Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 1 day ago
- 2 min read
07/07/2026
Vera Therapeutics announced US FDA accelerated approval of TRUTAKNAâ„¢ for adults with primary IgA nephropathy (Ref)
Vera Therapeutics announced that the US FDA had granted TRUTAKNA (atacicept-vymj; a BAFF and APRIL inhibitor) accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression.
This accelerated approval was based on the reduction in proteinuria seen in the Phase 3, ORIGIN 3/NCT04716231 study.
In a prespecified interim analysis of the ongoing ORIGIN 3 trial, participants treated with TRUTAKNA achieved a 46% reduction from baseline in proteinuria, with a statistically significant and clinically meaningful 42% reduction compared to placebo (p<0.0001) at 36 weeks.
In this Phase 3 study TRUTAKNA was generally well tolerated.
Turn Therapeutics announced the final stage 2 design and data-driven expansion of the GX-03 phase 2 trial in Atopic Dermatitis (Ref)
Turn Therapeutics announced the completion of a comprehensive interim analysis of its ongoing adaptive Phase 2 trial evaluating GX-03 for the treatment of atopic dermatitis(AD).
In the interim analysis, GX-03 demonstrated clinically meaningful efficacy in patients with baseline EASI scores of 1.1 to 7.0, showing activity across a wider spectrum of AD severity than originally anticipated, and supporting expansion of the study population to prospectively evaluate patients across the full range of disease severity.
The final Stage 2 design incorporated data-driven refinements to patient selection, disease stratification, endpoint evaluation, and statistical methodology.
The trial would use the FDA-recognized Hochberg multiple testing procedure, allowing statistical significance to be established across multiple efficacy endpoints rather than a single primary endpoint.
Enrollment completion was anticipated in the fourth quarter of 2026.
Everest Medicines announced the closing of its exclusive licencing agreement with Travere Therapeutics for civorebrutinib (Ref)
Everest Medicines announced the closing of its exclusive licensing and collaboration agreement with Travere Therapeutics for the development and commercialization of civorebrutinib (EVER001; BTK inhibitor) in the US and global markets excluding Greater China and certain countries in East and Southeast Asia.
Under the terms of the agreement, Everest received an upfront payment of $112.5 million from Travere Therapeutics after the closing of the transaction.
Everest was also eligible to receive up to approximately $1.03 billion in clinical development, regulatory and commercial milestones payments across up to five indications.
Travere will also pay tiered royalties on future sales in its licensed territories.