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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 Reports Q4 Loss Per Share $1.89
Tuesday, 20 Feb 2018 04:05pm EST 

Feb 20 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX REPORTS FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS AND CORPORATE UPDATE.Q4 LOSS PER SHARE $1.89.  Full Article

Ultragenyx Announces Update To UX007 Development Program In Long-Chain Fatty Acid Oxidation Disorder Patients
Thursday, 4 Jan 2018 09:08am EST 

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 08:30am EST 

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 08:30am EST 

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 01:22pm EST 

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 11:55am EST 

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 04:05pm EDT 

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 08:30am EDT 

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

Dimension Therapeutics says on termination of merger with Ultragenyx co will be required to pay Ultragenyx a termination fee of $2.9 mln-SEC filing
Tuesday, 3 Oct 2017 08:59am EDT 

Oct 3 (Reuters) - Dimension Therapeutics Inc ::Dimension Therapeutics says on termination of merger with Ultragenyx co will be required to pay Ultragenyx a termination fee of $2.9 million-SEC filing.Dimension Therapeutics-co to reimburse Ultragenyx for $2.9 million fee paid by Ultragenyx on behalf of dimension for termination of Regenxbio deal.  Full Article

Ultragenyx to acquire Dimension Therapeutics
Tuesday, 3 Oct 2017 08:30am EDT 

Oct 3 (Reuters) - Ultragenyx Pharmaceutical Inc : :Ultragenyx to acquire Dimension Therapeutics.Ultragenyx Pharmaceutical Inc - deal for ‍$6.00 per share​.Ultragenyx Pharmaceutical Inc - deal for ‍approximately $151 million in cash​.Ultragenyx Pharmaceutical Inc - ‍transaction is structured as a tender offer and will be funded through ultragenyx's existing cash resources​.Ultragenyx Pharmaceutical Inc - ‍ultragenyx will pay regenxbio a termination fee pursuant to regenxbio merger agreement, on behalf of dimension​.Ultragenyx Pharmaceutical Inc - tender offer is not subject to a financing condition.  Full Article

BRIEF-Ultragenyx Reports Q4 Loss Per Share $1.89

* ULTRAGENYX REPORTS FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS AND CORPORATE UPDATE