Peptide News Digest

#Atacicept

2 stories

Industry · View digest

Vera Therapeutics Announces TRUTAKNA (Atacicept-Vymj) Commercial Launch Details Following July 7 FDA Accelerated Approval: $425,000 Per Year List Price for the BAFF/APRIL-Targeting Peptide-and-Fc Fusion Protein, 82 Sales Representatives Deployed at Launch, In-Channel Pharmacy Availability Within Three to Four Weeks, and Ongoing ORIGIN 3 Confirmatory Trial (Blinded Placebo-Controlled eGFR Endpoint) With Results Anticipated in Q3 2026 That Will Determine Whether the Accelerated Approval Converts to Traditional Approval

Vera Therapeutics (NASDAQ: VERA) confirmed commercial-launch parameters for TRUTAKNA (atacicept-vymj) following the July 7, 2026 FDA accelerated approval for adults with primary IgA nephropathy at risk of rapid disease progression. List price: $425,000 per year for the recombinant peptide-and-Fc fusion protein (TACI extracellular domain fused to human IgG1 Fc). Sales force: 82 representatives deployed at launch. Distribution: in-channel pharmacy availability within three to four weeks of approval, with insurance coverage under specialty-pharmacy medical benefit pathways given the subcutaneous injection administration. The July 7 accelerated approval was based on the Phase 3 ORIGIN study 36-week urine protein-to-creatinine ratio (UPCR) endpoint (45.7% reduction versus 6.8% for standard of care). Continued FDA approval may be contingent on verification of clinical benefit in the ongoing ORIGIN 3 confirmatory trial, which continues in a placebo-controlled blinded manner to evaluate change in kidney function as measured by estimated glomerular filtration rate (eGFR); results are anticipated in Q3 2026. If the ORIGIN 3 eGFR data hit, TRUTAKNA converts to traditional approval on the harder outcome endpoint.

Regulatory · View digest

FDA Grants Accelerated Approval for Vera Therapeutics' Trutakna (Atacicept-Vymj) for Adult Patients with Primary IgA Nephropathy on Tuesday July 7: BAFF/APRIL-Targeting Fusion Protein Cut Proteinuria 45.7% Versus 6.8% for Standard of Care Alone at 36 Weeks in the ORIGIN Phase 3 Trial

The FDA granted accelerated approval Tuesday July 7, 2026 to Trutakna (atacicept-vymj) for adult patients with primary IgA nephropathy (IgAN) at risk of rapid disease progression, in combination with standard of care. Vera Therapeutics developed the drug as a recombinant fusion protein that combines the extracellular domain of the transmembrane activator and CAML interactor (TACI) receptor with the Fc portion of human IgG1, binding both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) to reduce autoantibody-driven kidney damage. The registrational Phase 3 ORIGIN trial data supporting approval: at 36 weeks, Trutakna plus standard of care produced a 45.7% reduction in urine protein-to-creatinine ratio versus a 6.8% reduction for standard of care alone. IgA nephropathy affects approximately 130,000 to 150,000 Americans and is the most common primary glomerular disease worldwide; approximately 40% of patients progress to end-stage renal disease within 20 years without adequate treatment. Trutakna is a fusion protein rather than a peptide but sits in adjacent therapeutic territory relevant to the site's peptide-and-biologic coverage. Vera Therapeutics (NASDAQ: VERA) is expected to launch the product in Q3 2026. Continued approval may be contingent on verification of clinical benefit in confirmatory Phase 3 studies.