BridgeBio Pharma Inc.'s stock BBIO skyrocketed 66% in premarket trade Monday, following the announcement of positive results in a late-stage trial for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). This condition is characterized by the accumulation of faulty proteins on the heart, which can lead to heart failure.
Acoramidis Trial yields Promising Results
The Palo Alto, Calif.-based pharmaceutical company reported that their Phase 3 trial of acoramidis achieved a highly statistically significant result in its primary endpoint. Additionally, the trial yielded clinically meaningful outcomes across several important measures including mortality, morbidity, function and quality of life.
Clinical Experts Endorse Breakthrough
Experts in the field have praised the trial's exceptional findings. According to Dr. Daniel Judge, a professor of medicine and cardiology at the Medical University of South Carolina, "The consistent and clinically meaningful benefits on survival, hospitalization, and additional measures of illness severity are truly remarkable."
Promising Survival Rate
An outstanding survival rate of 81% was observed in the acoramidis trial, compared to the 74% rate of the placebo group.
Future Regulatory Steps
BridgeBio Pharma Inc. aims to expedite the introduction of acoramidis to market. They plan to submit a New Drug Application to the U.S. Food and Drug Administration by the end of this year. Additionally, regulatory filings in other markets are anticipated to take place in 2024.
This news adds to an already impressive year for BridgeBio Pharma Inc., with their stock experiencing a remarkable 139% gain year-to-date. In comparison, the broader market represented by the S&P 500 has recorded a gain of 17%.
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