Immunoglobulin A

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.

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.

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.

Ionis enters agreement with Roche for two novel RNA-targeted programs for Alzheimer's disease and Huntington's disease

Retrieved on: 
Wednesday, September 27, 2023

"We are excited to expand our partnership with Roche, a global leader in developing and delivering innovative treatments to patients," said Brett P. Monia, Ph.D., Ionis' chief executive officer.

Key Points: 
  • "We are excited to expand our partnership with Roche, a global leader in developing and delivering innovative treatments to patients," said Brett P. Monia, Ph.D., Ionis' chief executive officer.
  • "With this new collaboration, we are joining forces to accelerate the discovery and development of novel therapies for people living with Alzheimer's disease and Huntington's disease globally.
  • Collaborating on these two programs enables Ionis to advance our wholly owned programs, including those in neurology, aligned with our strategic priorities."
  • IONIS-FB-LRx is currently in a Phase 2 study for GA, led by Ionis, and a Phase 3 study for IgAN led by Roche.

Travere Therapeutics to Present Abstracts at the 17th International Symposium on IgA Nephropathy (IIGANN 2023)

Retrieved on: 
Tuesday, September 26, 2023

SAN DIEGO, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company and its collaborators will present preliminary findings from the SPARTAN Study evaluating the potential effect of FILSPARI® (sparsentan) as a first-line therapy in patients with newly diagnosed IgA nephropathy (IgAN) in a late-breaking trial session at the 17th International Symposium on IgA Nephropathy (IIGANN2023) in Ryogoku, Tokyo, September 28-30, 2023.

Key Points: 
  • SAN DIEGO, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company and its collaborators will present preliminary findings from the SPARTAN Study evaluating the potential effect of FILSPARI® (sparsentan) as a first-line therapy in patients with newly diagnosed IgA nephropathy (IgAN) in a late-breaking trial session at the 17th International Symposium on IgA Nephropathy (IIGANN2023) in Ryogoku, Tokyo, September 28-30, 2023.
  • The Company will also present preclinical data supporting the nephroprotective mechanism of action of sparsentan, a dual endothelin angiotensin receptor antagonist, and an analysis of the UK National Registry of Rare Renal Diseases (RaDaR) which demonstrated that patients with IgAN traditionally considered ‘low-risk’, with proteinuria less than one gram per day, had high rates of kidney failure.
  • “Patients with IgA nephropathy need both early and effective treatment options capable of significant and sustained reduction of proteinuria to preserve kidney function,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.
  • “We’re pleased to be presenting 24-week data on proteinuria reduction, blood pressure control, and safety from the ongoing SPARTAN Study evaluating the effect of sparsentan as a first-line treatment option in patients with newly diagnosed IgAN.”
    Sparsentan Treatment of Incident Patients With IgA Nephropathy as First-line Therapy: Interim Findings From the SPARTAN Trial

American Kidney Fund Launches Educational Awareness Campaigns for Two Rare Kidney Diseases

Retrieved on: 
Tuesday, September 26, 2023

ROCKVILLE, Md., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Today, the American Kidney Fund (AKF) launched educational awareness campaigns for two rare kidney diseases: complement 3 glomerulopathy (C3G) and IgA nephropathy (IgAN).

Key Points: 
  • ROCKVILLE, Md., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Today, the American Kidney Fund (AKF) launched educational awareness campaigns for two rare kidney diseases: complement 3 glomerulopathy (C3G) and IgA nephropathy (IgAN).
  • The campaigns, sponsored by Novartis, provide patients with information about the diseases and connect them with resources to help them better understand and manage these conditions.
  • C3G and IgAN are two types of kidney diseases that are related to improper function of the immune system, which is your body's cells and tissues that fight infection.
  • The C3G and IgAN campaigns are part of AKF’s ongoing work to increase awareness and understanding of rare kidney diseases and ensure people with these conditions have access to critical resources.