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Lead Product(s): Lenadogene nolparvovec
Therapeutic Area: Genetic Disease Product Name: Lumevoq
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2021
Details:
Journal of the American Academy of Ophthalmology, Ophthalmology®, has published results from the RESCUE pivotal Phase III clinical trial of LUMEVOQ® gene therapy in ND4 Leber Hereditary Optic Neuropathy (LHON) subjects.
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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: CytRx Corporation
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.
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