Rigel Pharmaceuticals, Inc. (RIGL - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending a marketing approval for Tavalisse (fostamatinib disodium hexahydrate) to treat adult patients with chronic immune thrombocytopenia (ITP), who are refractory to other therapies.
The positive response will now be reviewed by the European Commission (EC), which is expected to give a decision within the next 70 days. Rigel’s partner in Europe, Grifols, is preparing for a potential commercial launch in 2020.
Notably, in October 2018, the EMA accepted the marketing authorization application (MAA) for Tavalisse.
Shares of Rigel have inched up 1.8% so far this year compared with the industry’s increase of 6.1%.
We remind investors that in April 2018, Tavalisse was approved by the FDA and was commercially unveiled in the United States in the following month.
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.
Tavalisse generated sales of $29.9 million in the United States during the first nine months of 2019, reflecting a significant increase year over year. A potential approval in Europe will further boost the drug’s sale in the future quarters. Per the company, Europe is the second largest market for adult chronic ITP treatments after the United States.
Rigel is also conducting a phase III study on fostamatinib for treating patients with autoimmune hemolytic anemia (AIHA), a serious blood disorder. Meanwhile, the company has several candidates, which are being clinically developed with its partners BerGenBio AS, Daiichi Sankyo and Aclaris Therapeutics (ACRS - Free Report) .
Zacks Rank & Stocks to Consider
Rigel currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Jazz Pharmaceuticals PLC (JAZZ - Free Report) and Redhill Biopharma Ltd. (RDHL - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Jazz’s earnings estimates have been revised 5.6% upward for 2018 and 2.8% for 2019 over the past 60 days. The stock has rallied 11.8% so far this year.
Redhill’s loss per share estimates have been narrowed 6.9% for 2019 and 25.5% for 2020 over the past 60 days. The stock has gained 12.6% year to date.
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