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Rigel Pharmaceuticals Files NDA for Thrombocytopenia Drug
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Rigel Pharmaceuticals, Inc. (RIGL - Free Report) recently announced that it has filed a new drug application (NDA) to the FDA, seeking approval for its oral spleen tyrosine kinase inhibitor, fostamatinib for the treatment of patients with chronic and persistent immune thrombocytopenia (ITP).
Please note that fostamatinib was previously granted orphan drug designation by FDA for the given indication.
Rigel’s shares have significantly outperformed the Zacks classified Medical-Drugs industry so far this year. Shares of the company gained 32.8% while the industry registered an increase of 0.7%.
Coming back to the latest news, the NDA 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). fostamatinib met the primary endpoint in the first of two phase III studies of the FIT (fostamatinib in thrombocytopenia) clinical program.
Results from the study demonstrated that 18% of the patients who received fostamatinib achieved a stable platelet response (achieving greater than 50,000 platelets per uL of blood on at least four of the last six scheduled visits between weeks 14 and 24 of treatment) compared with patients who received no placebo control.
The company expects to receive a decision on the NDA’s acceptance by the FDA by June this year.
According to information provided by the company, about 60,000–125,000 adults suffer from primary chronic ITP in the U.S. Therapies that are currently available for the treatment of the disease includes steroids, blood platelet production boosters and splenectomy. Thus, approval of the drug will cater to the huge unmet medical need for patients suffering from the disease.
Meanwhile, Rigel is evaluating fostamatinib in phase II studies for indications like autoimmune hemolytic anemia and IgA nephropathy.
Rigel currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector are Heska Corporation , Galena Biopharma, Inc. and Aeglea Biotherapeutics, Inc. . Each of these stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 60 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Galena’s loss per share estimates narrowed from $1.12 to 58 cents for 2017 and over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 53.83%.
Aeglea’s loss per share estimates narrowed from $3.64 to $2.48 for 2017 over the last 30 days. The company’s shares gained 73.3% so far this year.
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Rigel Pharmaceuticals Files NDA for Thrombocytopenia Drug
Rigel Pharmaceuticals, Inc. (RIGL - Free Report) recently announced that it has filed a new drug application (NDA) to the FDA, seeking approval for its oral spleen tyrosine kinase inhibitor, fostamatinib for the treatment of patients with chronic and persistent immune thrombocytopenia (ITP).
Please note that fostamatinib was previously granted orphan drug designation by FDA for the given indication.
Rigel’s shares have significantly outperformed the Zacks classified Medical-Drugs industry so far this year. Shares of the company gained 32.8% while the industry registered an increase of 0.7%.
Coming back to the latest news, the NDA 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). fostamatinib met the primary endpoint in the first of two phase III studies of the FIT (fostamatinib in thrombocytopenia) clinical program.
Results from the study demonstrated that 18% of the patients who received fostamatinib achieved a stable platelet response (achieving greater than 50,000 platelets per uL of blood on at least four of the last six scheduled visits between weeks 14 and 24 of treatment) compared with patients who received no placebo control.
The company expects to receive a decision on the NDA’s acceptance by the FDA by June this year.
According to information provided by the company, about 60,000–125,000 adults suffer from primary chronic ITP in the U.S. Therapies that are currently available for the treatment of the disease includes steroids, blood platelet production boosters and splenectomy. Thus, approval of the drug will cater to the huge unmet medical need for patients suffering from the disease.
Meanwhile, Rigel is evaluating fostamatinib in phase II studies for indications like autoimmune hemolytic anemia and IgA nephropathy.
Rigel Pharmaceuticals, Inc. Price
Rigel Pharmaceuticals, Inc. Price | Rigel Pharmaceuticals, Inc. Quote
Zacks Rank & Key Picks
Rigel currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector are Heska Corporation , Galena Biopharma, Inc. and Aeglea Biotherapeutics, Inc. . Each of these stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 60 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Galena’s loss per share estimates narrowed from $1.12 to 58 cents for 2017 and over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 53.83%.
Aeglea’s loss per share estimates narrowed from $3.64 to $2.48 for 2017 over the last 30 days. The company’s shares gained 73.3% so far this year.
5 Trades Could Profit "Big-League" from Trump Policies
If the stocks above spark your interest, wait until you look into companies primed to make substantial gains from Washington's changing course.
Today Zacks reveals 5 tickers that could benefit from new trends like streamlined drug approvals, tariffs, lower taxes, higher interest rates, and spending surges in defense and infrastructure. See these buy recommendations now >>