- NDA submission is based on positive results from ATTRibute-CM Phase 3 study, including a highly statistically significant result, demonstrated by a Win Ratio of 1.8 (p
BridgeBio Pharma Announces Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
On 6ix: 6ix.com/news/bridgebio-pharma-announces-submission-of-new-drug-application-nda-to-us-food-and
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Story so far
- BridgeBio Pharma Presents Additional Clinical Outcomes Data from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
- BridgeBio Pharma to Present Additional Data from the Phase 3 ATTRibute-CM Study in Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) at the American Heart Association (AHA) Scientific Sessions 2023
- BridgeBio Pharma Announces New England Journal of Medicine Publication of Positive Encaleret Proof-of-Concept Phase 2b Results in Patients with Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Earlier from BridgeBio Pharma
- BridgeBio Pharma Presents Additional Clinical Outcomes Data from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
- BridgeBio Pharma to Present Additional Data from the Phase 3 ATTRibute-CM Study in Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) at the American Heart Association (AHA) Scientific Sessions 2023
- BridgeBio Pharma Reports Third Quarter 2023 Financial Results and Business Update
- BridgeBio Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
- BridgeBio Pharma Announces New England Journal of Medicine Publication of Positive Encaleret Proof-of-Concept Phase 2b Results in Patients with Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Later from BridgeBio Pharma
- BridgeBio Announces First Child Dosed in PROPEL 3, its Phase 3 Clinical Trial for Infigratinib in Children with Achondroplasia
- BridgeBio announces FDA clearance of IND application for BBO-8520, a first-in-class direct inhibitor of KRASG12C (ON)
- BridgeBio Pharma Announces Publication of Positive Results from Phase 3 ATTRibute-CM Study of Acoramidis for Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in the New England Journal of Medicine
- BridgeBio Pharma Secures up to $1.25 Billion of Capital from Blue Owl and CPP Investments to Accelerate the Development and Launch of Genetic Medicines
- BridgeBio Pharma Shares Positive Results of Single-Arm Phase 3 Study of Acoramidis in Japanese Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Including No Mortality Reported in the Trial at 30 Months
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