Peptide News Digest

#Redemplo

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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.

Clinical Trials · View digest

Arrowhead Pharmaceuticals (NASDAQ: ARWR) Shares Rise 19% on Thursday July 23 After Positive Phase 3 SHASTA-3 and SHASTA-4 Topline Data for Plozasiran (25 mg Subcutaneous Every Three Months) Showed 79% and 81% Median Reductions in Triglyceride Levels at 12 Months Versus Approximately 27% for Placebo in Adults With Severe Hypertriglyceridemia, With Statistically Significant Reductions in Acute Pancreatitis Events Across Both Trials; Arrowhead Plans to File a Supplemental New Drug Application With the FDA Before End of 2026

Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported positive Phase 3 topline results Thursday July 23, 2026 from the SHASTA-3 and SHASTA-4 studies of plozasiran, an ApoC-III-targeting siRNA administered as a 25 mg subcutaneous injection once every three months, in adults with severe hypertriglyceridemia (sHTG). Both trials met their primary endpoint: median triglyceride reductions of 79% (SHASTA-3) and 81% (SHASTA-4) at Month 12 versus approximately 27% for placebo. All prespecified secondary endpoints were met, including a statistically significant reduction in the rate of acute pancreatitis events compared with placebo. Arrowhead shares rose approximately 19% on the readout. The company plans to file a supplemental New Drug Application (sNDA) with the US FDA before the end of 2026 for the sHTG indication (which extends the current Redemplo label from familial chylomicronemia syndrome), and Arrowhead intends to use the SHASTA-3, SHASTA-4, and MUIR-3 program data for marketing authorization filings across multiple global geographies. Plozasiran is a nucleic-acid therapeutic (siRNA), an adjacent-modality to peptides that operates through RNA interference at the ApoC-III gene expression level to lower circulating triglycerides.