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Rigel clinches its first approval with ITP drug
FDA approved an NDA from Rigel Pharmaceuticals Inc. (NASDAQ:RIGL) for Tavalisse fostamatinib to treat chronic idiopathic thrombocytopenic purpura in adults who have had an insufficient response to a previous treatment. The oral spleen tyrosine kinase (SYK) inhibitor is the company's first product to be approved by any regulatory agency since its founding in 1996.
Rigel expects to launch Tavalisse late next month. A Rigel spokesperson declined to disclose the drug's wholesale acquisition cost (WAC).
Tavalisse is also in Phase II testing to treat autoimmune hemolytic anemia (see BioCentury Extra, April 3).
Rigel added $0.38 (10%) to $4.11 before trading was suspended in the afternoon ahead of the announcement. The stock was up a further $0.32 to $4.55 in after-hours trading.
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