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April 7, 2024
- In this exploratory substudy, treatment with acoramidis was associated with possible cardiac structural and functional improvement compared with placebo, with potential cardiac amyloid regression -...
February 22, 2024
- Submitted New Drug Application to US Food and Drug Administration for acoramidis for the treatment of transthyretin amyloid cardiomyopathy based on positive results of Phase 3 ATTRibute-CM trial,...
February 7, 2024
ATTRibute-CM results also demonstrated rapid clinical benefit on the composite endpoint of all-cause mortality (ACM) and CVH in patients treated with acoramidis, with time-to-first event Kaplan-Meier curves separating at month 3 and continuing to diverge steadily through Month 30
February 2, 2024
- Phase 3 open-label, single-arm study conducted in Japan by BridgeBio licensing partner Alexion, AstraZeneca Rare Disease showed consistency with global ATTRibute-CM Phase III trial - No mortality...
January 12, 2024
ATTRibute-CM demonstrated a significant treatment effect of acoramidis on the primary endpoint (a hierarchical analysis inclusive of all-cause mortality (ACM) and frequency of cardiovascular-related hospitalization (CVH)), with a Win Ratio of 1.8 (p
January 10, 2024
ATTRibute-CM demonstrated a significant treatment effect of acoramidis on the primary endpoint (a hierarchical analysis inclusive of all-cause mortality (ACM)…
January 10, 2024
- ATTRibute-CM demonstrated a significant treatment effect of acoramidis on the primary endpoint and frequency of cardiovascular-related hospitalization ), with a Win Ratio of 1.8 - Acoramidis...
December 26, 2023
CVRx, Inc. announced that the U.S. Food and Drug Administration has approved revised Instructions For Use for Barostim incorporating key long-term clinical data from the BeAT-HF randomized clinical...
December 5, 2023
- 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<0.0001), on the primary
November 21, 2023
The company intends to file a New Drug Application (NDA) for acoramidis with the U.S. Food and Drug Administration (FDA) by end of 2023