Peptide News Digest

EASL 2026 Day 2: Altimmune Pemvidutide 48-Week Oral Data, Boehringer Survodutide NEJM MASH, Aligos ALG-055009 46% Liver Fat, Mayo Folate Receptor Vaccine TNBC, Roswell GLP-1 Breast Cancer ASCO

EASL Day 2: pemvidutide 48-week oral data, survodutide NEJM MASH 47-62%, Aligos ALG-055009 46% liver fat, Mayo folate-receptor vaccine TNBC, Roswell GLP-1 breast cancer.

10 stories · Covering clinical-trials, research, industry, regulatory

Editor's Note

EASL 2026 Day 2 in Barcelona delivered the meeting's headline obesity-peptide readout: Altimmune presented the full Week 48 IMPACT Phase 2b oral data for pemvidutide today at 17:00 CEST (Dr. Mazen Noureddin, Houston Methodist), with the 1.8 mg dose cutting triglycerides 23.7%, total cholesterol 15.4%, body weight 7.5%, BMI 3.0 kg/m², and waist circumference 5.3 cm, plus blood pressure reduction, at 1% discontinuation. The abstract carried 'Best of EASL 2026' selection. Boehringer Ingelheim's survodutide full 48-week Phase 2 MASH data published simultaneously in NEJM — the GLP-1/glucagon dual agonist drove MASH improvement without fibrosis worsening in 47%, 62%, and 43% of the 2.4 mg, 4.8 mg, and 6.0 mg groups versus 14% on placebo, with up to 52% achieving fibrosis-stage improvement; the LIVERAGE and LIVERAGE-Cirrhosis Phase 3 trials (1,800 and ~1,590 patients) are enrolling. Aligos Therapeutics presented across ten EASL slots, headlined by ALG-055009 (THR-β agonist small molecule) hitting up to 46.2% placebo-adjusted MRI-PDFF liver-fat reduction at week 12 plus pevifoscorvir sodium HBV cccDNA-reservoir data. On the non-GLP-1 oncology side ahead of ASCO 2026 (opening tomorrow in Chicago), Mayo Clinic's randomized Phase 2 folate receptor alpha peptide vaccine (TPIV200) in triple-negative breast cancer and a Roswell Park GLP-1-and-aggressive-breast-cancer analysis anchor the peptide-and-metabolic oncology slate. The combined EASL + pre-ASCO cycle keeps MASH and obesity oncology as the dominant 2026 peptide narratives.

Clinical Trials

Altimmune Pemvidutide IMPACT Phase 2b Week 48 Oral Presentation (May 28, 17:00 CEST): 1.8 mg Dose Cuts Triglycerides 23.7%, Total Cholesterol 15.4%, Weight 7.5%, Waist 5.3 cm at ~1% Discontinuation

Altimmune presented the full Week 48 top-line IMPACT Phase 2b oral data for pemvidutide in MASH today at EASL 2026 Barcelona (Dr. Mazen Noureddin, Houston Methodist Hospital, 17:00 CEST). The 1.8 mg dose reduced triglycerides 23.7%, total cholesterol 15.4%, body weight 7.5%, BMI 3.0 kg/m², and waist circumference 5.3 cm, alongside blood pressure reduction. Safety held at 48 weeks with roughly 1% discontinuation due to adverse events and mostly mild-to-moderate gastrointestinal events. Previously reported: 27.8% (1.2 mg) and 32.4% (1.8 mg) of patients achieved combined ELF and LSM improvements versus 3.2% on placebo. The 48-week analysis carries the 'Best of EASL 2026' designation. Pemvidutide is a balanced 1:1 GLP-1/glucagon dual receptor agonist peptide with FDA Fast Track + Breakthrough Therapy Designations for MASH. The cardiometabolic-risk-factor profile positions pemvidutide as differentiated on the lipid and cardiovascular axis versus pure GLP-1 agonists.

