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Vera has reported the P-III (ORIGIN 3) trial data assessing Trutakna vs PBO in adults with primary IgAN at risk for disease progression, which met all of its prespecified endpoints. The company is planning to submit an sBLA to the FDA for full approval in Q4’26
In 428 pts, Trutakna preserved kidney function at…
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The US FDA approved six notable therapies in July 2026 across nephrology, oncology, cardiometabolic disease, ophthalmology, and neuropsychiatry, highlighting continued progress in specialty and chronic disease treatment.
Key approvals included Trutakna (atacicept) for IgA nephropathy, Revtorpyk (gedatolisib) for HR+/HER2- breast cancer, Lipfendra (enlicitide) for hypercholesterolemia, Jideytro (zidesamtinib) for ROS1-positive NSCLC, Lytenava (bevacizumab-vikg) for wet AMD, and Simtriyo (centanafadine) for ADHD, expanding treatment options across diverse patient…
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The US FDA has granted accelerated approval to Trutakna to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression
Approval was supported by the ongoing global P-III (ORIGIN 3) trial evaluating atacicept (150mg, SC, QW) vs PBO in adults with IgAN, assessing eGFR-based kidney function over 2yrs., with…

