Ultragenyx Announces UX007 Granted Fast Track Designation and Rare Pediatric Disease Designation by U.S. FDA for Treatment of Long-Chain Fatty Acid Oxidation Disorders
Ultragenyx Pharmaceutical Inc. (RARE)
Last ultragenyx pharmaceutical inc. earnings: 2/13 04:01 pm
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Source: GlobeNewswire
NOVATO, Calif., April 16, 2019 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation and Rare Pediatric Disease designation to UX007 for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD), a group of genetic disorders in which the body is unable to convert long-chain fatty acids into energy. “These designations for UX007 underscore FDA’s belief that new treatments are needed for patients with LC-FAOD, a severe and potentially life-threatening disease. In addition, they offer the potential to speed up our ability to bring UX007 to patients,” said Camille L. Bedrosian, M.D., Chief Medical Officer of Ultragenyx. Ultragenyx is on track to submit a New Drug Application (NDA) in mid-2019. The submission will include data from a company-s
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- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) had its "neutral" rating re-affirmed by analysts at Wedbush. They now have a $48.00 price target on the stock.MarketBeat
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RARE
Earnings
- 2/15/24 - Beat
RARE
Sec Filings
- 4/19/24 - Form 4
- 4/18/24 - Form 4
- 4/15/24 - Form 8-K
- RARE's page on the SEC website