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Ascendis Pharma A/S (ASND.OQ)

ASND.OQ on NASDAQ Stock Exchange Global Select Market

164.52USD
27 Nov 2020
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Latest Key Developments (Source: Significant Developments)

Ascendis Pharma Submits Marketing Authorisation Application For Transcon Hgh
Wednesday, 9 Sep 2020 

Sept 8 (Reuters) - Ascendis Pharma A/S ::ASCENDIS PHARMA A/S SUBMITS MARKETING AUTHORISATION APPLICATION (MAA) TO THE EUROPEAN MEDICINES AGENCY (EMA) FOR TRANSCON™ HGH FOR TREATMENT OF PEDIATRIC GROWTH HORMONE DEFICIENCY.ASCENDIS PHARMA A/S - MAA SUBMISSION INCLUDES DATA FROM CLINICAL DEVELOPMENT PROGRAM FOR TRANSCON HGH.ASCENDIS PHARMA A/S - BLA FOR TRANSCON HGH FOR TREATMENT FOR PEDIATRIC GHD IS UNDER REVIEW BY FDA, AND A PDUFA DATE IS SET FOR JUNE 25, 2021.  Full Article

Ascendis Pharma Says U.S. FDA Accepts Biologics License Application For Transcon HGH For Pediatric Growth Hormone Deficiency
Friday, 4 Sep 2020 

Sept 4 (Reuters) - Ascendis Pharma A/S ::ASCENDIS PHARMA A/S ANNOUNCES U.S. FOOD AND DRUG ADMINISTRATION (FDA) ACCEPTS BIOLOGICS LICENSE APPLICATION (BLA) FOR TRANSCON™ HGH FOR PEDIATRIC GROWTH HORMONE DEFICIENCY (GHD).ASCENDIS PHARMA A/S - FDA INDICATED THAT IT IS CURRENTLY NOT PLANNING TO HOLD AN ADVISORY COMMITTEE MEETING.ASCENDIS PHARMA A/S - PDUFA TARGET ACTION DATE OF JUNE 25, 2021 SET FOR TRANSCON HGH.  Full Article

Ascendis Pharma Announces Top-Line Data From Fixed Dose Portion Of Phase 2 Trial Demonstrating Potential Of Transcon PTH As Replacement Therapy For Hypoparathyroidism
Monday, 20 Apr 2020 

April 19 (Reuters) - Ascendis Pharma A/S ::ASCENDIS PHARMA A/S ANNOUNCES TOP-LINE DATA FROM FIXED DOSE PORTION OF PHASE 2 TRIAL DEMONSTRATING POTENTIAL OF TRANSCON™ PTH AS A REPLACEMENT THERAPY FOR HYPOPARATHYROIDISM.ASCENDIS PHARMA - PATH FORWARD TRIAL MET KEY OBJECTIVES, SHOWED TRANSCON PTH ELIMINATED STANDARD OF CARE IN 82 % OF SUBJECTS WITHIN FOUR WEEKS.ASCENDIS PHARMA A/S - PLANS TO ENGAGE WITH GLOBAL REGULATORY AUTHORITIES ON NEXT STEPS FOR DEVELOPMENT OF TRANSCON PTH,.ASCENDIS PHARMA A/S - PLANS TO SUBMIT REGULATORY FILINGS TO INITIATE A GLOBAL PHASE 3 TRIAL IN NORTH AMERICA, EUROPE AND ASIA IN Q4 OF 2020.  Full Article

Ascendis Pharma Expands Transcon PTH Phase 2 PaTH Forward Clinical Trial
Friday, 15 Nov 2019 

Nov 14 (Reuters) - Ascendis Pharma A/S ::ASCENDIS PHARMA EXPANDS TRANSCON™ PTH PHASE 2 PATH FORWARD CLINICAL TRIAL TO EXPEDITE ENROLLMENT OF SUBJECTS PREVIOUSLY TREATED WITH NATPARA® IN THE UNITED STATES.ASCENDIS PHARMA A/S - TOP-LINE DATA FROM EXPANDED PATH FORWARD TRIAL EXPECTED IN Q1 OF 2020.ASCENDIS PHARMA A/S - COMPANY EXPECTS TO EXCEED TARGETED ENROLLMENT OF 40 SUBJECTS.  Full Article