#altimmune #pemvidutide #impact-trial #easl-2026 #week-48 #glp-1-glucagon #mash #cardiometabolic #noureddin
Clinical Trials

Boehringer Ingelheim Survodutide Full 48-Week Phase 2 MASH Data in NEJM (EASL 2026): GLP-1/Glucagon Dual Agonist Drives MASH Improvement Without Fibrosis Worsening in 47-62% vs 14% Placebo

Boehringer Ingelheim's survodutide full 48-week Phase 2 MASH dataset published in the New England Journal of Medicine alongside the EASL 2026 presentation. MASH improvement without worsening of fibrosis occurred in 47% of the 2.4 mg group, 62% of the 4.8 mg group, and 43% of the 6.0 mg group, versus 14% on placebo. Up to 52% of survodutide-treated adults achieved significant improvement across fibrosis stages F1, F2, and F3 versus around 26% on placebo. Survodutide is an investigational long-acting glucagon/GLP-1 receptor dual agonist (BI 456906, partnered with Zealand Pharma) for once-weekly subcutaneous administration. The Phase 3 program is advancing through LIVERAGE (~1,800 adults with MASH F2-F3) and LIVERAGE-Cirrhosis (~1,590 adults with compensated MASH cirrhosis F4). Survodutide also posted 16.6% weight loss in the SYNCHRONIZE-1 obesity Phase 3 (April 2026). The NEJM publication is the strongest peer-reviewed validation of the GLP-1/glucagon dual mechanism in MASH to date.

#boehringer-ingelheim #survodutide #zealand-pharma #nejm #mash #glp-1-glucagon #liverage #easl-2026
Clinical Trials

Aligos Therapeutics EASL 2026 Ten-Presentation Slate: ALG-055009 THR-β Agonist Hits 46.2% Placebo-Adjusted Liver-Fat Reduction at Week 12; Pevifoscorvir Sodium Reduces HBV cccDNA Reservoir

Aligos Therapeutics presented positive data across ten presentations at EASL 2026 Barcelona. The headline MASH data: ALG-055009, a THR-β (thyroid hormone receptor beta) agonist small molecule, met its primary endpoint in the Phase 2a HERALD study with robust liver-fat reduction at week 12 — doses of 0.5 mg to 0.9 mg achieving statistically significant reductions with placebo-adjusted median relative reductions up to 46.2% as measured by MRI-PDFF. On the viral hepatology side, Aligos presented Phase 1 data on pevifoscorvir sodium suggesting a reduced cccDNA reservoir in chronic HBV patients, with an investigator-led study showing ≥24-week follow-up in HBeAg+ participants after 96 weeks of monotherapy. The combined slate spans the Aligos chronic HBV, HDV, MASH, and liver cancer pipeline. The ALG-055009 THR-β mechanism puts Aligos in direct competition with Madrigal's Rezdiffra (resmetirom), the only FDA-approved MASH therapy, on the same receptor target.

#aligos-therapeutics #alg-055009 #thr-beta #pevifoscorvir #mash #hbv #cccdna #easl-2026
Clinical Trials

Mayo Clinic Folate Receptor Alpha Peptide Vaccine (TPIV200) Randomized Phase 2 in Triple-Negative Breast Cancer — ASCO 2026 Abstract 536, June 1 Presentation

Mayo Clinic researchers led by Dr. Kathryn Ruddy will present a randomized Phase 2 trial of the folate receptor alpha (FRα) peptide vaccine TPIV200 in early-stage triple-negative breast cancer at ASCO 2026 (Abstract 536, June 1, 1:30-4:30 PM CDT). The trial dosed 80 patients with vaccine; 58 were evaluable for immunogenicity. The TPIV200 multi-epitope FRα peptide vaccine was found safe and immunogenic using a single low-dose injection without cyclophosphamide priming. FRα is overexpressed on the cell surface in breast, ovarian, and lung cancers, making it a shared-antigen vaccine target distinct from personalized neoantigen approaches. The data supports combining TPIV200 with an immune checkpoint inhibitor to extend recurrence-free or progression-free survival in TNBC — the breast cancer subtype with the highest mortality risk and fewest targeted-therapy options. The vaccine adds to the peptide cancer vaccine cohort (BioVaxys MVP-S, Dana-Farber NeoVax, Greenwich GP2) at ASCO 2026.

