Orphazyme provides regulatory update from FDA on arimoclomol for Niemann-Pick disease type C
Jun 18, 2021
Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of rare diseases, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following its review of the new drug application for arimoclomol, a heat shock protein amplifier intended for the treatment of Niemann-Pick disease type C (NPC).
Orphazyme provides regulatory update from FDA on arimoclomol
Read moreMajor shareholder announcement
Jun 15, 2021
Orphazyme A/S (ORPHA.CO; ORPH) (“the Company”), a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of rare diseases, hereby announces the receipt of notification pursuant to Section 38 of the Danish Capital Markets Act from Sunstone Life Science Ventures A/S and Sunstone Life Science Ventures Fund II K/S, that as of June 11, 2021, Sunstone Life Science Ventures Fund II K/S holds less than 5% of the Company’s share capital and that Sunstone Life Science Ventures A/S as of June 11, 2021, controls less than 5% of the voting rights in the Company.
Major shareholder announcement 1
Read moreOrphazyme addresses recent trading activity
Jun 11, 2021
Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of rare diseases, today announced that American Depositary Shares (ADSs) representing its ordinary shares on Nasdaq US have since June 10, 2021 experienced extreme volatility in price and trading volume. The company is not aware of any material change in its clinical development programs, financial condition or results of operations that would explain such price volatility or trading volume that has occurred since June 10, 2021. Investors who purchase the company’s ADS or shares may lose a significant portion of their investments if the price of such securities subsequently declines.
Orphazyme addresses recent trading activity
Read moreOrphazyme announces topline data from pivotal trial of arimoclomol in Amyotrophic Lateral Sclerosis (ALS)
May 7, 2021
Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of rare diseases, today announced that the ORARIALS-01 pivotal trial of arimoclomol in amyotrophic lateral sclerosis (ALS) did not meet its primary and secondary endpoints to show benefit in people living with ALS. No important safety signals were reported in the trial. Topline data will be presented at the upcoming virtual European Network to Cure ALS (ENCALS) meeting, May 12-14, and complete data from the study will be published later this year.
Orphazyme announces topline data from pivotal trial of arimoclomol in ALS
Read moreOrphazyme to present at upcoming investor conferences
Apr 27, 2021
Orphazyme A/S [ORPHA.CO (DK); ORPH (US)], a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of neurodegenerative rare diseases, today announced that company management will be participating at the following virtual investor conferences:
Orphazyme to present at upcoming investor conferences
Read moreNew long-term share-based incentive program
Apr 22, 2021
Orphazyme A/S [ORPHA.CO (DK); ORPH (US)], a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of neurodegenerative rare diseases, has today introduced a new long-term incentive program (the “LTIP”).
New long-term share-based incentive program
Read moreOrphazyme announces topline results from pivotal trial of arimoclomol for Inclusion Body Myositis (IBM)
Mar 29, 2021
Orphazyme A/S [ORPHA.CO (DK); ORPH (US)], a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of neurodegenerative rare diseases, today announced its phase 2/3 trial evaluating arimoclomol for the treatment of inclusion body myositis (IBM), a progressively debilitating muscle-wasting disease, did not meet its primary and secondary endpoints. The primary goal was to evaluate the treatment effect on disease progression as measured by the inclusion body myositis functional rating scale (IBMFRS).
Read moreReporting of transactions in Orphazyme’s shares made by persons discharging managerial responsibilities
Mar 25, 2021
Pursuant to the Market Abuse Regulation article 19, Orphazyme A/S, CVR no. 32266355 (“Orphazyme”), hereby notifies receipt of information of the following transactions in Orphazyme’s shares by persons discharging managerial responsibilities in Orphazyme.
Read moreArticles of Association for Orphazyme A/S
Mar 25, 2021
Orphazyme A/S (ORPHA.CO; ORPH) (“the Company”), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today held its Annual General Meeting, at which amendments to the Articles of Association of the Company were adopted.
Orphazyme Vedtgter 25. marts 2021
Articles of Association for Orphazyme
Read moreCapital increase of 3,854 shares in Orphazyme A/S as a result of the exercise of Restricted Share Units
Mar 25, 2021
Orphazyme A/S (ORPHA.CO; ORPH) (“the Company”), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, announces that a share capital increase has been registered with the Danish Business Authority as a result of the exercise of Restricted Share Units by board members. A total of 3,854 shares of nominally DKK 1 each have been issued by the Company at a subscription price per Restricted Share Unit of DKK 61.1895.
Capital increase of 3854 shares in Orphazyme as a result of the exercise of Restricted Share Units
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