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Rigel (RIGL) Stock Up on Positive Phase III Fostamatinib Data
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Shares of Rigel Pharmaceuticals, Inc. (RIGL - Free Report) shot up 48.9% after the company announced favorable data on its oral spleen tyrosine kinase inhibitor, fostamatinib, for the treatment of adult chronic/persistent immune thrombocytopenia (ITP).
Fostamatinib met the primary endpoint in the first of two phase III studies of the FIT 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 14–24 of treatment) compared to none receiving a placebo control.
Patients meeting the primary endpoint reported an increase in platelet count from a median of 16,000/uL at baseline to a median of more than 100,000/uL at week 24. Thereafter, the patients were enrolled in a long-term phase III extension study, wherein they witnessed mostly unchanged platelet levels for months beyond the initial study period of 24 weeks. Data from the extension study will be presented at future medical meetings.
Fostamatinib is also being evaluated in the second phase III study of the FIT clinical program with results expected in Oct–Nov 2016.
Rigel anticipates filing a New Drug Application (NDA) for fostamatinib in the U.S. in the first quarter of 2017. In the U.S., the candidate enjoys Orphan Drug Status for the treatment of ITP.
According to information provided by the company, about 50,000–60,000 adults suffer from primary chronic ITP in the U.S. Therapies that are currently available to treat the disease include steroids, blood platelet production boosters and splenectomy.
Meanwhile, Rigel is also evaluating fostamatinib in phase II studies for indications such as autoimmune hemolytic anemia and IgA nephropathy.
Rigel currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. (PCRX - Free Report) , Anika Therapeutics Inc. (ANIK - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy).
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Rigel (RIGL) Stock Up on Positive Phase III Fostamatinib Data
Shares of Rigel Pharmaceuticals, Inc. (RIGL - Free Report) shot up 48.9% after the company announced favorable data on its oral spleen tyrosine kinase inhibitor, fostamatinib, for the treatment of adult chronic/persistent immune thrombocytopenia (ITP).
Fostamatinib met the primary endpoint in the first of two phase III studies of the FIT 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 14–24 of treatment) compared to none receiving a placebo control.
Patients meeting the primary endpoint reported an increase in platelet count from a median of 16,000/uL at baseline to a median of more than 100,000/uL at week 24. Thereafter, the patients were enrolled in a long-term phase III extension study, wherein they witnessed mostly unchanged platelet levels for months beyond the initial study period of 24 weeks. Data from the extension study will be presented at future medical meetings.
RIGEL PHARMCTCL Price
RIGEL PHARMCTCL Price | RIGEL PHARMCTCL Quote
Fostamatinib is also being evaluated in the second phase III study of the FIT clinical program with results expected in Oct–Nov 2016.
Rigel anticipates filing a New Drug Application (NDA) for fostamatinib in the U.S. in the first quarter of 2017. In the U.S., the candidate enjoys Orphan Drug Status for the treatment of ITP.
According to information provided by the company, about 50,000–60,000 adults suffer from primary chronic ITP in the U.S. Therapies that are currently available to treat the disease include steroids, blood platelet production boosters and splenectomy.
Meanwhile, Rigel is also evaluating fostamatinib in phase II studies for indications such as autoimmune hemolytic anemia and IgA nephropathy.
Rigel currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. (PCRX - Free Report) , Anika Therapeutics Inc. (ANIK - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy).
Confidential from Zacks
Beyond this Tale of the Tape, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>