IgA nephropathy

New Drug Application Approval by the Pharmaceutical Administration Bureau of Macau for Nefecon® for the Treatment of Primary IgA Nephropathy

Retrieved on: 
Friday, October 27, 2023

The approval for Nefecon is for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.

Key Points: 
  • The approval for Nefecon is for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.
  • Macau is the first region in Everest territories that received Nefecon approval.
  • The NDA for Nefecon in mainland China is under Priority Review and Nefecon was the first non-oncology medicine to receive Breakthrough Therapy Designation in China.
  • Nefecon has been available for clinical use in Shanghai Ruijin Hospital's Hainan subsidiary through an early-access program since April 2023.

BioCryst Begins Enrollment in Proof-of-Concept Trial to Confirm Safe, Effective, Once-daily Dose of Oral Factor D Inhibitor, BCX10013

Retrieved on: 
Thursday, October 26, 2023

RESEARCH TRIANGLE PARK, N.C., Oct. 26, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the enrollment of the first patient in a proof-of-concept clinical trial evaluating BCX10013, a potential once-daily, oral Factor D inhibitor for the treatment of complement-mediated diseases.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Oct. 26, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the enrollment of the first patient in a proof-of-concept clinical trial evaluating BCX10013, a potential once-daily, oral Factor D inhibitor for the treatment of complement-mediated diseases.
  • The goal of this proof-of-concept trial is to understand the preliminary efficacy and safety profile of once-daily dosing with BCX10013.
  • The trial design employs intra-subject dose escalation approximately every four weeks with the option to continue treatment for up to 24 weeks.
  • For more information about the trial, visit ClinicalTrials.gov and search NCT number NCT06100900.

Calliditas Therapeutics to Present Seven Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Thursday, October 19, 2023

STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.

Key Points: 
  • STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.
  • Poster presentation details are below and will be available on the Presentation and Publication page on the Calliditas' corporate website following the meeting.
  • It has not been established whether TARPEYO slows kidney function decline in patients with IgAN.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.

Calliditas Therapeutics to Present Seven Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Thursday, October 19, 2023

STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.

Key Points: 
  • STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.
  • Poster presentation details are below and will be available on the Presentation and Publication page on the Calliditas' corporate website following the meeting.
  • It has not been established whether TARPEYO slows kidney function decline in patients with IgAN.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.

Travere Therapeutics to Present Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Friday, October 13, 2023

SAN DIEGO, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced that the Company will present 11 abstracts, including two late-breaking oral presentations, at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 2-5, 2023.

Key Points: 
  • SAN DIEGO, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced that the Company will present 11 abstracts, including two late-breaking oral presentations, at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 2-5, 2023.
  • Presentations will highlight the long-term efficacy and tolerability data of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) from the PROTECT Study, as well as the potential for use of FILSPARI as a first-line treatment in newly diagnosed IgAN patients and in combination with SGLT2 inhibitors.
  • The Company will also present data on the efficacy and tolerability of sparsentan in focal segmental glomerulosclerosis (FSGS) and pediatric proteinuric glomerular diseases, as well as provide insights into patient quality of life and the impact of proteinuria on kidney survival in rare kidney diseases.
  • “The data we and our collaborators are presenting at ASN are a testament to our collective dedication to enhance our scientific understanding of kidney diseases to improve patients’ lives,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.

US Nephrologists Embrace Current IgA Nephropathy Therapies, Yet a Thriving Pipeline Signals Fierce Market Evolution Ahead

Retrieved on: 
Friday, October 13, 2023

Despite the welcomed additions to the armamentarium, data from Spherix’s 2023 Market Dynamix: IgA Nephropathy (US) service reveals that nephrologists still consider there to be a high unmet need for new therapies.

Key Points: 
  • Despite the welcomed additions to the armamentarium, data from Spherix’s 2023 Market Dynamix: IgA Nephropathy (US) service reveals that nephrologists still consider there to be a high unmet need for new therapies.
  • As a result, access has understandably become a more prominent and pressing concern, overshadowing the actual availability of disease-targeted treatment options.
  • The landscape of the IgAN pipeline is in a constant state of evolution, with one of the most recent developments coming from Novartis.
  • Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.

