Pfizer Inc. said Thursday that a Phase 3 study of fidanacogene elaparvovec for the treatment of hemophilia B in adult males met its primary endpoint of superiority in the annualized bleeding rate (ABR). The drug maker PFE said key secondary endpoints demonstrated a 78% reduction in treated ABR and a 92% reduction in annualized infusion rate. Pfizer said fidanacogene was also “well tolerated,” and in line with Phase 1/2 results. There were 14 serious adverse events (SAEs) reported in seven, or 16%, of patients, with two assessed as related to treatment, and no deaths. “The [Phase 3 study] data demonstrate the promise of this gene therapy candidate as a potential one-time option for people living with hemophilia B as a means of reducing the clinical and treatment burden over the long term,” said Adam Cuker, director, Penn Comprehensive and Hemophilia Thrombosis Program. Pfizer’s stock, which was little changed in premarket trading, has rallied 15.0% over the past three months, while the SPDR Health Care Select Sector ETF XLV has climbed 9.8% and the S&P 500 SPX has tacked on 3.9%.
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