Shares of Rigel Pharmaceuticals RIGL moved up by 16% as it awaits FDA’s decision on its lead pipeline candidate Tavalisse (fostamatinib) on Apr 17. The jump in share price could also be because the company’s website described tavalisse (fostamatinib) as "the company's first FDA approved product”. However, this was actually not the case and the company issued a statement clarifying that due to an error of the external host of its investor relations website, inaccurate information was displayed. Management informed that the mistake has been rectified on the website. Rigel currently does not have any marketed product in its portfolio.
Tavalisse is being evaluated for the treatment of chronic immune thrombocytopenia (“ITP”). Rigel is preparing for the launch of this oral spleen tyrosine kinase inhibitor in the second quarter of 2018, if approved. Existing therapies to treat chronic ITP include steroids, blood platelet production boosters and splenectomy. However, still the disease remains inadequately treated in many patients. This means that if approved, Tavalisse should enjoy significant market potential.
The new drug application for tavalisse was filed in April 2017 and was supported by positive data from three phase III studies comprising two randomized placebo-controlled studies (Studies 047 and 048) and an open-label extension study (Study 049). Tavalisse met the primary endpoint in the first of two phase III studies of the fostamatinib in thrombocytopenia clinical program.
Over a year, shares of Rigel have returned 23.7% compared with the industry’s gain of 8.3%.
We note that another company, Novartis NVS also has a drug Promacta approved in the United States and Europe for the treatment of thrombocytopenia in pediatric patients 1 year or older with chronic ITP who have had an insufficient response to corticosteroids and immunoglobulins. The drug was acquired from GlaxoSmithKline GSK in March 2015. Novartis has a collaboration agreement with Ligand Pharmaceuticals LGND for the marketing of the drug.
Rigel Pharmaceuticals, Inc. Price
Rigel Pharmaceuticals, Inc. Price | Rigel Pharmaceuticals, Inc. Quote
Rigel carries a Zacks Rank #4 (Sell).
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