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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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                          Top Deals by Deal Size (USD bn)

                          01

                          EPS
                          Not Confirmed
                          EPS
                          Not Confirmed

                          Details : Integrated analysis confirms statistically superior efficacy and safety of voclosporin in combination with MMF and steroids over standard-of-care.

                          Product Name : Lupkynis

                          Product Type : Peptide

                          Upfront Cash : Inapplicable

                          October 22, 2020

                          Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed

                          Therapeutic Area : Nephrology

                          Highest Development Status : Phase III

                          Sponsor : Otsuka Pharmaceutical

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          02

                          EPS
                          Not Confirmed
                          EPS
                          Not Confirmed

                          Details : Integrated analysis confirms addition of voclosporin to standard-of-care resulted in faster Renal Response compared to standard-of-care alone in lupus nephritis.

                          Product Name : Lupkynis

                          Product Type : Peptide

                          Upfront Cash : Inapplicable

                          September 11, 2020

                          Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed

                          Therapeutic Area : Nephrology

                          Highest Development Status : Phase III

                          Sponsor : Otsuka Pharmaceutical

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          03

                          EPS
                          Not Confirmed
                          EPS
                          Not Confirmed

                          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.

                          Product Name : Lupkynis

                          Product Type : Peptide

                          Upfront Cash : Inapplicable

                          September 06, 2020

                          Lead Product(s) : Voclosporin

                          Therapeutic Area : Nephrology

                          Highest Development Status : Phase III

                          Sponsor : Otsuka Pharmaceutical

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          04

                          EPS
                          Not Confirmed
                          EPS
                          Not Confirmed

                          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.

                          Product Name : Lupkynis

                          Product Type : Peptide

                          Upfront Cash : Undisclosed

                          July 27, 2020

                          Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed

                          Therapeutic Area : Nephrology

                          Highest Development Status : Phase III

                          Sponsor : Jefferies

                          Deal Size : $200.0 million

                          Deal Type : Public Offering

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                          05

                          EPS
                          Not Confirmed
                          EPS
                          Not Confirmed

                          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.

                          Product Name : Lupkynis

                          Product Type : Peptide

                          Upfront Cash : Inapplicable

                          July 22, 2020

                          Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed

                          Therapeutic Area : Nephrology

                          Highest Development Status : Phase III

                          Sponsor : Otsuka Pharmaceutical

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          06

                          EPS
                          Not Confirmed
                          EPS
                          Not Confirmed

                          Details : The presented data demonstrated clinically meaningful benefits of voclosporin for trial participants across ethnicities and self-reported race.

                          Product Name : Lupkynis

                          Product Type : Peptide

                          Upfront Cash : Inapplicable

                          May 06, 2020

                          Lead Product(s) : Voclosporin

                          Therapeutic Area : Nephrology

                          Highest Development Status : Phase III

                          Sponsor : Otsuka Pharmaceutical

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          07

                          EPS
                          Not Confirmed
                          EPS
                          Not Confirmed

                          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.

                          Product Name : Lupkynis

                          Product Type : Peptide

                          Upfront Cash : Inapplicable

                          March 18, 2020

                          Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed

                          Therapeutic Area : Nephrology

                          Highest Development Status : Phase III

                          Sponsor : Otsuka Pharmaceutical

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          08

                          EPS
                          Not Confirmed
                          EPS
                          Not Confirmed

                          Details : The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis.

                          Product Name : Lupkynis

                          Product Type : Peptide

                          Upfront Cash : Inapplicable

                          March 16, 2020

                          Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed

                          Therapeutic Area : Nephrology

                          Highest Development Status : Phase III

                          Sponsor : Otsuka Pharmaceutical

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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