Drugs in Dev. Nephrology
Phase III
Canada 
Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Otsuka Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Otsuka Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurinia Presents Integrated Time to Renal Response Data from the AURA-LV and AURORA Trials
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
Lead Product(s) : Voclosporin
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Otsuka Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurinia Presents Additional AURORA Pivotal Trial Safety Data at the ERA-EDTA Virtual Congress 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.
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
Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Jefferies
Deal Size : $200.0 million
Deal Type : Public Offering
Aurinia Closes US$200 Million Public Offering of Common Shares
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
Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Otsuka Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Lead Product(s) : Voclosporin
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Otsuka Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurinia Presents AURORA Pivotal Trial Subgroup Analysis at the EULAR 2020 E-Congress
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
Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Otsuka Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurinia Announces AURORA Phase 3 Clinical Data for Voclosporin
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
Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Otsuka Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
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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