Ultragenyx Pharma (RARE), Kyowa Kirin Report Submission of Supplemental Biologics License Application to FDA for Crysvita (burosumab)

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Go back to Ultragenyx Pharma (RARE), Kyowa Kirin Report Submission of Supplemental Biologics License Application to FDA for Crysvita (burosumab)

Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO)

January 13, 2020 8:01 AM EST

NOVATO, Calif. and TOKYO, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd., (Kyowa Kirin, TYO: 4151) today announced that they submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) on December 18, 2019, for Crysvita® (burosumab) for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (tumor-induced osteomalacia; TIO) that cannot be curatively resected or localized. The companies expect to hear back from FDA on submission acceptance and review... More