#mayo-clinic #tpiv200 #folate-receptor-alpha #peptide-vaccine #triple-negative-breast-cancer #asco-2026 #shared-antigen
Research

Roswell Park ASCO 2026 GLP-1 and Aggressive Breast Cancer Analysis — Real-World Data on GLP-1 Receptor Agonist Effects in High-Risk Breast Cancer (Zunairah Shah)

Roswell Park Comprehensive Cancer Center will present an analysis at ASCO 2026 (May 29-June 2 Chicago) by Dr. Zunairah Shah on the effects of GLP-1 receptor agonists in aggressive breast cancer. The real-world study examines whether GLP-1 therapy — widely used for glucose control and weight loss — confers additional benefit in high-risk breast cancer outcomes. The analysis joins the broader ASCO 2026 GLP-1 oncology slate, which includes Abstract 3143 (the 12,112-patient analysis showing 38-50% lower metastatic progression across four obesity-related cancers, with breast cancer showing 10% vs 20% metastasis on GLP-1 vs gliptin and 45% lower mortality with high tumor GLP-1R expression). Roswell Park also presented a companion real-world analysis on protein-energy malnutrition outcomes in metastatic TNBC (Abstract 1135). The GLP-1-and-cancer signal is one of the most-watched emerging themes at ASCO 2026, expanding the GLP-1 indication conversation beyond cardiometabolic disease.

#roswell-park #glp-1-cancer #aggressive-breast-cancer #real-world-evidence #asco-2026 #obesity-oncology
Clinical Trials

Assembly Biosciences ABI-6250 Phase 1a Topline at EASL 2026: First-in-Class Oral HDV Entry Inhibitor — The Small-Molecule Competitor to Gilead's Just-Approved Bulevirtide Peptide

Assembly Biosciences presented topline Phase 1a data on ABI-6250 at EASL 2026 (poster WED-579, Dr. Edward Gane, University of Auckland) — a first-in-class oral hepatitis D virus (HDV) entry inhibitor. The Phase 1a study evaluated safety, pharmacokinetics, and pharmacodynamic activity in healthy participants; the data supports advancing directly into a Phase 2 study by year-end. ABI-6250 is the only oral entry inhibitor in development for chronic HDV. The mechanistic context matters: Gilead's Hepcludex (bulevirtide) — a 47-amino-acid injectable lipopeptide NTCP entry inhibitor — just won FDA accelerated approval May 22 as the first US HDV treatment. ABI-6250 targets the same entry-inhibition step but as an oral small molecule rather than an injectable peptide, positioning it as a potential next-generation convenience competitor in the small but newly-validated HDV market. Assembly also announced May 22 an expansion of ABI-6250 development into cholestatic liver diseases. The peptide-vs-small-molecule dynamic in HDV mirrors the same competition that played out in GLP-1 (injectable semaglutide vs oral orforglipron).

#assembly-biosciences #abi-6250 #hdv #entry-inhibitor #bulevirtide #oral-small-molecule #easl-2026
Industry

EASL 2026 MASH Mechanism Map After Day 2 — GLP-1/Glucagon Peptides vs THR-β Agonism vs RNAi vs FASN Inhibition vs FGF21 Analogs

EASL 2026's first two days clarified the MASH-therapeutics competitive map across five mechanism classes. GLP-1/glucagon dual peptides: Altimmune pemvidutide (48-week IMPACT data, Best of EASL), Boehringer survodutide (NEJM 47-62% MASH improvement, LIVERAGE Phase 3), MetaVia DA-1726 (48 mg Phase 1). THR-β agonists: Madrigal Rezdiffra (only FDA-approved MASH therapy, eight EASL posters), Aligos ALG-055009 (46.2% liver-fat reduction Phase 2a). RNAi: Arrowhead ARO-INHBE (Activin E/ALK7, 44% liver fat, tirzepatide combination). FASN inhibition: Sagimet denifanstat + Rezdiffra combination. FGF21 analogs: the Akero efruxifermin (Novo $5.2B acquisition) and 89bio pegozafermin (Roche $3.5B acquisition) programs anchoring the most-acquired MASH mechanism. Plus galectin-3 inhibition (Galectin belapectin NAVIGATE) and pan-PPAR agonism (Inventiva lanifibranor NATiV3 Phase 3). The GLP-1/glucagon peptide class leads on combined weight-loss-plus-liver effect; the FGF21 and THR-β classes lead on pure antifibrotic mechanism. Combination therapy across mechanism classes is the emerging 2026 thesis.

