BridgeBio Announces Commercial Progress, Program Updates, and 2025 Milestones

Commercial Progress and FDA Approval - Attruby (acoramidis) received FDA approval on November 22, 2024, marking a significant milestone for the company and the ATTR-CM patient community [1][8] - Since approval, 430 prescriptions have been written by 248 unique physicians, indicating strong initial commercial momentum [1][7][8] - Attruby is indicated to reduce cardiovascular death and cardiovascular-related hospitalization in adult patients with ATTR-CM, a progressive fatal disease [8][10] Pipeline Updates and Clinical Trials - The company has completed enrollment for all three major Phase 3 clinical trials: FORTIFY (BBP-418 for LGMD2I/R9), CALIBRATE (encaleret for ADH1), and PROPEL 3 (infigratinib for achondroplasia) [2][7][9] - FORTIFY, a Phase 3 trial for BBP-418, is fully enrolled with 112 patients, with Last Patient – Last Visit (LPLV) and topline readout expected in the second half of 2025 [9] - CALIBRATE, a Phase 3 trial for encaleret, is fully enrolled with 70 patients, with LPLV and topline readout expected in the second half of 2025 [9] - PROPEL 3, a Phase 3 trial for infigratinib, is fully enrolled with 114 participants, with Last Participant – Last Visit expected in the second half of 2025 [9] Financial and Regulatory Milestones - The company is well-financed with $406 million in cash as of the last quarter and received$500 million upon FDA approval of acoramidis from a royalty facility [7] - Anticipated regulatory milestones include $105 million in the first half of 2025 from acoramidis approvals in Europe and Japan [7] - EU and Japan approvals for acoramidis are expected in the first half of 2024 [3] Product Potential and Market Impact - If successful, BBP-418 would be the first approved therapy for LGMD2I/R9, a rare genetic disorder causing progressive muscle degeneration [9] - Encaleret could become the first approved therapy for ADH1, a rare genetic form of hypoparathyroidism [9] - Infigratinib has the potential to be the first approved oral therapy for children with achondroplasia, the most common form of disproportionate short stature [9] Company Overview - BridgeBio Pharma is a biopharmaceutical company focused on discovering and delivering transformative medicines for genetic diseases [11] - Founded in 2015, the company has a pipeline ranging from early science to advanced clinical trials [11]