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Regado slips on Revolixys trial halt

July 3, 2014 10:35 PM UTC

Regado Biosciences Inc. (NASDAQ:RGDO) fell $3.92 (58%) to $2.84 on Thursday after announcing late Wednesday that it halted enrollment in the Phase III REGULATE-PCI trial with its Revolixys Kit (formerly REG1) to treat acute coronary syndrome (ACS) in patients undergoing percutaneous coronary intervention (PCI).

The company halted enrollment after an independent DSMB initiated an unplanned review of the 3,234 patients enrolled due to serious adverse events related to potential allergic reactions. On a conference call to discuss the trial halt, Regado said it expects the DSMB to complete its review within the next eight weeks. Enrollment will not resume until the review is completed and findings are communicated. Regado declined to provide additional details. Revolixys is composed of pegnivacogin ( RB006), a pegylated, single-stranded RNA aptamer that binds to Factor IXa, and anivamersen ( RB007), a complementary single-stranded RNA containing a 15-nucleotide sequence that binds to and neutralizes pegnivacogin. ...