Core Insights - Acoramidis has shown a significant impact on mortality, hospitalizations, and quality of life in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), demonstrating a 42% reduction in composite cardiovascular hospitalization (CVH) and all-cause mortality (ACM) events relative to placebo by Month 30 [1][4][5] - The company reported a net loss attributable to common stockholders of 157.9 million for the same period in 2023, indicating improved financial performance [14] - The company ended the quarter with 392.6 million at the end of 2023 [6] Pipeline Overview - Acoramidis for ATTR-CM has an NDA filed with the FDA, with a PDUFA date set for November 29, 2024 [2] - Encaleret for autosomal dominant hypocalcemia type 1 (ADH1) is currently enrolling in the CALIBRATE Phase 3 study, with enrollment completion expected in 2024 [2] - BBP-418 for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) is also enrolling in the FORTIFY Phase 3 study, with completion anticipated in 2024 [2] - Low-dose infigratinib for achondroplasia and hypochondroplasia is enrolling in the PROPEL 3 Phase 3 study, with completion expected in 2024 [2] Financial Performance - Revenue for the three months ended June 30, 2024, was 1.6 million in the same period in 2023, primarily due to recognition of services revenue under collaboration agreements [7] - Operating costs and expenses for the three months ended June 30, 2024, were 147.7 million for the same period in 2023, driven by increased selling, general, and administrative expenses [8][9] - Total other income for the three months ended June 30, 2024, was 14.6 million in the same period in 2023, mainly due to a gain on deconsolidation of a subsidiary [12][13] Clinical Developments - Acoramidis treatment resulted in a statistically significant reduction in ACM in the intention-to-treat population at Month 30, with no safety signals of concern [1][5] - The company shared positive analyses at various conferences, including a significant improvement in health-related quality of life as assessed by the EuroQoL Health Outcomes Assessment tool [5] - Infigratinib for achondroplasia showed a statistically significant increase in annualized height velocity, with a mean change of +2.50 cm/year at Month 18 [1][4]
BridgeBio Pharma Reports Second Quarter 2024 Financial Results and Business Update