Ipsen update on Phase II FALKON trial in patients with ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP)
IPSEN SA S/ADR (IPSEY)
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Source: GlobeNewswire
PARIS, FRANCE, 19 December 2025 - Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the pivotal Phase II FALKON trial did not meet its primary endpoint of reducing new heterotopic ossification (HO) in adults and children living with fibrodysplasia ossificans progressiva (FOP) vs. placebo, as a result the study will be closed. The investigational medicinal product (fidrisertib) was generally well tolerated, with no safety concerns in the trial. “These results are disappointing for the FOP community and patients living with this devastating disease,” said Christelle Huguet, PhD, EVP, Head of Research and Development. “However, we do believe that these data will contribute to the growing body of research on FOP, giving new insights into managing this disease for patients and their care providers. FALKON was a tremendous undertaking by Ipsen, continuing our commitment to FOP. FALKON enrolled 113 patients globally, taking over 5 years to reach this critical milestone. We would like t
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