Kyowa Kirin Announces Positive Phase 3 Results for Infigratinib in Achondroplasia

Reuters02-16

Kyowa Kirin Announces Positive Phase 3 Results for Infigratinib in Achondroplasia

Kyowa Kirin Co. Ltd. announced positive topline results from the global Phase 3 PROPEL 3 study of infigratinib (KK8398), an oral FGFR1-3 inhibitor, in children with achondroplasia aged 3 to less than 18 years with open growth plates. The pivotal, randomized, placebo-controlled study, conducted globally excluding Japan, achieved its primary endpoint, demonstrating high efficacy and favorable tolerability. BridgeBio Pharma, Kyowa Kirin’s development partner, plans to discuss regulatory submissions for approval in the U.S. and EU in the second half of 2026. Additional results are scheduled to be presented at future medical conferences. In Japan, Kyowa Kirin has initiated the AOBA Phase 3 clinical trial of infigratinib to assess its efficacy and safety in Japanese patients with achondroplasia.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Kyowa Kirin Co. Ltd. published the original content used to generate this news brief on February 16, 2026, and is solely responsible for the information contained therein.

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