BridgeBio Pharma, Inc.

BridgeBio Pharma announced positive results from its Phase 3 PROPEL 3 study of oral infigratinib for achondroplasia, published in The New England Journal of Medicine and presented at ICCBH. The data showed statistically significant improvements in annualized height velocity (+1.74 cm/yr), height Z-score (+0.41 SD), and body proportionality, with the drug being well-tolerated. The company plans to submit an NDA to the FDA in Q3 2026 and an MAA to the EMA in H2 2026, anticipating a U.S. launch in early to mid-2027.

BridgeBio Pharma, Inc. announced the results of its 2026 Annual Meeting of Stockholders. Shareholders elected three Class I directors, approved executive compensation on an advisory basis, and ratified Deloitte & Touche LLP as the independent auditor. Additionally, the amendment and restatement of the 2021 Stock Option and Incentive Plan was approved, increasing shares reserved for issuance by 2,000,000. Dr. Randal W. Scott also resigned from the Board of Directors, effective June 22, 2026, upon completion of his term.

BridgeBio Pharma announced that its compensation committee approved equity grants to 30 new employees. These grants include an aggregate of 66,810 restricted stock units of the company's common stock. The awards are structured to vest one-fourth on May 16, 2027, with the remainder vesting quarterly thereafter, subject to continued employment. These grants serve as an inducement for the new employees to join the company, in accordance with Nasdaq Listing Rule 5635(c)(4).

BridgeBio Pharma announced it will present additional positive data from its PROPEL 3 global Phase 3 pivotal study of oral infigratinib for children with achondroplasia at the International Congress of Children’s Bone Health (ICCBH) 2026. The company will also share an oral presentation and four posters covering quality of life, early intervention research, observational study findings, and educational resources for achondroplasia. Additionally, a poster on autosomal dominant hypocalcemia type 1 (ADH1) findings from its CLARIFY disease monitoring study will be presented.

BridgeBio Pharma announced that the FDA has accepted its New Drug Application (NDA) for BBP-418, a potential first-in-class therapy for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), for Priority Review. The FDA set a PDUFA target action date of November 27, 2026, and is not currently planning an advisory committee meeting. If approved, BBP-418 would be the first and only therapy for LGMD2I/R9, addressing a significant unmet medical need for approximately 7,000 individuals in the U.S. and Europe. The drug previously met all primary and secondary endpoints in its Phase 3 FORTIFY trial.

BridgeBio Pharma announced the FDA has accepted its New Drug Application for oral BBP-418, granting it Priority Review for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). The FDA set a PDUFA target action date of November 27, 2026, and is not currently planning an advisory committee meeting. If approved, BBP-418 would be the first and only therapy for LGMD2I/R9 and the first approved treatment for any form of LGMD, addressing a significant unmet medical need for approximately 7,000 individuals in the U.S. and Europe. The Phase 3 FORTIFY trial demonstrated strong efficacy, with treated individuals improving across all key endpoints.

BridgeBio Pharma, Inc. announced the submission of a New Drug Application (NDA) to the FDA for encaleret, a potential targeted treatment for autosomal dominant hypocalcemia type 1 (ADH1). The submission is supported by positive Phase 3 CALIBRATE trial results, which met all primary and key secondary efficacy endpoints, demonstrating rapid and durable benefits. If approved, encaleret could be the first therapy specifically indicated for ADH1, with a U.S. launch anticipated in early 2027. The company also plans to submit an MAA to the EMA in the second half of 2026 and initiate a Phase 3 study for chronic hypoparathyroidism in Summer 2026.

BridgeBio Pharma submitted a New Drug Application (NDA) to the FDA for encaleret, a potential targeted treatment for autosomal dominant hypocalcemia type 1 (ADH1). This follows successful Phase 3 CALIBRATE trial results, where encaleret met all primary and key secondary efficacy endpoints, demonstrating rapid and durable benefits. If approved, encaleret could be the first specific therapy for ADH1, with a U.S. launch anticipated in early 2027. The company also plans to submit an MAA to the EMA in H2 2026 and initiate a Phase 3 study for chronic hypoparathyroidism in Summer 2026.

BridgeBio Pharma announced new Phase 3 ATTRibute-CM study data for acoramidis at Heart Failure 2026, demonstrating consistent and clinically meaningful benefits across the ATTR-CM disease spectrum. New findings showed acoramidis significantly reduced cardiovascular hospitalizations by 34% compared to tafamidis in an indirect comparison, with a favorable 28% hazard reduction in all-cause mortality. The data also highlighted acoramidis' ability to increase sTTR, significantly reduce sTTR variability, and drive early and sustained reductions in outpatient worsening heart failure, reinforcing its differentiated profile.

BridgeBio Pharma's compensation committee approved equity grants of 115,007 restricted stock units (RSUs) to 52 new employees. These grants are intended as an inducement for their employment, in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over time, with one-fourth vesting on May 16, 2027, and the remainder vesting quarterly thereafter, contingent on continued employment.