Vera Therapeutics to Present Three Posters at the American Society of Nephrology Kidney Week 2023 Annual Meeting

Retrieved on: 
Friday, October 13, 2023

BRISBANE, Calif., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that three abstracts on the Company’s product candidate atacicept in immunoglobulin A nephropathy (IgAN) have been selected for poster presentations at the American Society of Nephrology (ASN) Kidney Week 2023, which is taking place November 2–5, 2023, in Philadelphia, PA.

Key Points: 
  • Additional analysis of week 36 data from Phase 2b ORIGIN study show atacicept 150mg reduces serum Gd-IgA1, supporting atacicept’s potential as long-term disease-modifying IgAN therapy
    Atacicept showed continued protective titers to diphtheria and tetanus and balanced COVID infections vs. placebo in IgAN
    BRISBANE, Calif., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that three abstracts on the Company’s product candidate atacicept in immunoglobulin A nephropathy (IgAN) have been selected for poster presentations at the American Society of Nephrology (ASN) Kidney Week 2023, which is taking place November 2–5, 2023, in Philadelphia, PA.
    Kidney Week Poster Presentation Details:
    Jonathan Barratt, Ph.D., FRCP, The Mayer Professor of Renal Medicine, University of Leicester, UK

Omeros Corporation Provides Update on Interim Analysis of ARTEMIS-IGAN Phase 3 Trial of Narsoplimab in IgA Nephropathy

Retrieved on: 
Monday, October 16, 2023

Topline results show that narsoplimab did not achieve statistically significant improvement over placebo.

Key Points: 
  • Topline results show that narsoplimab did not achieve statistically significant improvement over placebo.
  • The UPE reduction in the placebo group was markedly greater than that reported in trials of other agents in IgA nephropathy.
  • Based on the absence of statistical significance and as previously agreed with FDA, Omeros will not submit an application for approval of narsoplimab in this indication and will discontinue the ARTEMIS-IGAN clinical trial.
  • “We want to thank all the patients and investigators who participated in the trial,” said Gregory A. Demopulos, M.D, chairman and chief executive officer of Omeros.

Alpine Immune Sciences to Present Initial Clinical Data on Povetacicept in Autoimmune Glomerulonephritis in a Late Breaker Poster Session at American Society of Nephrology Kidney Week 2023

Retrieved on: 
Friday, October 13, 2023

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the Company will present initial clinical data from RUBY-3, a phase 1b/2a study of povetacicept in autoimmune glomerulonephritis including IgA nephropathy, in a late breaking poster presentation at the American Society of Nephrology (ASN) Kidney Week, November 1-5, 2023 in Philadelphia, Pennsylvania.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the Company will present initial clinical data from RUBY-3, a phase 1b/2a study of povetacicept in autoimmune glomerulonephritis including IgA nephropathy, in a late breaking poster presentation at the American Society of Nephrology (ASN) Kidney Week, November 1-5, 2023 in Philadelphia, Pennsylvania.
  • Following the poster presentation, the Company will host an investor event after the close of the market.
  • Poster Title: Povetacicept, an Enhanced Dual BAFF/APRIL Antagonist, in Autoantibody-Associated Glomerulonephritis (GN)
    Presenter: James Tumlin, M.D., Professor of Medicine at Emory University School of Medicine, Founder and CEO of NephroNet Clinical Trials Consortium

Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy

Retrieved on: 
Tuesday, October 3, 2023

STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.

Key Points: 
  • STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.
  • Kinpeygo is an orphan medicinal product and the first and only treatment approved in the UK for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need.
  • Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
  • : +46 76 403 35 43, email: [email protected]
    The information was sent for publication, through the agency of the contact persons set out above, on October 3, 2023 at 09:20 a.m. CET.