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Ultragenyx Pharmaceutical Inc (RARE.OQ)

RARE.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Ultragenyx Sells Priority Review Voucher For $130 Mln
1:30pm GMT 

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
Thursday, 2 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

Ultragenyx files for resale of upto 374,590 shares of co
Wednesday, 10 Aug 2016 

Ultragenyx Pharmaceutical :Files for resale of upto 374,590 shares of co by Takeda Pharma Co ltd/its pledgees, assignees/successor-in-interest.  Full Article

Ultragenyx Pharmaceutical reports Q2 loss $1.46/shr
Monday, 8 Aug 2016 

Ultragenyx Pharmaceutical Inc : Ultragenyx reports second quarter 2016 financial results and corporate update . Q2 shr loss $1.46 .Q2 shr view $-1.44 -- Thomson Reuters I/B/E/S.  Full Article

Ultragenyx Pharmaceutical files for stock shelf of upto $150 mln
Friday, 1 Jul 2016 

Ultragenyx Pharmaceutical Inc :Files for stock shelf of upto $150 million - SEC filing.  Full Article

Ultragenyx receives breakthrough therapy designation for KRN23
Tuesday, 28 Jun 2016 

Ultragenyx : Plans to initiate a phase 3 study of KRN23 in pediatric patients with XLH in mid-2016 . Phase 3 program of KRN23 in adult patients with XLH is ongoing .Receives Breakthrough Therapy Designation For KRN23 In Pediatric Patients With X Linked hypophosphatemia.  Full Article

BRIEF-Ultragenyx Sells Priority Review Voucher For $130 Mln

* ENTERED INTO A DEFINITIVE AGREEMENT TO SELL ITS RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER TO NOVARTIS Source text for Eikon: Further company coverage: