Shares of BridgeBio Pharma, Inc. (BBIO) jumped 25% on Monday morning after the U.S. Food and Drug Administration approved Attruby or acoramidis for the treatment of adults with Transthyretin amyloid cardiomyopathy (ATTR-CM) to reduce cardiovascular death and hospitalization.
BBIO is currently trading at $29.46, up $6.04 or 25.79%, on the Nasdaq. The stock opened its trading at $28.80 after closing Friday at $23.42. The stock has traded between $21.62 and $44.32 in the past 52-week period.
FDA's approval came through late Friday. The approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular-related hospitalization, and improved quality of life.
BridgeBio has submitted a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025. BridgeBio has granted exclusive rights to Bayer to commercialize acoramidis for ATTR-CM in Europe.
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