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Ultragenyx Pharmaceutical Inc (RARE.OQ)

RARE.OQ on NASDAQ Stock Exchange Global Select Market

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20 Feb 2019
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Latest Key Developments (Source: Significant Developments)

Ultragenyx Announces Positive Topline Data From Ongoing Long-Term Extension Study Of Ux007
Tuesday, 22 Jan 2019 08:32am EST 

Jan 22 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX ANNOUNCES POSITIVE TOPLINE DATA FROM ONGOING LONG-TERM EXTENSION STUDY OF UX007 FOR THE TREATMENT OF LONG-CHAIN FATTY ACID OXIDATION DISORDERS.ULTRAGENYX PHARMACEUTICAL INC - COMPANY ON TRACK FOR MID-2019 NDA SUBMISSION.ULTRAGENYX PHARMACEUTICAL INC - ADDITIONAL 20 PATIENTS NAÏVE TO UX007 ALSO DEMONSTRATED MEANINGFUL REDUCTIONS IN MAJOR CLINICAL EVENTS WITH TREATMENT.ULTRAGENYX PHARMACEUTICAL INC - REDUCTIONS IN MAJOR CLINICAL EVENTS SUSTAINED AFTER AN ADDITIONAL 78 WEEKS OF UX007 TREATMENT.  Full Article

Ultragenyx Reports Positive Results From Phase 1/2 Study Of Dtx401 In Glycogen Storage Disease Type Ia
Friday, 4 Jan 2019 08:30am EST 

Jan 4 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX ANNOUNCES POSITIVE TOPLINE RESULTS FROM FIRST COHORT OF PHASE 1/2 CLINICAL STUDY OF DTX401 GENE THERAPY IN GLYCOGEN STORAGE DISEASE TYPE IA.ULTRAGENYX - DTX401 RESPONSE OBSERVED IN ALL THREE PATIENTS, WITH TWO PATIENTS DEMONSTRATING CLINICALLY MEANINGFUL IMPROVEMENT IN TIME TO HYPOGLYCEMIA.ULTRAGENYX PHARMACEUTICAL INC - PHASE 1/2 CLINICAL STUDY OF DTX401 TO ADVANCE TO COHORT 2 AT A HIGHER DOSE.  Full Article

Ultragenyx Announces Intent To Submit NDA To U.S. FDA For UX007
Wednesday, 14 Nov 2018 08:30am EST 

Nov 14 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX ANNOUNCES INTENT TO SUBMIT NEW DRUG APPLICATION TO U.S. FDA FOR UX007 FOR THE TREATMENT OF LONG-CHAIN FATTY ACID OXIDATION DISORDERS IN MID-2019.ULTRAGENYX PHARMACEUTICAL - PLANS TO SUBMIT A NDA TO FDA FOR UX007 FOR TREATMENT OF PATIENTS WITH LONG-CHAIN FATTY ACID OXIDATION DISORDERS IN MID-2019.  Full Article

Ultragenyx Reports Q3 Loss Per Share $1.74
Monday, 5 Nov 2018 04:05pm EST 

Nov 5 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS AND CORPORATE UPDATE.Q3 LOSS PER SHARE $1.74.Q3 EARNINGS PER SHARE VIEW $-1.96 -- THOMSON REUTERS I/B/E/S.Q3 REVENUE $11.8 MILLION VERSUS I/B/E/S VIEW $11.4 MILLION.  Full Article

Ultragenyx Announces Negative Topline Results From Phase 3 Study Of UX007
Friday, 26 Oct 2018 08:00am EDT 

Oct 26 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX ANNOUNCES NEGATIVE TOPLINE RESULTS FROM PHASE 3 STUDY OF UX007 IN PATIENTS WITH GLUT1 DS WITH DISABLING MOVEMENT DISORDERS.ULTRAGENYX PHARMACEUTICAL INC - ULTRAGENYX DISCONTINUING DEVELOPMENT OF UX007 IN GLUT1 DS INDICATION.ULTRAGENYX PHARMACEUTICAL INC - COMPANY ON TRACK WITH SEPARATE UX007 PROGRAM IN LC-FAOD WITH PRE-NDA MEETING LATER THIS YEAR.ULTRAGENYX PHARMACEUTICAL INC - STUDY ALSO DID NOT MEET ITS KEY SECONDARY ENDPOINTS.ULTRAGENYX PHARMACEUTICAL - WILL WORK WITH INVESTIGATORS AND PATIENTS ON REASONABLE TRANSITION PLAN FOR PATIENTS WITH GLUT1 DS WHO ARE STILL ON UX007.ULTRAGENYX PHARMACEUTICAL INC - PHASE 3 STUDY OF UX007 DID NOT ACHIEVE ITS PRIMARY ENDPOINT.ULTRAGENYX PHARMACEUTICAL INC - SAFETY PROFILE OBSERVED IN THE STUDY WAS CONSISTENT WITH WHAT HAS BEEN PREVIOUSLY REPORTED WITH UX007.  Full Article

Ultragenyx, Kyowa Kirin Say Crysvita Met Main Goal Of Phase 3 Study
Thursday, 17 May 2018 08:30am EDT 

May 17 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX AND KYOWA KIRIN ANNOUNCE TOPLINE PHASE 3 STUDY RESULTS DEMONSTRATING SUPERIORITY OF CRYSVITA® (BUROSUMAB) TREATMENT TO ORAL PHOSPHATE AND ACTIVE VITAMIN D IN CHILDREN WITH X-LINKED HYPOPHOSPHATEMIA (XLH).ULTRAGENYX PHARMACEUTICAL INC - PHASE 3 STUDY OF CRYSVITA® (BUROSUMAB) MET ITS PRIMARY ENDPOINT.ULTRAGENYX PHARMACEUTICAL - PHASE 3 STUDY OF CRYSVITA SHOWED IMPROVEMENT IN IMPORTANT METABOLIC AND FUNCTIONAL MEASURES WITH CRYSVITA TREATMENT.  Full Article

FDA Approves Ultragenyx Pharmaceutical's Crysvita To Treat An Inherited Form Of Rickets
Tuesday, 17 Apr 2018 01:28pm EDT 

April 17 (Reuters) - U.S. Food and Drug Administration::U.S. FDA SAYS APPROVED CRYSVITA (BUROSUMAB) TO TREAT ADULTS & CHILDREN AGES 1 YEAR & OLDER WITH X-LINKED HYPOPHOSPHATEMIA, AN INHERITED FORM OF RICKETS.U.S. FDA SAYS GRANTED APPROVAL OF CRYSVITA TO ULTRAGENYX PHARMACEUTICAL INC.  Full Article

Kyowa Kirin, Ultragenyx Announce Crysvita Receives Conditional Marketing Authorization In Europe For The Treatment Of X–Linked Hypophosphatemia In Children
Friday, 23 Feb 2018 08:00am EST 

Feb 23 (Reuters) - Ultragenyx Pharmaceutical Inc ::KYOWA KIRIN AND ULTRAGENYX ANNOUNCE CRYSVITA® (BUROSUMAB) RECEIVES CONDITIONAL MARKETING AUTHORIZATION IN EUROPE FOR THE TREATMENT OF X–LINKED HYPOPHOSPHATEMIA IN CHILDREN.ULTRAGENYX PHARMACEUTICAL - ‍FIRST COMMERCIAL LAUNCH OF CRYSVITA IS EXPECTED TO TAKE PLACE IN GERMANY IN Q2 OF 2018​.  Full Article

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