#easl-2026 #mash #mechanism-map #glp-1-glucagon #thr-beta #fgf21 #competitive-landscape
Industry

Novo Nordisk ESSENCE Real-World MASH Burden Data at EASL 2026 Day 2: Quality-of-Life Impairment and Healthcare-Cost Escalation Quantified Alongside Semaglutide Subgroup Analyses

Novo Nordisk extended its EASL 2026 ESSENCE presentation cycle into Day 2 with real-world evidence quantifying the MASH disease burden — documenting significant quality-of-life impairment and escalating healthcare costs in MASH patients — alongside the Japanese MASH and menopausal women subgroup analyses presented Day 1. The data builds the health-economic case for semaglutide 2.4 mg following the August 2025 FDA MASH-with-fibrosis approval. MASH affects roughly 1 in 3 people living with overweight or obesity worldwide, with the majority undiagnosed. Novo's 'Love Your Liver' EASL initiative offered on-site MASH testing for attendees. The real-world burden data complements the ESSENCE Phase 3 efficacy story by establishing the economic and quality-of-life rationale for early MASH intervention — a payer-facing argument as the GLP-1 MASH indication scales into 2026-2027 against the THR-β, FGF21, and GLP-1/glucagon competitor classes.

#novo-nordisk #essence-trial #semaglutide #mash #real-world-evidence #health-economics #easl-2026
Industry

ASCO 2026 Opens Tomorrow (May 29 Chicago) — Peptide-Oncology Slate Anchored on Bicycle Duravelo-2, Avacta AVA6000, BriaCell Bria-IMT, Sapience Lucicebtide, Corbus CRB-701, Crinetics CRN09682, Aktis AKY-2519, Mayo TPIV200

The ASCO 2026 Annual Meeting opens tomorrow Friday May 29 at McCormick Place Chicago, running through June 2. The peptide-and-targeted-conjugate oncology slate that landed in the May 21 abstract release and the May 26 embargoed press briefing: Bicycle Therapeutics Duravelo-2 Phase 2 (zelenectide pevedotin 65% ORR / 58% BICR-confirmed in 1L urothelial, oral June 1 8:30 AM); Avacta AVA6000 FAP-Dox Phase 1a/1b in salivary gland (90% disease control); BriaCell Bria-IMT 16.6-month median OS in metastatic breast cancer; Sapience lucicebtide 28.4-month projected median PFS in glioblastoma; Corbus CRB-701 Nectin-4 ADC in HNSCC and cervical (oral May 29); Crinetics CRN09682 SSTR2 non-peptide drug conjugate BRAVESST2; Aktis AKY-2519 B7-H3 miniprotein radioconjugate; Mayo Clinic TPIV200 folate-receptor peptide vaccine in TNBC; plus the GLP-1 cancer slate (Abstract 3143, Roswell Park breast cancer). ASCO 2026 follows immediately after EASL 2026 closes May 30 — the back-to-back meeting structure makes the May 27-June 2 window the highest-density peptide-data week of 2026.

#asco-2026 #peptide-oncology #bicycle-therapeutics #avacta #briacell #sapience-therapeutics #corbus-pharmaceuticals #chicago
Regulatory

FDA Peptide Compounding Reclassification Status Check Ahead of July 23-24 PCAC — Seven Peptides (BPC-157, TB-500, Epitalon, Semax, KPV, MOTs-C, Emideltide/DSIP) Pending 503A Bulks-List Decision

With EASL and ASCO dominating the clinical-data cycle, the FDA peptide-compounding regulatory track continues moving toward the July 23-24, 2026 Pharmacy Compounding Advisory Committee (PCAC) meeting. Twelve peptides came off the FDA Category 2 'significant safety risk' bulks list effective April 23, 2026; seven of those (BPC-157, TB-500, KPV, MOTs-C on Day 1; Emideltide/DSIP, Semax, Epitalon on Day 2) advance to the July PCAC for affirmative 503A bulks-list inclusion. A second PCAC before end of February 2027 reviews five more (GHK-Cu injectable, Melanotan II, Cathelicidin LL-37, Dihexa, PEG-MGF). Removal from Category 2 does not yet permit compounding — that requires the affirmative PCAC recommendation plus FDA final determination (6-12 month timeline). The parallel 503B bulks-list proposal excluding semaglutide, tirzepatide, and liraglutide closes public comments June 29. The compounded-semaglutide shipment volume is down 90% year-over-year per the BSR Intelligence briefing as the regulatory vise tightens on the gray-market segment.

#fda #pcac #503a-compounding #bpc-157 #tb-500 #epitalon #july-2026 #bulks-list