Aurinia

Aurinia Pharmaceuticals Announces Collaboration Partner Otsuka Filed New Drug Application (NDA) for LUPKYNIS® (Voclosporin) in Japan

Retrieved on: 
Monday, November 13, 2023

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the Company’s collaboration partner, Otsuka Pharmaceutical Ltd., filed a new drug application (NDA) for voclosporin for the treatment of lupus nephritis (LN) with the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale in Japan of voclosporin, a second-generation oral calcineurin inhibitor for the treatment of lupus nephritis (LN).

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the Company’s collaboration partner, Otsuka Pharmaceutical Ltd., filed a new drug application (NDA) for voclosporin for the treatment of lupus nephritis (LN) with the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale in Japan of voclosporin, a second-generation oral calcineurin inhibitor for the treatment of lupus nephritis (LN).
  • LN is a complication of the autoimmune disease systemic lupus erythematosus (SLE) that seriously impacts the kidneys.
  • Aurinia and Otsuka entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine.
  • As part of the agreement, Aurinia is eligible to receive a payment of $10 million upon approval in Japan along with low double-digit royalties on net sales once launched.

Spherix Global Insights Amplifies the Lupus Patient Voice, Highlighting the Lengthy and Challenging Journey to Diagnosis and Treatment

Retrieved on: 
Wednesday, November 8, 2023

Upon consulting healthcare professionals, a substantial portion faced prolonged diagnostic journeys, enduring over a year to receive an accurate diagnosis.

Key Points: 
  • Upon consulting healthcare professionals, a substantial portion faced prolonged diagnostic journeys, enduring over a year to receive an accurate diagnosis.
  • Indeed, SLE patients commonly experience a myriad of concurrent health conditions, with approximately one-fifth officially diagnosed with lupus nephritis.
  • Notwithstanding this yearning for more information, the Lupus patient community remains remarkably self-empowered, often relying on personal research for insights into their condition.
  • Patient Voice Dynamix™ is an independent service that explores the voice of the patient as they progress through their disease and treatment journeys.

Aurinia Presents Breadth of Data from AURORA Clinical Program Underscoring Value of LUPKYNISⓇ (voclosporin) for Patients with Lupus Nephritis at ACR 2023

Retrieved on: 
Tuesday, November 7, 2023

Safety and efficacy outcomes for propensity-matched patients with active LN from the Aspreva Lupus Management Study (ALMS) and the AURORA 1 study were assessed at three and six months.

Key Points: 
  • Safety and efficacy outcomes for propensity-matched patients with active LN from the Aspreva Lupus Management Study (ALMS) and the AURORA 1 study were assessed at three and six months.
  • In AURORA 1, patients received LUPKYNIS® 23.7 mg BID in combination with MMF (target dose 2 g/day) and oral glucocorticoids (starting dose of 25 mg/day tapered to 2.5 mg/day by Week 16).
  • The data showed an improved safety profile over the first six months of treatment with LUPKYNIS® in combination with low-dose glucocorticoids and lower-dose MMF without compromising efficacy.
  • Additional data assessed the disposition of cyclosporine (CSA), tacrolimus (TAC), and voclosporin (VCS) in mouse kidneys relative to its systemic drug exposure.

Aurinia Presents Breadth of Data at ASN 2023 Demonstrating Clinical Importance of LUPKYNISⓇ for Managing Lupus Nephritis

Retrieved on: 
Thursday, November 2, 2023

Results from an analysis of kidney biopsy samples collected from patients participating in the AURORA Clinical Program were presented in an oral session.

Key Points: 
  • Results from an analysis of kidney biopsy samples collected from patients participating in the AURORA Clinical Program were presented in an oral session.
  • Activity scores for both arms improved to a similar degree, while the chronicity scores remained stable in both arms.
  • “The results presented at ASN this week demonstrate important clinical and mechanistic findings associated with LUPKYNISⓇ treatment.
  • Following is the complete guide to Aurinia’s presentations at ASN 2023:
    Title: Comparison of dual-immunosuppressive therapy and a voclosporin-based, triple-immunosuppressive regimen for lupus nephritis: a propensity analysis of ALMS and AURORA 1 studies

Aurinia Pharmaceuticals Reports Third Quarter and Nine Months 2023 Financial and Operational Results

Retrieved on: 
Thursday, November 2, 2023

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today issued its financial results for the three and nine months ended September 30, 2023.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today issued its financial results for the three and nine months ended September 30, 2023.
  • Total net revenue was $54.5 million for the three months ended September 30, 2023 and $55.8 million for the same period in 2022.
  • Financial Results for the Three and Nine Months Ended September 30, 2023
    Total net revenue was $54.5 million and $55.8 million for the three months ended September 30, 2023 and September 30, 2022, respectively.
  • Aurinia will host a conference call and webcast to discuss the quarter ended September 30, 2023 financial results today, Thursday, November 2, 2023 at 8:30 a.m.

Aurinia Response in Support of 2023 Updated EULAR Recommendations for Management of Lupus and New Treatment Paradigm for Lupus Nephritis

Retrieved on: 
Thursday, October 26, 2023

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia welcomes the 2023 updated recommendations from The European Alliance of Associations for Rheumatology (EULAR) for the management of systemic lupus erythematosus (SLE) based on emerging new evidence, including a new treatment paradigm for lupus nephritis (LN).

