FDA reviewing Rigel's Tavalisse for ITP

Rigel Pharmaceuticals Inc. (NASDAQ:RIGL) gained $0.28 (11%) to $2.78 on Monday after it said FDA accepted for review its NDA for Tavalisse fostamatinib to treat chronic or persistent idiopathic thrombocytopenic purpura. The candidate's PDUFA date is April 17, 2018.

The submission includes data from three Phase III studies of Tavalisse to treat ITP, including two placebo-controlled studies and an open-label extension trial. Tavalisse missed the primary endpoint of one of the placebo-controlled trials, but Rigel has said pooled data showed the therapy led to significant improvements in platelet response rate vs. placebo (see BioCentury Extra, Oct. 20, 2016)...