BridgeBio Pharma Inc.’s stock BBIO rocketed 66% in premarket trade Monday, after the company announced positive results in a late-stage trial of a treatment for transthyretin amyloid cardiomyopathy, or ATTR-CM, a buildup of faulty proteins on the heart that can cause heart failure. The Palo Alto, Calif.-based company said the Phase 3 trial of acoramidis achieved a highly statistically significant result on primary endpoint and clinically meaningful results on all measures of mortality, morbidity, function and quality of life. “The consistent and clinically meaningful benefits on survival, hospitalization, and additional measures of illness severity are truly remarkable,” said Dr. Daniel Judge, professor of medicine and cardiology at the Medical University of South Carolina, in a statement. The trial achieved an 81% survival rate, versus 74% on placebo. The company intends to submit a New Drug Application to the U.S. Food and Drug Administration before year-end and will follow on with regulatory filings in other markets in 2024. The stock has gained 139% in the year to date, while the S&P 500 SPX has gained 17%.
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