Posts by Michael Hove for News

Major shareholder announcement

Jun 24, 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 Aescap Venture Management B.V, that as of June 16, 2021, Aescap Venture Management B.V indirectly holds shares corresponding to less than 5% of the total share capital and voting rights in the Company.

Major shareholder announcement

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Major shareholder announcement

Jun 23, 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 notifications pursuant to Section 38 of the Danish Capital Markets Act from The Goldman Sachs Group, Inc., that as of June 16, 2021, The Goldman Sachs Group, Inc.’s aggregate holding of shares and financial instruments increased to 5.58% of the share capital and voting rights in the Company, and as of June 17, 2021, The Goldman Sachs Group, Inc.’s aggregate holding of shares and financial instruments has been reduced to less than 5% of the shares and voting rights in the Company.

Major shareholder announcement

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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

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Major 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

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Orphazyme 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

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Orphazyme 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

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Orphazyme 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

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New 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

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Orphazyme 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).

Orphazyme announces topline results from pivotal trial of arimoclomol for Inclusion Body Myositis IBM

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Reporting 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.

Reporting of transactions in Orphazymes shares made by persons discharging managerial responsibilities

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