Selskabsmeddelelser

Orphazyme announces confidential submission of a draft registration statement for a potential registered public offering in the United States

Jul 1, 2020

Orphazyme A/S (ORPHA.CO) (the “Company”), a late-stage biopharmaceutical company harnessing the amplification of the Heat-Shock Proteins in order to develop and commercialize novel therapeutics for the treatment of neurodegenerative orphan diseases, today announced that it has confidentially submitted a draft registration statement on Form F-1 to the U.S. Securities and Exchange Commission (“SEC”) relating to a potential registered public offering of the Company’s ordinary shares, in the form of American Depositary Shares (“ADSs”), in the United States. The draft registration statement is subject to ongoing review by the SEC, and the proposed listing of ADSs representing the Company's ordinary shares is subject to approval for listing on the Nasdaq Global Market. The Company's ordinary shares will continue to be admitted for trading on Nasdaq Copenhagen. Any potential offering is subject to market and other conditions, including board approval.  

Orphazyme announces confidential submission

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Orphazyme phase 2 study of arimoclomol in Gaucher disease demonstrates marked improvements in key clinical markers

Jun 24, 2020

Orphazyme A/S (ORPHA.CO), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today announces topline results from a 6-month phase 2 dose-finding study in Gaucher disease with arimoclomol, an investigational Heat-Shock Protein (HSP) amplifier. The data show a dose-dependent effect of arimoclomol on certain disease-relevant clinical secondary endpoints, such as liver and spleen size. Furthermore, the data demonstrate sustained levels of arimoclomol in the cerebrospinal fluid (CSF), providing further evidence of arimoclomol’s ability to cross the blood-brain barrier.

Orphazyme phase 2 study of arimoclomol

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Major shareholder announcement

May 29, 2020

Orphazyme A/S (ORPHA.CO), a 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 Novo Holdings A/S informing that Novo Holdings A/S as of today holds shares corresponding to less than 5% of the total share capital and total voting rights of the Company. Novo Holdings A/S is wholly-owned by the Novo Nordisk Foundation.

Major shareholder announcement

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Orphazyme initiates rolling submission of New Drug Application for arimoclomol with US FDA in Niemann-Pick disease Type C

May 29, 2020

Orphazyme A/S (ORPHA.CO), a biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today announces it has initiated the submission of its New Drug Application (NDA) for a rolling review by the US Food and Drug Administration (FDA) for arimoclomol, an investigational Heat-Shock Protein amplifier, for the treatment of Niemann-Pick disease Type C (NPC).

Orphazyme initiates rolling submission of new drug

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Capital increase of 1,927 shares in Orphazyme A/S as a result of the exercise of Restricted Share Units

May 23, 2020

Orphazyme A/S (ORPHA.CO), a biopharmaceutical company pioneering Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today 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 1,927 shares of nominally DKK 1 each have been issued by the Company.

Capital increase of 1927 shares in Orphazyme

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Reporting of transactions in Orphazyme’s shares made by persons discharging managerial responsibilities

May 22, 2020

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

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Orphazyme’s arimoclomol receives US Fast Track Designation in Amyotrophic Lateral Sclerosis

May 22, 2020

Orphazyme A/S (ORPHA.CO), a biopharmaceutical company pioneering Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, announces that the Company has received Fast Track Designation from the US Food and Drug Administration (FDA) for the development of arimoclomol for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Orphazymes arimoclomol receives us fast track design

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Capital increase of 4,616 shares in Orphazyme A/S as a result of the exercise of Restricted Share Units

Apr 20, 2020

Orphazyme A/S (ORPHA.CO), a biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today announced 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 4,616 shares of nominally DKK 1 each have been issued by the Company.

Capital increase of 4616 shares in Orphazyme

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Reporting of transactions in Orphazyme’s shares made by persons discharging managerial responsibilities

Apr 17, 2020

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

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Resolutions passed at the Annual General Meeting

Mar 26, 2020

Orphazyme A/S (ORPHA.CO), a biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today held its Annual General Meeting, at which the Annual General Meeting.

Resolutions passed at the annual general meeting

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