Ipsen has reported the failure of its pivotal phase II FALKON trial, which evaluated its investigational drug fidrisertib in patients with the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP).
The trial did not meet its primary endpoint, namely the reduction of abnormal new bone formation volume in adults and children with FOP compared to placebo, resulting in the closure of the study.
However, Ipsen notes that fidrisertib was generally well tolerated, with no safety concerns observed during the trial, and that "the data obtained will contribute to the growing body of research on FOP."
A genetic disease characterized by the formation of bone in soft and connective tissues, FOP shortens life expectancy to a median age of 56 years and has a prevalence of approximately 1.36 per million individuals worldwide.
Ipsen specialises in the research, development, manufacture and marketing of specialty medicines. Net sales by therapeutic area break down as follows:
- oncology (69.2%);
- neuroscience (20.3%);
- rare diseases (10.5%).
At the end of 2025, the group had 7 research and development centers located in France (2), the United Kingdom (2), China (2) and Ireland, and 5 manufacturing sites worldwide.
Net sales are distributed geographically as follows: France (8%), Europe (31.7%), the United States (32.9%), North America (2.2%) and other (25.2%).
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