Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO)
Ultragenyx Pharmaceutical Inc. (RARE)
Last ultragenyx pharmaceutical inc. earnings: 2/13 04:01 pm
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Source: GlobeNewswire
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 designation in February 2020. “Approximately half of patients with TIO have tumors that cannot be surgically removed, leaving them with no other current treatment options,” said Camille L. Bedrosian, M.D., Chief Medical Officer of Ultragenyx. “We look forward to continuing to work c
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- Ultragenyx Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) had its "buy" rating re-affirmed by analysts at Canaccord Genuity Group Inc.. They now have a $121.00 price target on the stock.MarketBeat
- Ultragenyx Presents Positive Update on GTX-102 Angelman Syndrome Program at FAST’s 17th Annual Global Science SummitGlobeNewswire
- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) had its price target raised by analysts at Canaccord Genuity Group Inc. from $109.00 to $121.00. They now have a "buy" rating on the stock.MarketBeat
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Earnings
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Sec Filings
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