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Orphazyme A/S (ORPHA.CO)

ORPHA.CO on Copenhagen Stock Exchange

57.00DKK
23 Sep 2019
Change (% chg)

kr.-1.80 (-3.06%)
Prev Close
kr.58.80
Open
kr.58.80
Day's High
kr.58.80
Day's Low
kr.57.00
Volume
18,424
Avg. Vol
15,785
52-wk High
kr.75.80
52-wk Low
kr.41.10

Latest Key Developments (Source: Significant Developments)

Orphazyme H1 Net Loss Dkk 164 Million
Wednesday, 28 Aug 2019 

Aug 28 (Reuters) - Orphazyme A/S ::REG-ORPHAZYME ANNOUNCES INTERIM REPORT FIRST HALF 2019.ORPHAZYME MAINTAINS 2019 OPERATING LOSS OUTLOOK IN RANGE OF DKK 315-345 MILLION.H1 NET LOSS DKK 164 MILLION VERSUS LOSS DKK 108 MILLION YEAR AGO.WE WILL BE INTRODUCING AN EARLY ACCESS PROGRAM FOR NPC DURING FALL.ANTICIPATED CASH POSITION AT YEAR-END 2019 TO BE GREATER THAN DKK >110 MILLION.WE ARE ON TRACK TO FILE FOR OUR FIRST MARKETING AUTHORIZATION DURING H1 2020 AND CONTINUE OUR PREPARATIONS FOR LAUNCH OF ARIMOCLOMOL IN KEY MARKETS.WE LOOK FORWARD TO REPORTING HEADLINE RESULTS FROM TRIALS DURING FIRST HALF OF 2021.WE HAVE COMPLETED ENROLLMENT IN OUR PHASE 2 GAUCHER DISEASE TRIAL AND RESULTS ARE NOW EXPECTED IN H1 2020.  Full Article

Orphazyme Enters Into Loan Agreement With Kreos Capital VI (UK) Limited To Secure Funding Of EUR 9 Mln
Wednesday, 28 Aug 2019 

Aug 27 (Reuters) - Orphazyme A/S ::ORPHAZYME STRENGTHENS BALANCE SHEET WITH EUR 9 MILLION FINANCING FROM KREOS CAPITAL.PROCEEDS FROM LOAN WILL BE USED TO FUND ON-GOING PREPARATIONS FOR FILING OF ARIMOCLOMOL IN US AND EUROPE, COMMERCIAL PLANNING.PLANS TO DRAW DOWN LOAN ON SEPTEMBER 1, 2019.  Full Article

Orphazyme Prepares To File Arimoclomol In US For Niemann-Pick Disease Type C
Monday, 22 Jul 2019 

July 22 (Reuters) - Orphazyme A/S ::SAID ON SUNDAY PREPARES FOR FILING OF ARIMOCLOMOL IN US FOR NIEMANN-PICK DISEASE TYPE C (NPC).HAD POSITIVE MEETING WITH FDA AND REMAINS ON TRACK TO SUBMIT NEW DRUG APPLICATION FOR ARIMOCLOMOL FOR NPC IN H1 2020.PLANS TO INTRODUCE AN EARLY ACCESS PROGRAM FOR NPC IN THE FALL OF 2019.  Full Article

Orphazyme Appoints Kim Stratton As CEO
Monday, 15 Jul 2019 

July 15 (Reuters) - Orphazyme A/S ::REG-ORPHAZYME APPOINTS KIM STRATTON AS CHIEF EXECUTIVE OFFICER.KIM STRATTON WILL TAKE UP HER NEW POSITION ON OCTOBER 1, 2019.  Full Article

Orphazyme: GFD Investments LLC Buys 9,600 Shares At DKK 48,9/Shr
Tuesday, 5 Mar 2019 

March 5 (Reuters) - Orphazyme A/S ::REG-REPORTING OF TRANSACTIONS IN ORPHAZYME’S SHARES MADE BY PERSONS DISCHARGING MANAGERIAL RESPONSIBILITIES.GFD INVESTMENTS LLC BUYS 9,600 SHARES IN CO WITH VALUE OF DKK 48,9 PER SHARE.  Full Article

Orphazyme FY Operating Loss Widens To DKK 231.7 Million
Friday, 1 Mar 2019 

March 1 (Reuters) - Orphazyme A/S ::REG-ORPHAZYME ANNOUNCES ANNUAL REPORT 2018.FY OPERATING LOSS DKK 231.7 MILLION VERSUS LOSS DKK 131.0 MILLION YEAR AGO.AT YEAR-END 2019, WE ANTICIPATE A CASH POSITION OF DKK >50 MILLION COMPARED TO DKK 394.7 MILLION AS OF DECEMBER 31, 2018..2019 GUIDANCE: OPERATING LOSS DKK 315 MILLION - 345 MILLION.ORPHAZYME - FOR FY ENDING DECEMBER 31, 2019, ORPHAZYME EXPECTS TO INCUR SUBSTANTIAL COSTS ASSOCIATED WITH CLINICAL TRIALS AND FILING ACTIVITIES..ORPHAZYME - AS OF THE DATE HEREOF, THE COMPANY DOES NOT EXPECT TO MAKE DIVIDEND PAYMENTS WITHIN THE FORESEEABLE FUTURE..  Full Article

