The Latest Cardiac and Vascular News
– Accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; FDA not currently planning to hold an advisory committee meeting to discuss application – Marketing Authorization Application accepted by the European Medicines Agency (EMA) with […]
PALO ALTO, Calif., Dec. 05, 2023 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that it has submitted an NDA for acoramidis to the U.S. […]
– Presented detailed positive results from the ATTRibute-CM Phase 3 study of acoramidis at the European Society of Cardiology (ESC) Congress, demonstrating that patients survived more and were hospitalized less than has been seen in other interventional studies of transthyretin […]
PALO ALTO, Calif., Aug. 27, 2023 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced the presentation of detailed positive results from its Phase 3 ATTRibute-CM […]
PALO ALTO, Calif., July 17, 2023 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), is a commercial-stage biopharmaceutical company focused on genetic diseases and cancers. Today, alongside the dedicated physicians and courageous patients who participated, the […]
–Phase 3 ATTRibute-CM registrational trial of acoramidis for transthyretin amyloid cardiomyopathy (ATTR-CM) continues to have high operating fidelity; month 30 topline registrational data are expected to be announced in mid-2023 –Phase 2 PROPEL 2 trial of low-dose infigratinib as a […]
– Reported positive interim Phase 2 data for infigratinib in achondroplasia demonstrating a mean increase in annualized height velocity (AHV) of 1.52 cm/year among all Cohort 4 children 5 years of age and older, and announced addition of a 5th cohort to […]
–Completed sale to Sentynl Therapeutics of BridgeBio’s NULIBRY™ (Fosdenopterin) for Injection –Updated strategic collaboration with Helsinn Group to develop, manufacture and commercialize infigratinib in oncology indications in the U.S.; BridgeBio is eligible to receive regulatory and commercial milestone payments as well […]
– NT-proBNP, a biomarker of cardiac failure and independent predictor of mortality in ATTR-CM patients, was stable or improving throughout the study. At Month 30, median change from baseline in NT-proBNP was -437 pg/mL with 68% of participants observing NT-proBNP […]
– ATTRibute-CM did not meet its primary endpoint at Month 12. Mean observed six-minute walk distance (6MWD) decline for the acoramidis and placebo arms were 9 meters and 7 meters, respectively. Both declines are similar to healthy elderly adults and […]
