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ATTRibute-CM demonstrated a significant treatment effect of acoramidis on the primary endpoint (a hierarchical analysis inclusive of all-cause mortality (ACM)…
- 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...
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...
- 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
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