CytRx Corp Highlights Positive Results From Phase 2/3 Clinical Trial In Niemann Pick Disease Type C (Npc)
Wednesday, 6 Feb 2019 

Feb 6 (Reuters) - CytRx Corp ::CYTRX CORPORATION HIGHLIGHTS POSITIVE RESULTS FROM FULL DATA SET OF PHASE 2/3 CLINICAL TRIAL IN NIEMANN PICK DISEASE TYPE C (NPC) CONDUCTED BY ARIMOCLOMOL LICENSEE ORPHAZYME A/S.CYTRX CORP - CYTRX ELIGIBLE TO RECEIVE UP TO $120 MILLION IN FUTURE MILESTONES, PLUS ROYALTIES, FROM ARIMOCLOMOL LICENSING AGREEMENT.CYTRX CORP - ORPHAZYME TO ENGAGE WITH FDA AND EMA ON PATH TO APPROVAL WHILE PREPARING FOR FILING.CYTRX CORP - ORPHAZYME COMMUNICATED THAT IT PLANS TO SUBMIT REGULATORY FILING TO FDA AND EMA DURING FIRST HALF OF 2020.CYTRX CORP - IN FULL DATA SET ANALYSIS, TREATMENT WITH ARIMOCLOMOL ADJUNCT TO ROUTINE CLINICAL CARE RESULTED IN A 74% REDUCTION IN DISEASE PROGRESSION.  Full Article

Orphazyme says Novo Holdings Holds Total 3 Mln Shares In Co
Thursday, 31 Jan 2019 

Jan 30 (Reuters) - Orphazyme A/S ::REG-MAJOR SHAREHOLDER ANNOUNCEMENT.NOVO HOLDINGS A/S HOLDS TOTAL OF 3 MILLION SHARES IN COMPANY, CORRESPONDING TO 14.97% OF SHARE CAPITAL AND VOTING RIGHTS IN CO.  Full Article

Orphazyme Reports Positive Results From Full Data Set Of Phase II/III Arimoclomol Trial In NPC
Wednesday, 30 Jan 2019 

Jan 30 (Reuters) - Orphazyme A/S ::REG-ORPHAZYME REPORTS POSITIVE RESULTS FROM FULL DATA SET OF PHASE II/III ARIMOCLOMOL TRIAL IN NIEMANN-PICK DISEASE TYPE C (NPC).BIOMARKER RESULTS DEMONSTRATE STATISTICALLY SIGNIFICANT BIOLOGICAL RESPONSE TO TREATMENT.ORPHAZYME TO ENGAGE WITH FDA AND EMA ON PATH TO APPROVAL WHILE PREPARING FOR FILING.PRIMARY ENDPOINT SHOWS 74% REDUCTION IN DISEASE PROGRESSION AFTER 12 MONTHS COMPARED TO PLACEBO CONTROL (P-VALUE =0.0506).ORPHAZYME PLANS FOR SUBMISSION OF FILING IN US AND EU IN H1 2020, WITH POTENTIAL APPROVAL IN H2 2020..24-MONTH DATA IS EXPECTED TO BECOME AVAILABLE FROM ON-GOING OPEN-LABEL EXTENSION OF TRIAL IN Q3 2019.TREATMENT RESPONSE DEFINED AS NO CHANGE OR IMPROVED ON GLOBAL IMPRESSION OF IMPROVEMENT SCALE INCLUDED AS CO-PRIMARY ENDPOINT."WE WILL IMMEDIATELY INITIATE FILING PREPARATIONS AND SEEK TO MEET WITH FDA AND EMA MID-2019" - CEO.PLANS FOR SUBMISSION OF FILING IN US AND EU IN H1 2020, WITH POTENTIAL APPROVAL IN H2 2020.  Full Article

Orphazyme Reports Encouraging Arimoclomol Clinical Trial Top-Line Data In Niemann-Pick Disease Type C
Friday, 28 Sep 2018 

Sept 28 (Reuters) - Orphazyme A/S ::REG-ORPHAZYME REPORTS ENCOURAGING ARIMOCLOMOL CLINICAL TRIAL TOP-LINE DATA IN NIEMANN-PICK DISEASE TYPE C (NPC).ARIMOCLOMOL WAS WELL-TOLERATED IN PATIENTS WITH RARE DISEASE NPC.FULL DATA SET, INCLUDING BIOMARKER DATA, WILL BECOME AVAILABLE AND BE ANALYZED IN Q4 2018.24-MONTH DATA WILL BECOME AVAILABLE FROM ON-GOING OPEN-LABEL EXTENSION TRIAL IN Q2 2019..NPC PHASE II/III TRIAL TOP-LINE RESULTS SHOW TREATMENT BENEFIT OF ARIMOCLOMOL OVER PLACEBO ON PRIMARY ENDPOINT 5-DOMAIN NPC CLINICAL SEVERITY SCALE.SAYS STATISTICAL SIGNIFICANCE OF 0.05 WAS NOT REACHED.THIS COMPANY ANNOUNCEMENT DOES NOT IMPACT 2018 FINANCIAL GUIDANCE.  Full Article

BRIEF-Orphazyme Prepares To File Acrimoclomol In Europe For Niemann-Pick Disease Type C

* CONFIRMS ITS INTENTION TO FILE THE MARKETING AUTHORIZATION APPLICATION FOR NIEMANN-PICK DISEASE TYPE C IN H1 2020