BridgeBio Pharma announced that positive results from the PROPEL 3 trial of oral infigratinib for children with achondroplasia were published in the New England Journal of Medicine. The data, presented at the International Congress of Children’s Bone Health (ICCBH) 2026, showed a statistically significant improvement in annualized height velocity (AHV) compared to placebo. The company intends to submit a New Drug Application (NDA) to the FDA in the third quarter of 2026, with a U.S. launch anticipated in early to mid 2027.

The Phase 3 PROPEL 3 study successfully met its primary endpoint of change from baseline in AHV, with a least squares (LS) mean treatment difference of +1.74 cm/year (p<0.0001). The observed mean difference was +2.10 cm/year (p<0.0001), marking the largest mean increase reported in any Phase 3 achondroplasia study. Additionally, the trial met the key secondary endpoint of change from baseline in height Z-score at Week 52 (p<0.0001), with an LS mean increase of +0.41 SD on the treatment arm.

Key Efficacy and Safety Findings

In a pre-specified exploratory analysis, oral infigratinib demonstrated the first statistically significant improvement in body proportionality in a Phase 3 achondroplasia study. The LS mean treatment difference was –0.05 (p<0.05) in children younger than 8 years old. New data presented at ICCBH also showed a statistically significant improvement in arm span Z-score versus placebo (LS mean +0.37 SD; p<0.0001), the first such result reported for an achondroplasia trial at 52 weeks.

Oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to the study drug. Safety data indicated no adverse events associated with inhibition of FGFR1 or FGFR2. There were 3 cases (4%) of hyperphosphatemia, all mild, transient, asymptomatic, and not requiring dose reductions or discontinuations.

Regulatory Status and Future Plans

BridgeBio plans to submit an NDA to the FDA in the third quarter of 2026 and a Marketing Authorization Application (MAA) to the EMA in the second half of 2026. Oral infigratinib has received Breakthrough Therapy Designation, Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the FDA for achondroplasia. If approved, the company may qualify for a Priority Review Voucher.

BridgeBio Pharma, Inc. granted 66,810 restricted stock units to 30 new employees as an inducement for entering into employment with the company. The compensation committee of BridgeBio’s board of directors approved the equity grants on June 18, 2026, in accordance with Nasdaq Listing Rule 5635(c)(4). The awards were issued pursuant to the terms of the company’s equity incentive plan, which was originally adopted in November 2019 and subsequently amended and restated on February 10, 2023, and December 13, 2023.

Vesting Schedule

The vesting of the restricted stock units is structured to encourage long-term retention. One-fourth of the shares underlying each employee’s restricted stock units will vest on May 16, 2027. The remaining shares will vest on a quarterly basis thereafter, with one-twelfth of the remaining shares vesting each quarter. All vesting is contingent upon the employee’s continued employment with BridgeBio or one of its subsidiaries on the applicable vesting dates.

Grant Details