Orphazyme presents 36-month data supporting durable response to arimoclomol during Parseghian Scientific Conference for NPC Research
Jun 28, 2021
Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today announced 24-month interim results of an open-label extension (OLE) trial, providing efficacy and safety data for its investigational treatment arimoclomol in Niemann-Pick disease type C (NPC) for up to 36 months. The data are featured in a presentation as part of the Parseghian Scientific Conference for Niemann-Pick disease type C Research.
Orphazyme presents 36 month data supporting durable
Read moreOrphazyme announces restructuring to focus resources on supporting a path forward for arimoclomol in NPC
Jun 28, 2021
Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today announced a restructuring intended to enable the company to advance its corporate strategy and the development of arimoclomol for Niemann-Pick disease type C (NPC). The resulting cost savings include an approximate two thirds reduction in our global workforce. Orphazyme remains committed to pursuing regulatory approval in Europe and assessing a path forward for arimoclomol in the U.S. following receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on June 17, 2021.
Read moreMajor 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
Read moreMajor 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
Read moreOrphazyme 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
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