Keros to Start Rinvatercept DMD Trial in Q1 2026, Plans ALS Regulatory Talks
Keros Therapeutics plans a phase II DMD trial of rinvatercept in Q1 2026 and regulatory talks for ALS in H2 2026. Cash stands at $383 million with runway into H1 2028.
Glucocorticoids
DrugRelated News
Gene Therapy for Knee Osteoarthritis Advances; India Plans Regulatory Framework
Five intra-articular gene therapy platforms for knee osteoarthritis are in human trials in the US, while India prepares regulatory guidelines for mRNA, gene and cell therapies to accelerate innovation.
Sanofi's Rilzabrutinib Gains Regulatory Designations in Japan and U.S. for Rare Diseases
Sanofi's oral BTK inhibitor rilzabrutinib received orphan drug designation in Japan for IgG4-related disease and warm autoimmune hemolytic anemia, while also securing U.S. FDA breakthrough therapy designation for the rare anemia indication.
Sanofi's Rilzabrutinib Receives Orphan Drug Designation in Japan for IgG4-Related Disease
Japan's Ministry of Health, Labour and Welfare has granted orphan drug designation to Sanofi's rilzabrutinib for IgG4-related disease, marking the third global orphan designation for this indication based on positive phase 2 study data.
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