Orphazyme provides regulatory update following Type A meeting with FDA on arimoclomol in Niemann-Pick disease type C
Oct 31, 2021
Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today provides an update on the regulatory status in the United States of its investigational product arimoclomol for Niemann-Pick disease type C (NPC) following a recently held Type A meeting with the U.S. Food and Drug Administration (FDA).
Orphazyme provides regulatory update following Type A meeting with FDA on arimoclomol in NPC
Read moreModified long-term share-based incentive program for 2021
Oct 7, 2021
Orphazyme A/S (ORPHA.CO (DK); ORPH (US)), a late-stage biopharmaceutical company, has today introduced a modified long-term incentive program for 2021 (the “LTIP”) with the view to retaining members of the Executive Management and other employees of the Group, while also creating an incentive for a positive share price development and corporate performance for the benefit of the Company’s shareholders.
Modified long term share based incentive program for 2021
Read moreOrphazyme provides regulatory and financial updates
Oct 5, 2021
Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today announces regulatory updates for its investigational drug candidate, arimoclomol, for which it is seeking marketing authorization in both Europe and the United States for the treatment of Niemann-Pick disease Type C (NPC). The company also announces that it now expects to end 2021 with a cash position of no less than DKK 80 million compared to prior guidance of approximately DKK 50 million.
Orphazyme provides regulatory and financial updates
Read moreOrphazyme reports business highlights and financial results in Interim Report First Half 2021
Aug 31, 2021
Orphazyme A/S (ORPHA.CO; ORPH) (“the Company”), a late-stage biopharmaceutical company, today announces its Interim Report First Half 2021 for the period January 1 – June 30, 2021.
Orphazyme reports business highlights and financial results in Interim Report First Half 2021
Read moreOrphazyme to host Interim Report First Half 2021 investor call on August 31, 2021
Aug 25, 2021
Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today announces that the Company will host an investor call during which Management will present the Interim Report First Half 2021. The presentation will be followed by a Q&A session.
Orphazyme to host interim report first half 2021 inv
Read moreOrphazyme announces publication of results from its Phase 2/3 trial of arimoclomol in Niemann-Pick disease type C in the Journal of Inherited Metabolic Disease
Aug 23, 2021
Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today announced that results from a Phase 2/3 trial of arimoclomol, an investigational heat-shock protein amplifier, in Niemann-Pick disease type C (NPC) have been published in the peer-reviewed Journal of Inherited Metabolic Disease (JIMD). The online publication is available here.
Orphazyme announces publication of results from its
Read moreNew publication date for Orphazyme’s Interim Report H1 2021
Aug 5, 2021
Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company, today announced a new publication date for Orphazyme’s Interim Report H1 2021, which is now being made public on August 31, 2021 (previously: August 24, 2021).
New publication date for Orphazyme’s Interim Report H1 2021
Read moreOrphazyme 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
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