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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Lead Product(s): Daratumumab,Hyaluronidase,Cyclophosphamide

            Therapeutic Area: Genetic Disease Product Name: Darzalex

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Janssen Pharmaceutical

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 05, 2020

            Details:

            The submission is based on the Phase 3 ANDROMEDA study of daratumumab and hyaluronidase-fihj in combination with VCd as treatment for patients with newly diagnosed AL amyloidosis.

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            Lead Product(s): Arimoclomol

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 23, 2020

            Details:

            There are currently no approved products for NPC in the US and arimoclomol has the potential to make a significant difference to patients with this devastating disease.

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            Lead Product(s): Arimoclomol

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: CytRx

            Deal Size: $83.7 million Upfront Cash: Undisclosed

            Deal Type: Public Offering September 30, 2020

            Details:

            CytRx disclosed receipt of a filing communication from the U.S. Food and Drug Administration (“FDA”) relating to the agency’s ordinary course review of its new drug application for arimoclomol in the treatment of Niemann-Pick disease Type C.

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            Lead Product(s): Arimoclomol

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 16, 2020

            Details:

            If approved, arimoclomol would become the first approved therapy in the U.S. for people with Niemann-Pick disease Type C (NPC).

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            Lead Product(s): Concizumab

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 13, 2020

            Details:

            Novo Nordisk has together with relevant authorities identified a new path forward for concizumab. New safety measures and guidelines, based on analysis of all available data, have been agreed with the FDA and the clinical hold has been lifted.

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            Lead Product(s): Daratumumab,Cyclophosphamide,Dexamethasone

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 28, 2020

            Details:

            Phase III ANDROMEDA study of subcutaneous daratumumab in combination with cyclophosphamide, bortezomib and dexamethasone for patients with newly diagnosed light-chain (AL) amyloidosis met the primary endpoint of patients with hematologic complete response.