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NEWS #PharmaBuzz
03 Nov 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20251103166461/en/Aurinia-Pharmaceuticals-to-Report-Financial-Results-for-the-Three-and-Nine-Months-Ended-September-30-2025-and-Provide-Update-on-Recent-Business-Progress-on-November-4-2025
15 Oct 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20251015580814/en/Aurinia-Announces-Upcoming-Presentations-of-New-Data-on-LUPKYNIS-at-American-College-of-Rheumatology-Convergence-and-American-Society-of-Nephrology-Kidney-Week-2025
30 Sep 2025
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/fdas-cder-chief-challenges-safety-efficacy-aurinias-lupus-med-deleted-linkedin-post
29 Sep 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250929618760/en/Aurinia-Responds-to-Now-Retracted-LinkedIn-Post
31 Jul 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250731800519/en/Aurinia-Pharmaceuticals-Reports-Financial-Results-for-the-Three-and-Six-Months-Ended-June-30-2025
22 Jul 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250722543875/en/Aurinia-Pharmaceuticals-to-Release-Second-Quarter-2025-Financial-and-Operational-Results-on-July-31-2025
Drugs in Development
Details:
Lupkynis (voclosporin) is an approved oral calcineurin inhibitor, a small molecule drug candidate, which is indicated for the treatment of patients with Lupus Nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Brand Name: Lupkynis
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 24, 2024
Lead Product(s) : Voclosporin
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurinia Announces Japan Approval of LUPKYNIS® (Voclosporin) to Treat Lupus Nephritis
Details : Lupkynis (voclosporin) is an approved oral calcineurin inhibitor, a small molecule drug candidate, which is indicated for the treatment of patients with Lupus Nephritis.
Product Name : Lupkynis
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
September 24, 2024
Details:
AUR200, a highly potent and specific immune modulator, is an IgG4 Fc-fusion protein, inhibits BAFF and APRIL, which is being investigated for autoimmune diseases.
Lead Product(s): AUR200
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 05, 2024
Lead Product(s) : AUR200
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurinia Announces First Participant Dosed in AUR200 Single Ascending Dose Trial
Details : AUR200, a highly potent and specific immune modulator, is an IgG4 Fc-fusion protein, inhibits BAFF and APRIL, which is being investigated for autoimmune diseases.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
September 05, 2024
Details:
Lupkynis (voclosporin) is a USFDA approved oral calcineurin inhibitor, small molecule drug candidate, which is indicated for the treatment of patients with Lupus Nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Brand Name: Lupkynis
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 30, 2024
Lead Product(s) : Voclosporin
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Updated LUPKYNIS® Label with Long-Term Data from AURORA Clinical Program
Details : Lupkynis (voclosporin) is a USFDA approved oral calcineurin inhibitor, small molecule drug candidate, which is indicated for the treatment of patients with Lupus Nephritis.
Product Name : Lupkynis
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
April 30, 2024
Details:
AUR200s a highly potent and specific Fc-fusion protein, which is a BAFF/APRIL inhibitor. Currently, it is being evaluated in the IND enabling studies for the treatment of autoimmune diseases such as IgA nephropathy and systemic lupus erythematosus.
Lead Product(s): AUR200
Therapeutic Area: Nephrology Brand Name: Undisclosed
Study Phase: IND EnablingProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 20, 2023
Lead Product(s) : AUR200
Therapeutic Area : Nephrology
Highest Development Status : IND Enabling
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurinia Submits IND Application to US Food & Drug Administration for AUR 200
Details : AUR200s a highly potent and specific Fc-fusion protein, which is a BAFF/APRIL inhibitor. Currently, it is being evaluated in the IND enabling studies for the treatment of autoimmune diseases such as IgA nephropathy and systemic lupus erythematosus.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
December 20, 2023
Details:
Lupkynis (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action. It is being developed for the treatment of lupus nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Brand Name: Lupkynis
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 13, 2023
Lead Product(s) : Voclosporin
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Lupkynis (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action. It is being developed for the treatment of lupus nephritis.
Product Name : Lupkynis
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
November 13, 2023
Details:
Lupkynis (voclosporin) is an an oral calcineurin inhibitor which is being evaluated in clinical trials for the treatment of patients with Lupus Nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Brand Name: Lupkynis
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Otsuka Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 10, 2023
Lead Product(s) : Voclosporin
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Otsuka Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Lupkynis (voclosporin) is an an oral calcineurin inhibitor which is being evaluated in clinical trials for the treatment of patients with Lupus Nephritis.
Product Name : Lupkynis
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
November 10, 2023
Details:
Voclosporin is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Lupus Nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Nephrology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Peptide, Unconjugated
Sponsor: Labcorp
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 27, 2023
Lead Product(s) : Voclosporin
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Labcorp
Deal Size : Inapplicable
Deal Type : Inapplicable
Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
Details : Voclosporin is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Lupus Nephritis.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
July 27, 2023
Details:
Lupkynis (voclosporin) is a calcineurin-inhibitor of calcineurin. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens. Currently being developed for lupus nephritis.
Lead Product(s): Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area: Nephrology Brand Name: Lupkynis
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 03, 2023
Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurinia Pharmaceuticals Announces NICE Recommendation of LUPKYNIS® (Voclosporin) For Adults with ...
Details : Lupkynis (voclosporin) is a calcineurin-inhibitor of calcineurin. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens. Currently being develope...
Product Name : Lupkynis
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
May 03, 2023
Details:
Lupkynis (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with dual mechanism of action, has received swissmedic approval to treat adults with active class III, IV and V lupus nephritis.
Lead Product(s): Voclosporin
Therapeutic Area: Immunology Brand Name: Lupkynis
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 02, 2023
Lead Product(s) : Voclosporin
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurinia Pharmaceuticals Announces Swissmedic Approval of LUPKYNIS® (voclosporin)
Details : Lupkynis (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with dual mechanism of action, has received swissmedic approval to treat adults with active class III, IV and V lupus nephritis.
Product Name : Lupkynis
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
May 02, 2023
Details:
Lupkynis (voclosporin) is a calcineurin-inhibitor of calcineurin. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens. Currently being developed for lupus nephritis.
Lead Product(s): Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area: Nephrology Brand Name: Lupkynis
Study Phase: PreclinicalProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 11, 2023
Lead Product(s) : Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area : Nephrology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurinia Pharmaceuticals Announces New and Refined Method of Use Patent for LUPKYNIS® in the Treat...
Details : Lupkynis (voclosporin) is a calcineurin-inhibitor of calcineurin. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens. Currently being develope...
Product Name : Lupkynis
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
April 11, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : LUPKYNIS
Dosage Strength : 7.9MG
Packaging :
Approval Date : 2021-01-22
Application Number : 213716
Regulatory Info : RX
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
Dosage Form : CAPSULE; ORAL
Proprietary Name : LUPKYNIS
Dosage Strength : 7.9MG
Approval Date : 2021-01-22
Application Number : 213716
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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