Business
BridgeBio Pharma Reports Third Quarter 2021 Financial Results and Business Update
--Topline results from Part A of the Phase 3 ATTRibute-CM trial of TTR stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM) expected by end of 2021
About this update from Bridgebio Pharma, Inc.
[{"type":"text","content":"--Topline results from Part A of the Phase 3 ATTRibute-CM trial of TTR stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM) expected by end of 2021\n --Meaningful progress in RAS cancer portfolio with discovery of next-generation KRAS G12C dual inhibitors and novel PI3ka:RAS breakers\n --Advancements in gene therapy pipeline with first patient dosed in Canavan disease trial and newly announced program targeting classic galactosemia (severe GALT deficiency)\n --Company repurchased $148.4 million in BridgeBio common stock under 2021 Share Repurchase Program, demonstrating the Company's confidence in the long-term prospects of its pipeline\n --Ended quarter with $599.6 million in cash, cash equivalents and marketable securities\n\n\nPALO ALTO, Calif., Nov. 4, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today reported its financial results for the third quarter ended September 30, 2021 and provided an update on the Company's operations.\n\n \n \n \n \n \n \n\n \nBridgeBio has more than 30 programs in its pipeline for patients living with genetic diseases and cancers and 20 ongoing clinical trials underway across more than 450 sites around the world. Earlier this year BridgeBio received its first two U.S. Food and Drug Administration (FDA) drug approvals and has successfully filed 15 Investigational New Drug (IND) applications since the Company's founding in 2015.\nBridgeBio's four core value drivers:\nAcoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM): Topline results from Part A of the Phase 3 ATTRibute-CM trial are expected in late 2021 and from Part B in 2023. The primary endpoint at Part A is the change from baseline in a 6-minute walk distance (6MWD) in trial participants receiving acoramidis or placebo after 12 months. If the change from baseline in 6MWD in Part A is highly statistically significant, BridgeBio expects to submit an application for regulatory approval of acoramidis in 2022 to the FDA. The study enrolled more than 600 subjects with either wild-type or variant TTR across more than 80 sites in 18 countries. ATTR-CM is a rare heart condition with a progressive and debilitating impact on quality of life likely affecting more than 4...