Shares of Rigel Pharmaceuticals (NASDAQ: RIGL) climbed 17% higher this morning after the company said the U.S. Food and Drug Administration (FDA) has filed its New Drug Application (NDA) for the use of TAVALISSE™ in patients with chronic or persistent immune thrombocytopenia (ITP). Data from all studies, such as preclinical evaluation and drug manufacturing data, were included in the NDA submission. Based on the Prescription Drug User Fee Act, Rigel anticipates the action date for the FDA to complete its review will be April 17, 2018. The FDA has previously granted Orphan Drug designation to TAVALISSE™ for the treatment of patients with ITP. “If approved, we believe TAVALISSE™ will provide a new treatment option for patients with chronic or persistent ITP. We look forward to working closely with the FDA as they review our submission,” Rigel president and chief executive officer Raul Rodriguez stated in the news release.
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Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematological disorders, cancer and rare diseases. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company’s current clinical programs include clinical trials of fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in a number of indications. Rigel has submitted an NDA to the FDA for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP). In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo and Aclaris Therapeutics. For more information, visit www.rigel.com.
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