BridgeBio Pharma, Inc. 10-Q filed Oct 29, 2026

Modified · Overview

We currently generate material revenues from one commercial product and have multiple product candidates in that have advanced into registrational and late-stage development. Acoramidis received U.S. Food and Drug Administration (“FDA”) approval in November 2024 as Attruby and also received approval as Attruby from the Australian Therapeutic Goods Administration in late October 2026, and it received approval as Beyonttra from (i) the European Commission (“EC”) on February 10, 2025, (ii) the Japanese Ministry of Health, Labour and Welfare on March 27, 2025 (pricing approval from the National Health Insurance in Japan was subsequently obtained on May 21, 2025), and (iii) the United Kingdom Medicines and Healthcare Productsproducts Regulatory Agency in the UK in April 2025 and (iv) the Brazilian Health Regulatory Agency in Brazil in May 2026. On March 30, 2026, we submitted our New Drug Application (“NDA”) to the FDA for oral BBP-418 for the treatment of LGMD2I/R9. On May 27, 2026, the The FDA accepted our NDA for filing, granted Priority Review and assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of November 27, 2026, for BBP-418. On May 12, 2026, we submitted our NDA to the FDA for encaleret as a potential targeted treatment for ADH1. The FDA accepted our NDA for filing , granted Priority Review and assigned a PDUFA target action date of May 8, 2027, for encaleret. We On August 4, 2026, we submitted our NDA to the FDA for low-dose infigratinib for achondroplasia. The FDA accepted our NDA for filing, granted Priority Review and assigned a PDUFA target action date of February 4, 2027, for infigratinib.