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Rigel (RIGL) Gets EMA Acceptance for Thrombocytopenia Drug

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Rigel (RIGL) Gets EMA Acceptance for Thrombocytopenia Drug

The EMA validates Rigel Pharmaceuticals' (RIGL) marketing application for thrombocytopenia drug, Tavalisse.

Rigel Pharmaceuticals, Inc. RIGL announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA), seeking approval for Tavalisse (fostamatinib disodium hexahydrate) for the treatment of chronic immune thrombocytopenia (ITP) in adult patients. The validation was received last week, which initiated the MAA review process.

Rigel expects a decision from the Committee on Human Medicinal Products in the fourth quarter of 2019. The company plans to enter into partnership with third parties to commercialize Tavalisse in Europe and Asia.

In April 2018, Tavalisse was approved by the FDA and was commercially launched in the United States in the following month. Now, the company is diligently trying to pursue a European commercial collaboration next year and make the drug available for patients suffering from chronic ITP.

Shares of the company went up 1.6%, following the announcement of the news. However, the stock has lost 20.1% year to date compared with the industry’s decrease of 6.1%.


Tavalisse, an oral spleen tyrosine kinase (SYK) inhibitor, is the company’s first approved product indicated for the treatment of adult patients with chronic ITP who were not responding to any previous treatment. It is the first and only FDA approved drug for the treatment of thrombocytopenia.

In the second quarter of 2018, Tavalisse generated $1.8 million of net sales in the United States.

Notably, Rigel is also conducting phase II studies of fostamatinib in autoimmune hemolytic anemia and IgA nephropathy, and a phase I study for its interleukin receptor associated kinase (IRAK) program. The company has several other candidates, which are being clinically developed with its partners — BerGenBio AS, Daiichi Sankyo and Aclaris Therapeutics ACRS.

Zacks Rank & Stocks to Consider

Rigel Pharmaceuticals currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector are Endo International plc ENDP and United Therapeutics Corporation UTHR, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Endo International’s earnings estimates have moved 0.8% north for 2018 and 0.7% for 2019 over the past 60 days. The stock has skyrocketed 116.8% so far this year.

United Therapeutics’ earnings estimates have been revised 3.6% upward for 2018 and 2.3% for 2019 over the past 60 days.

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