Peptide News Digest

#Lerodalcibep

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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

European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) Closes July 20-23, 2026 Meeting With a Recommendation for EU Marketing Authorisation of Lyrokaul (Lerodalcibep), a Once-Monthly Self-Administered Subcutaneous Third-Generation PCSK9 Inhibitor Fusion Protein, for Adult Primary Hypercholesterolaemia and Mixed Dyslipidaemia With 59-65% Placebo-Adjusted LDL-C Reductions From the Phase 3 LIBerate-HeFH Registrational Trial in Adults With Heterozygous Familial Hypercholesterolaemia on Maximally Tolerated Statin Therapy; European Commission Marketing Authorisation Decision Typically Follows 2-3 Months

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) closed its July 20-23, 2026 meeting with a recommendation for EU marketing authorisation of Lyrokaul (lerodalcibep). Lerodalcibep is a third-generation PCSK9 inhibitor administered as a once-monthly self-administered subcutaneous injection. The active substance is an adnectin-Fc fusion protein that binds proprotein convertase subtilisin/kexin type 9 (PCSK9), preventing PCSK9-mediated degradation of LDL receptors in the liver and enhancing LDL-C clearance from circulation. In the Phase 3 LIBerate-HeFH registrational trial, adults with heterozygous familial hypercholesterolaemia (HeFH) on maximally tolerated statin therapy achieved placebo-adjusted LDL-C reductions of roughly 59-65% by Week 24, with approximately two-thirds of participants reaching European Society of Cardiology-recommended targets. The CHMP recommendation covers use in addition to diet, alone or in combination with other lipid-lowering therapies. European Commission marketing authorisation decisions typically follow CHMP recommendations by 2-3 months. Lerodalcibep received US FDA approval earlier in 2026 under the brand name Lerochol. The EU authorization would add a third-generation PCSK9 modality alongside injectable antibodies (Repatha/evolocumab, Praluent/alirocumab), the siRNA (Leqvio/inclisiran), and the oral macrocyclic peptide (LIPFENDRA/enlicitide, US-only as of July 25, 2026).