Peptide News Digest

#Fabhalta

2 stories

Industry · View digest

July 2026 Peptide-and-Obesity Regulatory-and-Industry Month-in-Review: The Most Consequential Policy Month in the Site's Coverage Window With the July 1 Medicare GLP-1 Bridge Program Launch (Wegovy, Zepbound KwikPen, and Foundayo at $50/Month Copay for ~3.8 Million Eligible Part D Beneficiaries Through December 31 2027), the July 23-24 FDA Pharmacy Compounding Advisory Committee (PCAC) Two-Day Session Recommending 6 of 7 Research Peptides for the Section 503A Bulks List (BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon Approved; Emideltide/DSIP Rejected), the July 16 FDA Approval of Merck LIPFENDRA (Enlicitide) as the First Once-Daily Oral Macrocyclic Peptide PCSK9 Inhibitor, and the July 30 Close of the 503B GLP-1 Bulks List Exclusion Comment Period

July 2026 closed as the most consequential peptide-and-obesity policy month in the site's coverage window. Regulatory milestones: the July 1 Medicare GLP-1 Bridge Program launch providing Wegovy (semaglutide), Zepbound KwikPen (tirzepatide), and Foundayo (orforglipron) at $50/month capped copay for approximately 3.8 million eligible Medicare Part D beneficiaries through December 31, 2027; the July 23-24 FDA Pharmacy Compounding Advisory Committee (PCAC) two-day session recommending 6 of 7 research peptides for the Section 503A Bulks List (BPC-157 8-6-1, KPV 8-6-1, TB-500 8-6, MOTS-c 7-5-2, Semax 8-5, Epitalon 7-4; Emideltide/DSIP rejected); the July 30 close of the 503B GLP-1 Bulks List exclusion comment period on the April 30 proposed rule to permanently exclude semaglutide, tirzepatide, and liraglutide; and the Section 232 pharmaceutical tariffs effective date July 31. Product milestones: the July 16 FDA approval of Merck LIPFENDRA (enlicitide) as the first once-daily oral macrocyclic peptide PCSK9 inhibitor (56-59% LDL reduction in CORALreef Phase 3, $315/month launch pricing); the July 7 FDA accelerated approval of Vera Therapeutics TRUTAKNA (atacicept-vymj) for primary IgA nephropathy; the July 17 FDA traditional approval of Novartis Fabhalta (iptacopan) for IgAN; the July 23 Arrowhead Redemplo (plozasiran) Phase 3 SHASTA-3 and SHASTA-4 positive readout (79-81% triglyceride reduction). Industry milestones: the July 19-20 Samsung Biologics $1.8 billion all-cash tender offer for PolyPeptide; the July 21 Novo Nordisk lawsuit and July 24 TRO filing against Eli Lilly over GLP-1 advertising; the July 20-23 EMA CHMP recommendation for lerodalcibep (Lyrokaul) monthly PCSK9 fusion protein.

Regulatory · View digest

FDA Grants Novartis Fabhalta (Iptacopan) Traditional Approval Today Friday July 17 as the First and Only Complement Factor B Inhibitor Approved to Slow Kidney Function Decline in Adults With Primary IgA Nephropathy at Risk of Disease Progression: Phase 3 APPLAUSE-IgAN Data Showed a 3.02 mL/min/1.73 m² Per Year Difference in eGFR Slope for a 48% Slower Decline in Patients Receiving Iptacopan Versus Placebo, Following the August 2024 Accelerated Approval for Proteinuria Reduction; The Approval Extends the IgAN Competitive Set That Vera Therapeutics Entered on July 7 With Trutakna (Atacicept-Vymj) BAFF/APRIL Peptide-and-Fc Fusion Protein Accelerated Approval

Novartis (SIX: NOVN) announced Friday July 17, 2026 that the FDA has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. Fabhalta is a first-in-class complement Factor B inhibitor (small molecule); the traditional approval converts the August 2024 FDA accelerated approval (which was based on proteinuria reduction) into a full label supported by kidney-function outcomes. The Phase 3 APPLAUSE-IgAN trial showed a 3.02 mL/min/1.73 m² per year difference in estimated glomerular filtration rate (eGFR) slope in the iptacopan arm versus placebo, translating to a 48% slower kidney-function decline. The approval extends the primary IgA nephropathy competitive set that Vera Therapeutics entered on July 7, 2026 when Trutakna (atacicept-vymj), a BAFF/APRIL-targeting peptide-and-Fc fusion protein, received FDA accelerated approval based on a 45.7% versus 6.8% reduction in urine protein-to-creatinine ratio in the Phase 3 ORIGIN trial. IgA nephropathy affects approximately 130,000-150,000 Americans and is the most common primary glomerular disease worldwide; roughly 40% of patients progress to end-stage renal disease within 20 years without effective treatment.