BridgeBio: With HELIOS-B Overhang Removed, Focus To Turn To Approval And Launch Of Acoramidis

Core Viewpoint - BridgeBio's stock performance has been disappointing despite positive developments such as the upcoming FDA approval for acoramidis, strong phase 2 data for infigratinib, and the spinout of its oncology unit and early-stage rare disease drugs into GondolaBio [2][9] Company Developments - Acoramidis is positioned to capture market share in the growing ATTR cardiomyopathy market, with recent data showing it has a 42% reduction in all-cause mortality and cardiovascular hospitalizations at month 30, compared to 25% for tafamidis and 28-33% for Amvuttra [4][6] - The HELIOS-B trial results have alleviated concerns regarding acoramidis' competitive position against Amvuttra, allowing investors to focus on BridgeBio's own pipeline and upcoming regulatory events [9][13] - The company has a strong pipeline with late-stage candidates including infigratinib for achondroplasia and encaleret for autosomal dominant hypocalcemia type 1, both of which are expected to deliver positive results in upcoming trials [10][13] Market Context - The ATTR cardiomyopathy market is projected to exceed $15 billion globally by the early 2030s, with acoramidis and Amvuttra potentially generating $2-3 billion in annual net sales by the late 2020s [8] - Tafamidis is expected to remain the market leader initially due to its first-mover advantage, but acoramidis and Amvuttra are anticipated to compete closely and may surpass tafamidis by the early 2030s [8] Regulatory and Financial Outlook - The key upcoming event for BridgeBio is the PDUFA date for acoramidis in late November, which poses a significant risk but also an opportunity for revenue growth if approved [9][12] - If acoramidis is approved, it is expected to exceed the revenue consensus of $236 million for the following year, driven by its strong clinical profile and the size of the ATTR CM market [9][10] - The company has a solid financial position with $587 million in cash and equivalents, and additional funding contingent on acoramidis' FDA approval [12]