2023-07-17 12:05:29 ET
Shares of BridgeBio ( NASDAQ: BBIO ) shot up 80% in midday trading Monday after the biotech company said it plans to file for US regulatory approval of its drug acoramidis by the end of the year after releasing positive Phase 3 data for the drug in the treatment of ATTR-CM.
BridgeBio shares opened at $26.76, recently changing hands at $32.81 at around 11:55 a.m. ET.
Earlier Monday, BridgeBio said the Phase 3 study showed an on-treatment survival rate of 81% for patients who took acoramidis versus 74% for those who took a placebo. The company also reported a "highly statistically significant" relative risk reduction of 50% for frequency of cardiovascular-related hospitalizations.
ATTR-CM, or transthyretin amyloid cardiomyopathy, is a potentially life-threatening disease of the heart muscle that can lead to heart failure.
BridgeBio added that it plans to file a new drug application for acoramidis with the FDA by the end of 2023, with filings for approvals in additional markets anticipated in 2024.
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BridgeBio stock soars 80% on Phase 3 data, filing update for heart drug