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Ultragenyx Pharmaceutical Inc (RARE.OQ)

RARE.OQ on NASDAQ Stock Exchange Global Select Market

84.26USD
22 Jun 2018
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Latest Key Developments (Source: Significant Developments)

Ultragenyx Announces Filing And FDA Clearance Of An Investigational New Drug Application For DTX401
Monday, 23 Apr 2018 

April 23 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX ANNOUNCES FILING AND FDA CLEARANCE OF AN INVESTIGATIONAL NEW DRUG APPLICATION FOR DTX401, A GENE THERAPY FOR THE TREATMENT OF GLYCOGEN STORAGE DISEASE TYPE IA.ULTRAGENYX PHARMACEUTICAL INC - ENROLLMENT IN PHASE 1/2 STUDY OF DTX401 TO BEGIN IN H1 2018, WITH DATA FROM FIRST COHORT EXPECTED IN H2 OF 2018.  Full Article

Ultragenyx Prices Public Offering Of 4.39 Mln Common Shares At $57/Share
Wednesday, 24 Jan 2018 

Jan 23 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX ANNOUNCES PRICING OF PUBLIC OFFERING OF COMMON STOCK.SAYS PUBLIC OFFERING OF 4.39 MILLION COMMON SHARES PRICED AT $57.00PER SHARE.  Full Article

Ultragenyx Announces Proposed Public Offering Of Common Stock
Tuesday, 23 Jan 2018 

Jan 22 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK.ULTRAGENYX PHARMACEUTICAL - COMMENCED PUBLIC OFFERING OF UP TO $175 MILLION SHARES OF ITS COMMON STOCK.  Full Article

Ultragenyx Announces Update To UX007 Development Program In Long-Chain Fatty Acid Oxidation Disorder Patients
Thursday, 4 Jan 2018 

Jan 4 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX ANNOUNCES UPDATE TO UX007 DEVELOPMENT PROGRAM IN LONG-CHAIN FATTY ACID OXIDATION DISORDER PATIENTS.ULTRAGENYX PHARMACEUTICAL INC - EXPECTS THAT DECISION ON A POTENTIAL FILING FOR APPROVAL BASED ON PHASE 2 DATA WILL BE MADE IN MID-2018.ULTRAGENYX PHARMACEUTICAL - SAFETY PROFILE WAS CONSISTENT WITH WHAT HAS BEEN PREVIOUSLY OBSERVED WITH UX007.  Full Article

Ultragenyx Sells Priority Review Voucher For $130 Mln
Monday, 18 Dec 2017 

Dec 18 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX SELLS PRIORITY REVIEW VOUCHER FOR $130 MILLION.ENTERED INTO A DEFINITIVE AGREEMENT TO SELL ITS RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER TO NOVARTIS.  Full Article

Ultragenyx And Kyowa Kirin Announce Burosumab Receives Positive CHMP Opinion For Treatment Of X-Linked Hypophosphatemia In Children
Friday, 15 Dec 2017 

Dec 15 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX AND KYOWA KIRIN ANNOUNCE BUROSUMAB RECEIVES POSITIVE CHMP OPINION FOR THE TREATMENT OF X-LINKED HYPOPHOSPHATEMIA IN CHILDREN.ULTRAGENYX PHARMA SAYS CHMP'S OPINION IS BEING REFERRED TO EC, FOR FINAL DECISION ON GRANT OF CONDITIONAL MARKETING AUTHORIZATION.ULTRAGENYX PHARMA SAYS DECISION ON GRANT OF CONDITIONAL MARKETING AUTHORIZATION IS EXPECTED IN Q1 2018.  Full Article

ULTRAGENYX SAYS FDA APPROVES MEPSEVII FOR GENETIC DISEASE MUCOPOLYSACCHARIDOSIS VII
Wednesday, 15 Nov 2017 

Nov 15 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX ANNOUNCES FDA APPROVAL OF MEPSEVII™ (VESTRONIDASE ALFA), THE FIRST THERAPY FOR PROGRESSIVE AND DEBILITATING RARE GENETIC DISEASE MUCOPOLYSACCHARIDOSIS VII.ULTRAGENYX PHARMACEUTICAL - OPINION FOR VESTRONIDASE ALFA FROM COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE IS EXPECTED IN H1 2018​.ULTRAGENYX PHARMACEUTICAL INC - ‍MEPSEVII WILL BE AVAILABLE TO PATIENTS IN U.S. LATER IN NOVEMBER​.  Full Article

FDA approves Ultragenyx Pharmaceutical's Mepsevii for rare genetic enzyme disorder‍​
Wednesday, 15 Nov 2017 

Nov 15 (Reuters) - FDA::Approved Ultragenyx Pharma's Mepsevii to treat pediatric, adult patients with inherited metabolic condition called mucopolysaccharidosis TYPE VII ‍​.  Full Article

Ultragenyx reports third quarter 2017 financial results
Friday, 3 Nov 2017 

Nov 2 (Reuters) - Ultragenyx Pharmaceutical Inc :Ultragenyx Pharmaceutical Inc- ‍cash, cash equivalents, and investments were $396.0 million as of September 30, 2017​.Q3 loss per share $1.87.Q3 earnings per share view $-1.86 -- Thomson Reuters I/B/E/S.  Full Article

ULTRAGENYX AND KYOWA HAKKO KIRIN ANNOUNCE FDA ACCEPTANCE OF BUROSUMAB’S BIOLOGICS LICENSE APPLICATION
Tuesday, 10 Oct 2017 

Oct 10 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX AND KYOWA HAKKO KIRIN ANNOUNCE FDA ACCEPTANCE AND PRIORITY REVIEW DESIGNATION OF BUROSUMAB’S BIOLOGICS LICENSE APPLICATION.ULTRAGENYX PHARMACEUTICAL INC - ‍PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE FOR BLA IS APRIL 17, 2018​.ULTRAGENYX PHARMACEUTICAL INC - FDA HAS NOT INFORMED COMPANIES WHETHER AN ADVISORY COMMITTEE MEETING TO DISCUSS APPLICATION WILL BE NEEDED​.ULTRAGENYX - FDA ACCEPTED BLA FOR BUROSUMAB TO TREAT PEDIATRIC, ADULT PATIENTS WITH X-LINKED HYPOPHOSPHATEMIA, GRANTED PRIORITY REVIEW STATUS​.  Full Article

BRIEF-Ultragenyx Pharmaceutical Q1 Earnings Per Share $0.62

* ULTRAGENYX REPORTS FIRST QUARTER 2018 FINANCIAL RESULTS AND CORPORATE UPDATE