BridgeBio Pharma, Inc.'s acoramidis is awaiting FDA's approval decision for transthyretin amyloidosis, with strong clinical data suggesting a likely approval and potential “blockbuster” status. The PDUFA date is 29th Nov. Despite past setbacks, including a Phase 3 failure, recent data shows significant improvements in survival rates and cardiovascular-related hospitalizations, bolstering the ap...
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (“BBOT” or the “Company”), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, has announced that the first patient has been dosed with BBO-10203 in the BREAKER-101 trial. BBO-10203 is a first-in-class orally bioavailable RAS:PI3Ka breaker that blocks the interaction betw...
- Continued, progressive improvement in motor function and achievement of motor milestones at 12-months post-treatment represents an important and statistically significant change, in contrast to the disease course observed in BridgeBio's ongoing CANinform natural history comparator study
PALO ALTO, Calif., Oct. 03, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, announced today that outcomes data through 42 months from the ongoing long-term open-label extension of ATTRibute-CM, its Phase 3 study of acoramidis in ATTR-CM, will be shared in a featured science o...
- Study exceeded target enrollment, with an expected topline data readout from the interim analysis expected in 2025 - BridgeBio believes there is an opportunity to pursue Accelerated Approval in the U.S. for BBP-418 in LGMD2I/R9 based on a potential biomarker surrogate endpoint of glycosylated alpha-dystroglycan (αDG) at time of the interim analysis - If successful, BBP-418 could be the first ...
- Acoramidis treatment led to a highly significant reduction in all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVH) at Month 30 compared with placebo
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