FDA Accepts Sparsentan sNDA for Full Approval in Focal Segmental Glomerulosclerosis
The FDA has accepted Travere Therapeutics' supplemental New Drug Application for traditional approval of sparsentan (Filspari) in focal segmental glomerulosclerosis, with a decision expected by January 2026.
IgA Nephropathy Pipeline Shows Robust Growth with 30+ Therapies in Development
DelveInsight's 2025 pipeline analysis reveals over 30 companies developing 30+ therapies for IgA nephropathy treatment, representing a robust therapeutic landscape.
Scotiabank Raises Travere Therapeutics' Price Target Following Planned Filspari sNDA Filing
Scotiabank analyst Greg Harrison has increased Travere Therapeutics' price target to $32 from $27, maintaining an Outperform rating on the company's shares.
Experts Explore Hierarchical Composite Endpoints to Transform Nephrology Clinical Trials
• Leading nephrologists and researchers discuss how Hierarchical Composite Endpoints (HCEs) integrate multiple clinical measures including death, dialysis, and eGFR decline to create more comprehensive disease progression assessments. • The win odds approach in HCEs demonstrates advantages over traditional hazard ratios, offering improved interpretability and statistical power in clinical trial analysis. • Implementation of HCEs in nephrology trials could significantly reduce required patient sample sizes while maintaining scientific rigor, potentially accelerating the drug development process.
Travere Therapeutics Plans sNDA Submission for FILSPARI to Treat Rare Kidney Disease FSGS
Travere Therapeutics has completed a Type C meeting with the FDA and plans to submit a supplemental New Drug Application for FILSPARI to treat focal segmental glomerulosclerosis by Q1 2025.
EMA Panel Recommends Sparsentan for IgA Nephropathy, Paving Way for EU Approval
The EMA's human medicines committee (CHMP) has recommended sparsentan for IgA nephropathy (IgAN) treatment in adults with significant proteinuria.
PARASOL Initiative Identifies Proteinuria as Surrogate Endpoint in FSGS Trials
The PARASOL initiative analyzed 1600 FSGS patients to identify reliable surrogate endpoints for clinical trials, addressing the challenge of long follow-up periods.
Renalys Pharma Completes Enrollment in Phase III Trial of Sparsentan for IgA Nephropathy in Japan
Renalys Pharma has completed patient enrollment for its Phase III clinical trial of sparsentan in Japan for IgA nephropathy.
Industry Leaders Unite to Tackle Patient Recruitment Challenges in Rare Disease Clinical Trials
• Over 80% of U.S. clinical trials fail to meet patient enrollment timelines, highlighting the significant challenges in rare disease research and patient recruitment. • Leading pharmaceutical companies including Biogen, Astellas Pharma, and Novo Nordisk are collaborating to address patient recruitment obstacles through innovative strategies and enhanced diversity initiatives. • The Patient Recruitment for Rare Disease Trials Summit brings together experts to explore solutions for patient engagement, data sharing, and fair compensation while maintaining trial integrity.
Travere Therapeutics' Filspari Shows Sustained Benefit in IgAN and FSGS
FILSPARI (sparsentan) demonstrates significant proteinuria reduction and complete remission in IgAN patients, particularly as a first-line treatment.