Announcement • Sep 09

BridgeBio Pharma, Inc. Announces Results From Phase 3 PROPEL 3 Trial Of Oral Infigratinib In Children With Achondroplasia

BridgeBio Pharma, Inc. reported that treatment with oral infigratinib for 52 weeks in PROPEL 3 resulted in favorable trends against placebo in clinically meaningful exploratory endpoints including sleep apnea and otitis media events. Stabilization of sleep apnea measures: The mean total Apnea-Hypopnea Index (AHI) at 52 weeks remained consistent with the baseline mean in the oral infigratinib group, with a 10.4% increase, versus a 49.2% increase in the placebo group; in children younger than 8 years of age, the mean total AHI was unchanged for the oral infigratinib group, versus a 63.2% increase in the placebo group. Reduction in rate of ear infections: The estimated annualized rate of otitis media events was 38% lower in the oral infigratinib group compared to the placebo group; in children younger than 8 years of age, the annualized rate of otitis media events was 47% lower in the oral infigratinib group compared to the placebo group. In children treated for up to three years in the PROPEL program, oral infigratinib demonstrated sustained improvements in growth (CFBL in height Z-score of +0.92 SD at Year 3) and body proportionality (CFBL in upper-to-lower body segment ratio of -0.15 at Year 3), with a well-tolerated safety profile and no new safety signals. These findings build on the previously reported PROPEL 3 primary and secondary endpoint results published in NEJM, in which oral infigratinib demonstrated a +2.10 cm/year improvement in AHV versus placebo (p2), with a greater increase in lean body mass (1.77 versus 1.58 kg) and smaller increases in body fat mass (0.95 versus 1.12 kg) and visceral fat volume (1.55 versus 18.42 mL) compared to placebo. In addition to the late-breaking oral presentation at the Annual ESPE Meeting 2026, BridgeBio shared a poster, Longer-Term Efficacy and Safety Results of Infigratinib in Children with Achondroplasia, presented by Dr. Irving. These findings showed that in children treated for up to three years in the PROPEL program, oral infigratinib demonstrated sustained improvements in growth, with a change from baseline in height Z-score relative to the achondroplasia population of +0.92 SD at Year 3. Additionally, oral infigratinib demonstrated sustained improvements in proportionality, with a change from baseline in upper-to-lower body segment ratio of -0.15 at Year 3. Results showed that oral infigratinib continued to be well-tolerated, with no new safety signals identified. BridgeBio also shared one poster focused on PROPEL Infant & Toddler (I&T), an ongoing Phase 2/2b study in children under 3 years old with achondroplasia and one eposter focused on qualitative research on the impacts of hypochondroplasia. PROPEL 3 demonstrated best-in-class improvements in annualized height velocity (AHV) and, for the first time in a Phase 3 achondroplasia study, statistically significant improvements in body proportionality and arm span, supporting its potential as the first oral targeted therapeutic option that directly impacts FGFR3. The topline results can be found here [1]. These data were published as an original research article in the New England Journal of Medicine (NEJM) and simultaneously presented at the International Congress of Children’s Bone Health (ICCBH) 2026 in a late-breaking oral presentation. BridgeBio submitted an NDA to the FDA for oral infigratinib in achondroplasia and anticipates a U.S. launch in mid-2027. The Company intends to submit a Marketing Authorization Application (MAA) for achondroplasia to the European Medicines Agency in the fourth quarter of 2026. Oral infigratinib has received Breakthrough Therapy Designation from the U.S. FDA based on the shared results from the PROPEL 2 clinical trial, which meet the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoints. In addition to receipt of Breakthrough Therapy Designation, oral infigratinib has also received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation for achondroplasia from the FDA. If oral infigratinib is approved, BridgeBio may qualify for a Priority Review Voucher. Information about PROPEL I&T trial (NCT07169279) can be found here [3] on clinicaltrials.gov [4]. Information about ACCEL, the Company’s observational lead-in study for oral infigratinib in hypochondroplasia’s Phase 3 study (NCT06410976) can be found here [5], and information about ACCEL 2/3, BridgeBio’s Phase 2/3 clinical study of oral infigratinib in hypochondroplasia (NCT06873035) can be found here [6].

Announcement • Sep 02

BridgeBio Pharma, Inc. Presents New Data On The Impact Of Oral Infigratinib On Medical Complications In Achondroplasia At The Annual ESPE Meeting 2026

BridgeBio Pharma, Inc. announced that one late-breaking oral presentation on the impact of oral infigratinib on medical complications in achondroplasia from PROPEL 3 will be shared at the Annual European Society for Paediatric Endocrinology (ESPE) Meeting 2026, taking place in Marseille, France on September 8-10, 2026. In addition to the late-breaking oral presentation, two posters and one eposter will be shared on longer-term data for oral infigratinib in achondroplasia, PROPEL I&T–an ongoing Phase 2/2b study in children under 3 years old with achondroplasia, and qualitative research on the impacts of hypochondroplasia. BridgeBio is committed to exploring the potential of oral infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasia conditions, which hold significant unmet needs for families. Late-Breaking Oral Presentation: A Randomized Controlled Trial of Oral Infigratinib in Children with Achondroplasia: Results from the PROPEL 3 Study. Posters: Longer-Term Efficacy and Safety Results of Infigratinib in Children with Achondroplasia. PROPEL Infant and Toddler: Study Design and Ongoing Enrollment of a Phase 2/2b Study of Infigratinib in Children under 3 Years Old with Achondroplasia. ePoster: Potential Medical Challenges and Functional Impacts of Hypochondroplasia: Qualitative Interviews with Children and Parents. Achondroplasia is the most common cause of disproportionate short stature, affecting approximately 55,000 people in the U.S. and European Union (EU), including up to 10,000 children and adolescents with open growth plates. Achondroplasia impacts overall health and quality of life, leading to medical complications such as obstructive sleep apnea, middle ear dysfunction, kyphosis, and spinal stenosis. The condition is uniformly caused by an activating variant in FGFR3. Oral infigratinib is an investigational small molecule designed to inhibit FGFR3 signaling and target skeletal dysplasias, including achondroplasia and hypochondroplasia, at their source. Overactivating FGFR3 pathogenic variants drive downstream MAPK and STAT1 signaling that aberrates growth plate development, thereby causing disproportionate short stature and the potential for serious health complications. Oral infigratinib improves bone growth by decreasing the overactivity of FGFR3.

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BridgeBio Pharma, Inc. Announces Results From Phase 3 PROPEL 3 Trial Of Oral Infigratinib In Children With Achondroplasia

BridgeBio Pharma, Inc. Presents New Data On The Impact Of Oral Infigratinib On Medical Complications In Achondroplasia At The Annual ESPE Meeting 2026

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