ARTICLE | Clinical News

Rigel's fostamatinib meets in first ITP Phase III

August 30, 2016 7:00 AM UTC

Rigel Pharmaceuticals Inc. (NASDAQ:RIGL) surged $1.29 (49%) to $3.93 on Tuesday after its fostamatinib disodium (formerly R788) met the primary endpoint of stable platelet response in a double-blind, 76-patient Phase III study to treat chronic/persistent idiopathic thrombocytopenic purpura (ITP). The company plans to submit an NDA to FDA for the oral spleen tyrosine kinase (SYK) inhibitor by the end of 1Q17.

A significantly greater proportion of patients receiving 100 mg twice-daily fostamatinib achieved a stable platelet response by week 24 compared with placebo (18% vs. 0%, p=0.0261). A stable response was defined as platelet counts of at least 50,000/uL of blood for at least four of the final six qualifying blood draws. ...