Mereo BioPharma's UX143 Phase 3 Study Progresses as Planned, Reaches Final Analysis by Year-End.

Mereo BioPharma's (MREO) UX143 Phase 3 Orbit study is advancing as planned, with the Data Monitoring Committee confirming an acceptable safety profile. The trial aims to assess UX143 in pediatric and young adult patients with osteogenesis imperfecta. Analysts forecast an average target price of $7.30, indicating an upside of 148.21% from the current price of $2.94, based on one-year price targets from 6 analysts.

NOVATO, Calif., July 02, 2025 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma Group plc (NASDAQ: MREO) announced that the randomized, placebo-controlled Phase 3 portion of the Orbit study evaluating UX143 (setrusumab) in pediatric and young adult patients with osteogenesis imperfecta (OI) is progressing as planned. The Data Monitoring Committee (DMC) met and confirmed that UX143 demonstrates an acceptable safety profile, allowing the study to continue to the final analysis. The final analyses for both the Orbit and Cosmic studies are expected around the end of the year [1].

Emil D. Kakkis, M.D., Ph.D., chief executive officer and president of Ultragenyx, stated, "Based on the feedback we hear from investigators and families who participated in the studies, we are confident that increasing bone mass leads to stronger bone, less fractures, and improved physical abilities. While we had hoped to be able to stop the study early, we look forward to having results from both Orbit and Cosmic around the end of this year."

The Orbit study is evaluating the effect of setrusumab on clinical fracture rate in patients aged 5 to 25 years, while the Cosmic study is assessing the drug's efficacy in reducing the annualized fracture rate in patients aged 2 to 7 years. Both studies are part of a comprehensive late-stage program to develop setrusumab for OI across different sub-types [1].

Analysts are forecasting an average target price of $7.30 for Mereo BioPharma (MREO), indicating an upside of 148.21% from the current price of $2.94, based on one-year price targets from 6 analysts. This reflects the potential impact of positive clinical trial results and the growing interest in rare disease treatments [1].

References:
[1] https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-and-mereo-biopharma-announce-ux143-phase-3-orbit