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Autoimmune disease stories

Sep 23, 2026

Roche kidney disease drug succeeds in Phase 3 trial for IgA nephropathy

Roche's experimental RNA drug sefaxersen significantly reduced proteinuria in a late-stage trial for IgA nephropathy, positioning the company to bring a new treatment to market for the autoimmune kidney disease that currently has limited approved therapies.

Sep 23, 2026·3 sources
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Sep 22, 2026

Amgen's dazodalibep succeeds in Phase 3 trial for Sjögren's disease

Amgen reported positive Phase 3 results for dazodalibep in moderate-to-severe Sjögren's disease, a chronic autoimmune condition with no currently approved therapies. The drug was acquired through Amgen's $28 billion Horizon Therapeutics buyout.

Sep 22, 2026·4 sources
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Sep 2, 2026

Teva's celiac disease drug prevents intestinal damage in gluten challenge trial

Teva's experimental drug prevented intestinal damage in celiac disease patients who underwent a gluten challenge in a mid-stage study, representing potential progress for a condition with no current drug treatments.

Sep 2, 2026·2 sources
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Sep 1, 2026

Alumis experimental lupus drug fails primary endpoint in phase 3 trial

Alumis reported its experimental TYK2 inhibitor failed to meet the main goal of a late-stage lupus trial, though the company plans to advance the drug in a smaller subset of patients.

Sep 1, 2026·2 sources
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Novartis pauses autoimmune cell therapy trials after three patient deaths

Novartis temporarily halted enrollment and treatment in eight clinical trials of an experimental CAR-T therapy for autoimmune and neurological disorders in late August after three patients died. Bristol Myers Squibb programs were also paused.

Sep 1, 2026·3 sources
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Aug 28, 2026

Priovant receives first FDA approval for targeted tablet in dermatomyositis

Priovant Therapeutics secured its first FDA approval for a targeted tablet treatment for dermatomyositis, a rare autoimmune disease affecting muscles and skin.

Aug 28, 2026·2 sources
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Jun 26, 2026

European Medicines Agency Recommends Revoking Amgen's Tavneos Over Data Integrity Issues

The European Medicines Agency recommended withdrawing marketing authorization for Amgen's rare autoimmune disease drug Tavneos, citing allegedly incorrect and misleading data used in the approval process and lack of benefits outweighing risks.

Jun 26, 2026·3 sources
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Apr 11, 2026

CAR-T Therapy Shows Continued Success in Autoimmune Diseases Five Years After Lupus Breakthrough

Five years after initial lupus breakthrough, CAR-T cell therapy continues to demonstrate remissions in autoimmune diseases, generating significant research investment and experimentation beyond its original cancer applications.

Apr 11, 2026·1 source
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Apr 6, 2026

Scripps Research Develops New Anti-Inflammatory Drug Class That Preserves Immune Function

Scripps Research scientists have developed a first-in-class drug compound that reduces harmful inflammation while leaving the body's ability to fight infections intact, addressing a long-sought goal in treating autoimmune diseases.

Apr 6, 2026·1 source
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FDA Delay Forces Small Biotech Company to Shut Down Operations

A small biotech company was forced to wind down operations after the FDA abruptly postponed a key meeting for four months, despite reaching a clinical trial agreement in February that came too late.

Apr 6, 2026·2 sources
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Top claims

  • ▪The Food and Drug Administration has granted accelerated clearances for IgA nephropathy drugs from Otsuka Pharmaceutical and Vera Therapeutics, with Calliditas, Travere, and potentially Vertex Pharmaceuticals also in the IgA nephropathy market
  • ▪If sefaxersen is approved, it would compete in a crowded market against Novartis' Fabhalta, which is priced at approximately $400,000 to $500,000 a year
  • ▪Roche Holding's base business is experiencing slow growth as the Swiss pharmaceutical giant absorbs patent expirations for key products

Topics

Drug Approval and Clinical TrialsPharmaPharmaceutical IndustryClinical trialsDrug developmentLifestyle, Wellness and NutritionCAR T-cell therapyNeurological disordersFDA drug approvalEuropean UnionAging biology expertsBiomarkers & bloodwork testingInflammation reduction & immune effectsLongevity biotech founders

Related entities

LupusTargeted therapiesRare DiseaseGermanyInflammationImmunologyRheumatoid arthritis