Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  NASDAQ OMX COPENHAGEN  >  Orphazyme A/S    ORPHA   DK0060910917

ORPHAZYME A/S

(ORPHA)
  Report  
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsOfficial PublicationsSector news
The feature you requested does not exist. However, we suggest the following feature:

Orphazyme A/S : Phase II/III trial in sporadic Inclusion Body Myositis fully enrolled

share with twitter share with LinkedIn share with facebook
share via e-mail
0
04/23/2019 | 06:40am EDT

Orphazyme A/S
Company announcement                                                                                                                   

No. 13/2019                                                                                                                                       
Company Registration No. 32266355

 

  • Study completion expected by end 2020
  • Results expected in H1 2021


Copenhagen, April 23, 2019
– Orphazyme A/S (ticker: ORPHA.CO), a biopharmaceutical company dedicated to developing treatments for patients living with rare diseases, today announced that its Phase II/III trial of arimoclomol for the treatment of sporadic Inclusion Body Myositis (sIBM) is fully enrolled. Performance of interim analysis and study completion expected in H1 2020 and by end 2020, respectively. Results are expected in H1 2021.

Anders Hinsby, Chief Executive Officer, said: “We are truly delighted about the strong support for this trial from the patient community and clinicians, which has been paramount to achieving enrollment at an impressive rate. Sporadic Inclusion Body Myositis is a relentlessly progressive and debilitating disease with no current treatment options available and we cannot waste any time in completing this trial in order to evaluate the potential of arimoclomol as a treatment for this disease”.

The Phase II/III trial of arimoclomol for sIBM is a 150-patient, 20-month, randomized, double-blinded, placebo-controlled trial at 11 centers of excellence in the US and one in the UK. Orphazyme has initiated an open-label extension trial to which patients from the Phase II/III trial may enroll and continue treatment.

 

For additional information, please contact

Orphazyme A/S
Anders Hinsby, CEO                             +45 31 44 31 39

 

About Orphazyme A/S 
Orphazyme is a biopharmaceutical company focused on bringing novel treatments to patients living with life-threatening or debilitating rare diseases. Our research focuses on developing therapies for diseases caused by misfolding of proteins and lysosomal dysfunction. Arimoclomol, the company’s lead candidate, is in clinical development for four orphan diseases: Niemann-Pick disease Type C, Gaucher disease, sporadic Inclusion Body Myositis, and Amyotrophic Lateral Sclerosis. The Denmark-based company is listed on Nasdaq Copenhagen (ORPHA.CO). For more information, please visit www.orphazyme.com.

About sIBM 
Sporadic Inclusion Body Myositis (sIBM) is a progressively debilitating muscle-wasting disease. sIBM is characterized by a build-up of protein aggregates and atrophy of muscle cells, which leads to weakness and over time severe disability. The estimated prevalence of sIBM is 24.8-45.6 per million or 17,000-31,000 patients in the USA and Europe. There are no approved treatments for sIBM. Arimoclomol has been granted Orphan Drug Designation (EU and USA) for the treatment of sIBM.

Forward-looking statement
This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

 

Attachment

  • 13-2019 Orphazymes Phase II-III trial in sporadic Inclusion Body Myositis fully enrolled

© OMX, source OMX

share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on ORPHAZYME A/S
04/23ORPHAZYME A/S : Phase II/III trial in sporadic Inclusion Body Myositis fully enr..
AQ
04/17ORPHAZYME A/S : Major shareholder announcement
AQ
03/27ORPHAZYME A/S : Resolution passed at the Annual General Meeting
AQ
03/11ORPHAZYME A/S : to present at Cowen & Co Annual Health Care Conference
AQ
03/05ORPHAZYME A/S : Notice to convene Annual General Meeting
AQ
03/04ORPHAZYME A/S : Reporting of transactions in Orphazyme's shares made by persons ..
AQ
03/04REDEYE : Orphazyme - Summary of 2018, important year ahead
AQ
03/01ORPHAZYME A/S : announces Annual Report 2018
AQ
02/25ORPHAZYME A/S : Annual Report 2018 Presentation
AQ
02/08CYTRX CORPORATION : Highlights Positive Results from Full Data Set of Phase 2/3 ..
AQ
More news
Financials (DKK)
Sales 2019 -
EBIT 2019 -329 M
Net income 2019 -329 M
Finance 2019 94,3 M
Yield 2019 -
P/E ratio 2019 -
P/E ratio 2020
EV / Sales 2019 0
EV / Sales 2020 87,6x
Capitalization 1 059 M
Chart ORPHAZYME A/S
Duration : Period :
Orphazyme A/S Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends ORPHAZYME A/S
Short TermMid-TermLong Term
TrendsBearishNeutralBearish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 3
Average target price 117  DKK
Spread / Average Target 120%
EPS Revisions
Managers
NameTitle
Anders Mørkebjerg Hinsby Chief Executive Officer
Georges Gemayel Chairman
Anders Fink Vadsholt Chief Financial Officer
Thomas Kirkegaard Jensen Chief Scientific Officer
Thomas Blaettler Chief Medical Officer
Sector and Competitors
1st jan.Capitalization (M$)
ORPHAZYME A/S21.80%158
GILEAD SCIENCES6.35%83 745
VERTEX PHARMACEUTICALS2.06%42 447
REGENERON PHARMACEUTICALS-17.01%32 595
GENMAB12.27%10 632
SAREPTA THERAPEUTICS INC11.05%8 718