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Kiniksa Provides Update on U.S. FDA Review of Investigational New Drug Application for Mavrilimumab in Giant Cell Arteritis

Kiniksa Pharmaceuticals Ltd CL A (KNSA)  More Company Research Source: GlobeNewswire
Last kiniksa pharmaceuticals ltd cl a earnings: 11/1 08:00 am Check Earnings Report
PDF HAMILTON, Bermuda, Dec. 06, 2018 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline consisting of five product candidates across various stages of development, focused on autoinflammatory and autoimmune conditions, today announced that the U.S. Food and Drug Administration (FDA) requested additional information regarding the delivery device to be used in the company’s Phase 2 clinical trial of mavrilimumab in giant cell arteritis. In light of its device-related information request, the FDA placed the company’s recently-submitted investigational new drug application (IND) on clinical hold. The device-related information request does not pertain to preclinical toxicology data nor the design of the company’s Phase 2 clinical trial. The delivery device is 510(k)-cleared, and the company is providing the requested information. “Mavrilimumab has the potential to be a differentiated treatment option for giant cell arte [Read more]

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