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Key Dates and Disclosure Events Shareholders Need to Know
NEW YORK, March 4, 2026 /PRNewswire/ -- June 5, 2023: Phase 2 data announced showing BMD improvements. July 6, 2023: First patients dosed in Phase 3 trials. April 30, 2024: Full enrollment completed. July 9, 2025: Second interim analysis fails. December 29, 2025: Both Phase 3 trials fail. Between these dates, Mereo BioPharma Group plc (NASDAQ: MREO) shareholders allege they were kept in the dark about fundamental challenges facing the setrusumab program.
Contact us if you suffered losses or reach Joseph E. Levi, Esq. at jlevi@levikorsinsky.com | (212) 363-7500.
Chronology of Material Events
June 5, 2023 — Phase 2 Portion Data Released
The complaint recounts that Mereo announced positive data from the Phase 2 portion of the ORBIT study, reporting "statistically significant increases" in bone formation markers and "substantial and significant improvement in bone mineral density." The lawsuit chronicles that this announcement set investor expectations for the Phase 3 trials.
July 6, 2023 — First Phase 3 Patients Dosed
As detailed in the action, Ultragenyx's Chief Medical Officer stated the Phase 3 program was "designed to study the impact of setrusumab on clinical fracture risk reduction." The complaint notes the two Phase 3 trials—ORBIT and COSMIC—targeted different age ranges of OI patients.
Timeline of Alleged Disclosure Failures
July 9, 2025 — The Interim Analysis Disclosure
The lawsuit chronicles that despite the interim failure, defendants continued to express optimism. Ultragenyx CEO Emil Kakkis allegedly stated: "we are confident that increasing bone mass leads to stronger bone, less fractures, and improved physical abilities." The complaint contends this statement perpetuated the alleged misrepresentations.
"Timely disclosure of material developments is fundamental to fair and efficient markets," stated Joseph E. Levi, Esq. "We encourage shareholders to learn about their rights under the federal securities laws."
ABOUT THE FIRM
For over two decades, Levi & Korsinsky, LLP has represented shareholders in securities class actions. The firm has ranked in ISS Securities Class Action Services' Top 50 Report for seven consecutive years. Those wishing to serve as lead plaintiff must act by April 6, 2026.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
(212) 363-7500
jlevi@levikorsinsky.com
www.zlk.com
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SOURCE Levi & Korsinsky, LLP
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