05.12.2023 14:18:40
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BridgeBio Pharma Announces NDA Submission For Acoramidis - Quick Facts
(RTTNews) - BridgeBio Pharma, Inc. (BBIO) has submitted an NDA for acoramidis to the FDA for the treatment of Transthyretin Amyloid Cardiomyopathy or ATTR-CM. The application was based on positive results from ATTRibute-CM, the Phase 3 study.
The company noted that FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review. The company plans to submit additional marketing authorization applications to global health authorities in 2024.
BridgeBio is a commercial-stage biopharmaceutical company founded to discover transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers.
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