Ascendis Pharma A/S Reports Q1 Loss Per Share Of EUR 1.24
Friday, 31 May 2019 

May 30 (Reuters) - Ascendis Pharma A/S ::REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS.Q1 LOSS PER SHARE EUR 1.24.Q1 REVENUE EUR 5.4 MILLION.Q1 REVENUE ESTIMATE EUR 370,000 -- REFINITIV IBES DATA.Q1 EARNINGS PER SHARE ESTIMATE EUR -1.00 -- REFINITIV IBES DATA.AS OF MARCH 31, 2019, COMPANY HAD CASH AND CASH EQUIVALENTS OF EUR 696.7 MILLION COMPARED TO EUR 277.9 MILLION AS OF DECEMBER 31, 2018.  Full Article

Ascendis Pharma A/S Reports Full Year 2018 Financial Results
Thursday, 4 Apr 2019 

Ascendis Pharma A/S ::ASCENDIS PHARMA A/S REPORTS FULL YEAR 2018 FINANCIAL RESULTS.ASCENDIS PHARMA A/S - AS OF DEC 31, 2018, HAD CASH AND CASH EQUIVALENTS OF EUR 277.9 MILLION VERSUS EUR 195.4 MILLION IN PRIOR YEAR PERIOD.  Full Article

Ascendis Pharma Says Once-Weekly Transcon Growth Hormone Demonstrated Superiority On Primary Endpoint
Monday, 4 Mar 2019 

March 4 (Reuters) - Ascendis Pharma A/S ::ASCENDIS PHARMA ANNOUNCES ONCE-WEEKLY TRANSCON™ GROWTH HORMONE DEMONSTRATED SUPERIORITY ON PRIMARY ENDPOINT COMPARED TO A DAILY GROWTH HORMONE IN PHASE 3 HEIGHT TRIAL FOR PEDIATRIC GROWTH HORMONE DEFICIENCY.ASCENDIS PHARMA A/S - RESULTS FROM TRIAL INDICATE THAT TRANSCON HGH WAS GENERALLY SAFE AND WELL-TOLERATED.ASCENDIS PHARMA A/S - ASCENDIS PLANS A CLINICAL DATABASE LOCK FOR TRANSCON HGH PHASE 3 PROGRAM IN Q3 OF 2019.ASCENDIS PHARMA - TO SUBMIT BIOLOGICS LICENSE APPLICATION (BLA) WITH FDA FOR TRANSCON HGH TO TREAT PEDIATRIC GHD IN FIRST HALF OF 2020.  Full Article

Ascendis Pharma Expects Results From Phase 3 Trial Of Transcon HGH In Q1
Monday, 7 Jan 2019 

Jan 7 (Reuters) - Ascendis Pharma A/S ::ASCENDIS PHARMA A/S - TOP-LINE RESULTS FROM PHASE 3 HEIGHT TRIAL FOR TRANSCON HGH ARE EXPECTED IN Q1.ASCENDIS PHARMA A/S - TOP-LINE RESULTS FROM FLIGHT TRIAL (SWITCH) ARE EXPECTED IN Q2.ASCENDIS PHARMA A/S - TOP-LINE RESULTS FROM A PHASE 2 TRIAL FOR TRANSCON PTH ARE EXPECTED IN Q4.ASCENDIS PHARMA A/S - A PHASE 2 TRIAL OF TRANSCON CNP IN CHILDREN WITH ACHONDROPLASIA IS EXPECTED TO BE INITIATED IN Q3.ASCENDIS PHARMA A/S - HAS ESTABLISHED ONCOLOGY AS ITS SECOND INDEPENDENT THERAPEUTIC AREA.  Full Article