Kyowa Kirin Highlights Upcoming Presentation of Phase 3 PROPEL 3 Results for Oral Infigratinib in Achondroplasia at ICCBH 2026 - BridgeBio reported new findings following the achievement of the primary endpoint -
June 24, 2026
Tokyo, Japan, June 24, 2026 -- Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Abdul Mullick, “Kyowa Kirin”) today announced that its development partner BridgeBio Pharma, Inc. (hereinafter “BridgeBio”) will present additional data from PROPEL 3, a global Phase 3 pivotal study of oral infigratinib for children living with achondroplasia, as a Late-Breaking Oral Presentation at the International Congress of Children’s Bone Health (ICCBH) 2026, to be held in Montreal, Canada from June 27–30, 2026. ICCBH is an international conference focusing on research in bone metabolism and bone mass in children and young individuals, and is widely recognized globally as a leading scientific meeting in this field. It is generally held every two years.
PROPEL 3 is a global pivotal study evaluating the efficacy and safety of oral infigratinib in children with achondroplasia. Previously disclosed topline results demonstrated that the study met its primary endpoint and suggested the potential of infigratinib as an oral treatment option.
In addition to the PROPEL 3 presentation, BridgeBio plans to present multiple abstracts at the meeting, including research on quality of life, early intervention, and observational study findings in achondroplasia, as well as educational initiatives for children and their families.
- Late-Breaking Oral Presentation:
A Randomized Controlled Trial of Oral Infigratinib in Children with Achondroplasia -
- Presenter: Ravi Savarirayan, M.D., Ph.D. of Murdoch Children’s Research Institute, Melbourne, AU, and Global Lead Investigator for PROPEL 3
- Date & Time: Sunday, June 28 at 3:45 pm EDT
- Oral Presentation:
Health-Related Quality of Life in Children with Achondroplasia: Findings from the Observational PROPEL Study -
- Presenter: Marie-Eve Robinson, M.D., M. Sc., Shriners Hospital for Children Canada, McGill University, CA
- Date & Time: Monday, June 29 at 11:00 am EDT
- Posters:
A Phase 2/2b Study of Infigratinib in Children Under 3 Years Old with Achondroplasia: Design of PROPEL Infant and Toddler -
- Presenter: Julie Hoover-Fong, M.D., Ph.D., Johns Hopkins University, U.S.
- Date & Time: Sunday, June 28 at 12:00 pm EDT
- The ACCEL Observational Study: Diagnostic Features, Medical History, and Baseline Characteristics of Children with Hypochondroplasia
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- Presenter: Marie-Eve Robinson, M.D., M. Sc., Shriners Hospital for Children Canada, McGill University, CA
- Date & Time: Monday, June 29 at 12:00 pm EDT
- MyAchonJourney: An Online Educational Resource for Individuals with Achondroplasia and Their Families, Developed by Advocacy Leaders and Healthcare Providers
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- Presenter: Kirsten Kiefer, BridgeBio Skeletal Dysplasias, U.S.
- Date & Time: Monday, June 29 at 12:00 pm EDT
- Qualitative Research to Evaluate the Content Validity and Relevance of Patient-Reported Outcome Measures for Children and Parents of Children with Hypochondroplasia
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- Presenter: Chandler Crews, The Chandler Project, U.S.
- Date & Time: Monday, June 29 at 12:00 pm EDT
Under the collaboration with BridgeBio, Kyowa Kirin holds the exclusive rights for the development and commercialization of infigratinib in skeletal dysplasias in Japan. In November 2025, Kyowa Kirin initiated a Phase 3 clinical study (AOBA study; jRCT2031240562) in Japanese children with achondroplasia to evaluate the efficacy and safety of infigratinib in the Japanese population and aims to establish a new oral treatment option that is not currently available in Japan.
Kyowa Kirin is committed to addressing unmet medical needs in rare diseases, including skeletal dysplasias, and will continue to advance the development of infigratinib with the aim of delivering a new treatment option for people living with achondroplasia in Japan.
- About KK8398 (Infigratinib)
- KK8398 (infigratinib) is a selective, oral small-molecule inhibitor of FGFR1–3. BridgeBio Pharma is currently conducting a global Phase 3 study for achondroplasia. In Japan, Kyowa Kirin holds exclusive licensing rights for the development and commercialization of KK8398 in skeletal dysplasias.
- About Achondroplasia
- Achondroplasia, a representative genetic condition characterized by short stature, occurs in approximately 1 in 20,000 live births and affects about 55,000 individuals in the US and EU and approximately 6,000 in Japan. It is associated with a range of health and quality-of-life challenges, including short stature, foramen magnum stenosis, ventricular enlargement, spinal canal stenosis, kyphosis, obstructive sleep apnea, respiratory issues, otitis media, hearing loss, dental irregularities, limb complications, and obesity. Over 97% of cases have activating mutations in FGFR3, and these activating mutations are thought to suppress chondrocyte differentiation, cartilage matrix production, and proliferation, thereby impairing endochondral ossification and leading to the development of achondroplasia.
- About Kyowa Kirin
- Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by a severe or rare disease. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions – Japan, Asia Pacific, North America, and EMEA/International. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/
