phase 3 Orbit and Cosmic Studies of UX143 in Osteogenesis Imperfecta -------------------------------------------------------------------------------- - The Phase 3 Orbit study final analysis is expected around end of 2025, with a threshold of p<0.04. - DMC informed Ultragenyx that UX143 has an acceptable safety profile and study should continue to final analysis. - Safety in the younger patient population (Cosmic study) is consistent with other studies; no interim analysis of Cosmic data. - Final analyses will occur after patients have been on therapy for at least 18 months; threshold for Cosmic is p<0.05. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1719714/000095017025094921/0000950170-25-094921-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1719714/000095017025094921/mreo-20250709.htm HTML page: https://secwatch.observer/filing/0000950170-25-094921 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer