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Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: ISA247
Highest Development Status: Phase III Product Type: Peptide
Partner/Sponsor/Collaborator: Jefferies
Deal Size: $200.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 27, 2020
Details:
The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.
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Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Product Name: ISA247
Highest Development Status: Phase III Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2020
Details:
The FDA grants priority review designation to the evaluation of drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment for serious conditions.
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Lead Product(s): Voclosporin
Therapeutic Area: Nephrology 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 June 09, 2020
Details:
The data showed that pre-specified confirmed estimated glomerular filtration rate (eGFR) decreases of over 30% were similar in both AURORA trial patient groups, with 10.1% reported in the voclosporin group and 10.2% in the control arm.
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Lead Product(s): Voclosporin
Therapeutic Area: Nephrology 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 June 05, 2020
Details:
The presented data demonstrated clinically meaningful benefits of voclosporin for trial participants across ethnicities and self-reported race.
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Lead Product(s): Voclosporin,Mycophenolic Acid,Corticosteroids
Therapeutic Area: Nephrology 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 March 18, 2020
Details:
Clinical data from its AURORA Phase 3 trial will be highlighted in a late-breaking oral presentation during the National Kidney Foundation 2020 Spring Clinical Meetings.
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Lead Product(s): Voclosporin
Therapeutic Area: Nephrology 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 March 16, 2020
Details:
The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis.
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