Selskabsmeddelelser

Orphazyme provides regulatory update on arimoclomol for NPC

Dec 26, 2020

Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, announced today the U.S. Food and Drug Administration (FDA) has extended the review period of the New Drug Application (NDA) for arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC) by a standard extension period of three months. This extension is necessary for the FDA to complete its review. The updated Prescription Drug User Fee Act (PDUFA) target action date is June 17, 2021. 

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Kim Stratton, CEO, resigns from Orphazyme

Dec 10, 2020

Orphazyme A/S (ORPHA.CO) (“Orphazyme”), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today announces that Kim Stratton has decided to resign from Orphazyme following a dialogue initiated by the board of directors. Orphazyme will initiate a search for a new CEO immediately. Meanwhile, in order to ensure continuity going forward, Georges Gemayel, Chairman of the Board of Directors, will temporarily assist the executive team of Orphazyme with the day-to-day operations until a new CEO is appointed.

Kim Stratton ceo resigns from Orphazyme

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Financial calendar 2021

Dec 9, 2020

Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today announces that the company expects to publish financial reports according to the following schedule.

Financial calendar 2021

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Orphazyme establishes U.S. headquarters in Chicago as the company prepares for commercialization

Dec 2, 2020

Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today announced it has established its U.S. headquarters in Chicago.

Orphazyme establishes u s headquarters in chicago

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Orphazyme submits European Marketing Authorisation Application for arimoclomol for treatment of Niemann-Pick disease Type C

Nov 9, 2020

Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today announces it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for its investigational product candidate arimoclomol for the treatment of Niemann-Pick disease Type C (NPC).

Orphazyme submits european maa for arimoclomol

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End of stabilization period

Nov 3, 2020

With reference to company announcement no. 56/2020 dated September 29, 2020 regarding beginning of the stabilization period following the global offering (the “Global Offering”), consisting of an initial public offering of American Depositary Shares (the “ADSs”), each such ADS representing one ordinary share of Orphazyme, in the United States (the "U.S. Offering"), and a concurrent private placement of ordinary shares in Europe traded on Nasdaq Copenhagen A/S under the symbol “ORPHA” (the “European Private Placement”), Orphazyme A/S ("Orphazyme") has received notification that BofA Securities, Inc., who is acting as stabilizing manager in the Global Offering, that the stabilization period has ended and that (i) stabilization measures have been taken between September 29, 2020 and October 28, 2020 as set out in the attached end of stabilization notification from BofA Securities, Inc., given on its and its affiliate, BofA Securities Europe SA, behalf to Orphazyme, with respect to the ADSs admitted to trading on the Nasdaq Global Select Market in the United States under the symbol “ORPH”; (ii) no stabilization transactions have been taken in the ordinary shares of Orphazyme admitted to trading on Nasdaq Copenhagen A/S during the stabilization period; and (iii) the stabilization measures with respect to the ADSs set out in the attached mid-stabilization notification have been taken.

End of stabilization period

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Stabilization measures taken

Oct 27, 2020

With reference to company announcement no. 56/2020 dated September 29, 2020 regarding beginning of the stabilization period following the global offering (the “Global Offering”), consisting of an initial public offering of American Depositary Shares (the “ADSs”), each such ADS representing one ordinary share (the “Ordinary Shares”), in the United States (the "U.S. Offering"), and a concurrent private placement of Ordinary Shares in Europe (the “European Private Placement”), Orphazyme A/S ("Orphazyme") has received notification from  BofA Securities, Inc., who is acting as stabilizing manager in the Global Offering, that the stabilization measures set out in the attached notification have been taken. Reference is made to the attached notification from BofA Securities, Inc., given on its and its affiliate, BofA Securities Europe SA, behalf to Orphazyme, with respect to the ADSs of Orphazyme traded on the Nasdaq Global Select Market in the United States and the Ordinary Shares of Orphazyme traded on Nasdaq Copenhagen A/S, respectively.

Stabilization measures taken

Attachments notification from bofa securities inc

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Orphazyme accelerates arimoclomol pre-launch activities and updates financial outlook for 2020

Oct 23, 2020

Orphazyme A/S (ORPHA.CO), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein (HSP) response for the treatment of neurodegenerative orphan diseases, today announces an update to its financial outlook for 2020. The update is primarily driven by an acceleration in commercial and other pre-launch activities during the fourth quarter of 2020 in preparation for potential approval of its investigational product candidate arimoclomol in Niemann-Pick disease Type C (NPC), which is currently under Priority Review by the U.S. Food and Drug Administration (FDA) with a target action date of March 17, 2021.

Orphazyme accelerates arimoclomol

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Stabilization measures taken

Oct 16, 2020

With reference to company announcement no. 56/2020 dated September 29, 2020 regarding beginning of the stabilization period following the global offering (the “Global Offering”), consisting of an initial public offering of American Depositary Shares (the “ADSs”), each such ADS representing one ordinary share (the “Ordinary Shares”), in the United States (the "U.S. Offering"), and a concurrent private placement of Ordinary Shares in Europe (the “European Private Placement”), Orphazyme A/S ("Orphazyme") has received notification from  BofA Securities, Inc., who is acting as stabilizing manager in the Global Offering, that the stabilization measures set out in the attached notification have been taken. Reference is made to the attached notification from BofA Securities, Inc., given on its and its affiliate, BofA Securities Europe SA, behalf to Orphazyme, with respect to the ADSs of Orphazyme traded on the Nasdaq Global Select Market in the United States and the Ordinary Shares of Orphazyme traded on Nasdaq Copenhagen A/S, respectively.

Stabilization measures taken

Attachments notification from bofa securities inc v2

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Major shareholder announcement

Oct 9, 2020

Orphazyme A/S (ORPHA.CO) (“Orphazyme”), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, hereby announces the receipt of notification pursuant to Section 38 of the Danish Capital Markets Act from Danske Bank A/S that as of October 8, 2020, Danske Bank A/S holds a total of 1,346,609 shares in Orphazyme, corresponding to 3.88% of the share capital and that Danske Bank A/S as of October 8, 2020 controls 5.47% of the voting rights in Orphazyme.

Major shareholder announcement

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