Genetic Disease | Phase II/ Phase III Developments | DENMARK

Orphazyme

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Orphazyme Completes Rolling Submission of New Drug Application to U.S. FDA for Arimoclomol for Niemann-Pick Disease Type C

Lead Product(s): Arimoclomol

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 20, 2020

Details:

Orphazyme has completed the rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational therapy arimoclomol for the treatment of Niemann-Pick disease Type C (NPC).

Orphazyme

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DENMARK Denmark

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Chinaplas 2020

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Orphazyme Initiates Rolling Submission Of New Drug Application For Arimoclomol With FDA in Niemann-Pick Disease Type C

Lead Product(s): Arimoclomol

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2020

Details:

Orphazyme has initiated the submission of its New Drug Application (NDA) for a rolling review by the US Food and Drug Administration (FDA) for arimoclomol, based on the promising results reported from clinical trials. Trial conducted in collaboration with CytRx Corporation.

Orphazyme

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DENMARK Denmark

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Orphazyme reports positive arimoclomol data from open-label phase 2/3 extension in Niemann-Pick disease Type C

Lead Product(s): Arimoclomol

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 03, 2020

Details:

Orphazyme expects to receive approval for NPC in H1 2021 in the US through the fast track approval process, with the aim to bring the product to patients shortly thereafter.

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Orphazyme

Orphazyme Completes Rolling Submission of New Drug Application to U.S. FDA for Arimoclomol for Niemann-Pick Disease Type C

Orphazyme

Orphazyme Initiates Rolling Submission Of New Drug Application For Arimoclomol With FDA in Niemann-Pick Disease Type C

Orphazyme

Orphazyme reports positive arimoclomol data from open-label phase 2/3 extension in Niemann-Pick disease Type C