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia welcomes the 2023 updated recommendations from The European Alliance of Associations for Rheumatology (EULAR) for the management of systemic lupus erythematosus (SLE) based on emerging new evidence, including a new treatment paradigm for lupus nephritis (LN).
  • The new recommendations suggest that in addition to traditional anchor drugs, therapies including LUPKYNIS® (voclosporin) should be considered for any active class of lupus nephritis.
  • “Aurinia appreciates EULAR’s thoughtful consideration for improving the management of lupus nephritis with recommendations that reflect therapeutic advancements in this underserved patient population.
  • The updated recommendations reflect the growing recognition of the clinical value that a therapy like voclosporin provides to people living with lupus nephritis.

Aurinia Pharmaceuticals to Release Third Quarter Financial and Operational Results on November 2, 2023

Retrieved on: 
Thursday, October 19, 2023

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that it will release financial and operational results for the third quarter of 2023, on Thursday, November 2, 2023, before markets open.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that it will release financial and operational results for the third quarter of 2023, on Thursday, November 2, 2023, before markets open.
  • Aurinia’s management team will host a conference call/webcast at 8:30 am ET that day to review these results and provide a general business update.
  • The audio webcast can also be accessed under "News/Events” through the “Investors” section of the Aurinia corporate website at www.auriniapharma.com.
  • A replay of the webcast will be available on Aurinia’s website.

The Lupus Research Alliance Walk with Us to Cure Lupus Takes Off at the Intrepid Museum

Retrieved on: 
Friday, October 20, 2023

NEW YORK, Oct. 20, 2023 /PRNewswire/ -- Thousands of supporters will join together Saturday, October 21 at the Intrepid Museum (formerly called the Intrepid Sea, Air and Space Museum) to celebrate the 20th Anniversary of the Lupus Research Alliance (LRA) 2023 New York City Walk with Us to Cure Lupus.

Key Points: 
  • NEW YORK, Oct. 20, 2023 /PRNewswire/ -- Thousands of supporters will join together Saturday, October 21 at the Intrepid Museum (formerly called the Intrepid Sea, Air and Space Museum) to celebrate the 20th Anniversary of the Lupus Research Alliance (LRA) 2023 New York City Walk with Us to Cure Lupus.
  • That number is still climbing as Walkers continue to fundraise for lupus research.
  • Because the LRA's Board of Directors covers all administrative and fundraising costs, 100 percent of these donations go directly to lupus research programs.
  • Joining the Walk with Us to Cure Lupus program to raise funds is just one way to contribute to the lupus cause.

Aurinia Pharmaceuticals Announces Presentations at American Society of Nephrology (ASN) Kidney Week 2023 and 2023 American College of Rheumatology Convergence (ACR)

Retrieved on: 
Friday, October 13, 2023

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (“Aurinia” or the “Company”), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, today announced that data from 14 studies of LUPKYNIS® (voclosporin) will be presented at the American Society of Nephrology (ASN) Kidney Week 2023, taking place November 2-5 in Philadelphia, Pennsylvania and at the 2023 American College of Rheumatology Convergence (ACR), taking place November 10-15 in San Diego, California.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (“Aurinia” or the “Company”), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, today announced that data from 14 studies of LUPKYNIS® (voclosporin) will be presented at the American Society of Nephrology (ASN) Kidney Week 2023, taking place November 2-5 in Philadelphia, Pennsylvania and at the 2023 American College of Rheumatology Convergence (ACR), taking place November 10-15 in San Diego, California.
  • Led by several leading experts in nephrology and rheumatology, these presentations reinforce the long-term safety and efficacy profile of LUPKYNIS® for the treatment of adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE).
  • The robust set of data demonstrates Aurinia’s deep commitment to sustained research in autoimmune diseases, including lupus.
  • The abstracts for ASN Kidney Week 2023 are listed below and available online at: https://www.asn-online.org/education/kidneyweek/2023/program-search-abst...
    The abstracts for ACR 2023 are listed below and available online at: https://acrabstracts.org/
    Aurinia will issue full data press releases at the time of the meetings.

Aurinia Board of Directors Appoints Dr. Robert T. Foster as New Board Director And Enters Cooperation Agreement with Shareholder MKT Capital

Retrieved on: 
Thursday, September 21, 2023

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (“Aurinia” or the “Company”) today announced that its Board of Directors (“the Board”) has appointed Dr. Robert T. Foster to the Board.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (“Aurinia” or the “Company”) today announced that its Board of Directors (“the Board”) has appointed Dr. Robert T. Foster to the Board.
  • MKT Capital Ltd. (together with its affiliates, “MKT Capital”) submitted Dr. Foster as a candidate and worked collaboratively with Aurinia to name him to the Board.
  • In connection with Dr. Foster’s appointment, MKT Capital has entered into a cooperation agreement with Aurinia.
  • A complete copy of the cooperation agreement will be available on our profiles on EDGAR and SEDAR.