Peptide News Digest

EASO 2026 Nature Medicine Framework Update, CagriSema REDEFINE 1 ASCVD Risk, RESETTLE Young Adults 19% BMI, Mazdutide GLORY-2 18.55%, JPM Cuts Hims Target

ECO Day 3: EASO 2026 framework first-line tirzepatide/semaglutide, CagriSema CV risk, RESETTLE young adults, Mazdutide GLORY-2 18.55%, JPM/Canaccord Hims.

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

Editor's Note

ECO 2026 Day 3 in Istanbul anchored the obesity-pharmacology cycle on guidelines and combination-therapy data. The European Association for the Study of Obesity published an updated framework in Nature Medicine recommending semaglutide or tirzepatide as first-line therapy for obesity across most complications — with tirzepatide preferred for OSA and MASH, semaglutide preferred for knee osteoarthritis and cardiovascular disease (and the only one with current evidence for MASH-fibrosis improvement). The CagriSema REDEFINE 1 cardiovascular sub-analyses presented Thursday added depth to the body-composition story from Tuesday: 10.9 mmHg systolic blood pressure reduction at week 68 (vs 8.8 with semaglutide alone, 2.1 with placebo), a 68.9% drop in hsCRP (vs 55.4% with semaglutide, 16% placebo), and meaningful reductions in 10-year predicted atherosclerotic cardiovascular disease risk relative to the monotherapy and placebo arms. Wilding's Liverpool group also presented Thursday on real-world GLP-1 effectiveness across the BMI-reduction-tier breakdown. RESETTLE — a randomized trial of semaglutide in young adults aged 18-28 who remained severely obese after Holbæk Children's Obesity Clinic non-pharmacological care — produced 19% mean BMI reduction (22.3 kg) at 68 weeks, finally giving prescribers evidence for the treatment-resistant young-adult cohort. Innovent Biologics pre-announced the full ADA 2026 (June 5-8 New Orleans) mazdutide slate, including Phase 3 GLORY-2 (18.55% mean weight reduction at 60 weeks on 9 mg, 44% reaching ≥20%) and head-to-head DREAMS-3 (mazdutide superior to semaglutide on HbA1c + weight composite endpoint). On the commercial side, JPMorgan trimmed its Hims & Hers price target to $33 from $35 (Overweight, mixed-quarter framing) while Canaccord raised to $32 from $30 (Buy, transition speed bump) — a split call defining the post-Q1 stock picture. Novo CEO Mike Doustdar's May talks confirmed Wegovy pill surpassed 1 million US users 16 weeks post-launch. ASCO 2026 abstracts release May 21 with substantial peptide-oncology presence (Bicycle, Avacta, BioVaxys, BriaCell, Pfizer, Merck, Lilly), and the FDA bulks drug substances list was updated May 14. A Frontiers in Drug Delivery review by Niazi at UIC framed which peptides should not be developed orally — a negative-selection framework that pushes short-half-life and dose-sensitive peptides toward pulmonary, nasal, or long-acting injectable routes instead.

Research

EASO 2026 Framework Update (Nature Medicine, Presented ECO May 14): Semaglutide and Tirzepatide First-Line With Complication-Specific Algorithm

The European Association for the Study of Obesity published an updated pharmacological framework in Nature Medicine, presented at ECO 2026 in Istanbul on Thursday May 14. Semaglutide and tirzepatide are recommended as first-line treatment for obesity across most complications. Tirzepatide is preferred for obstructive sleep apnea and MASH; semaglutide is preferred for knee osteoarthritis and established cardiovascular disease — and is the only agent with current evidence supporting MASH-fibrosis improvement. The framework integrated evidence through November 21, 2025 from 62 randomized controlled trials. The algorithm uses obesity-related complication presence as the primary treatment-selection factor and provides the first major obesity-society guideline to formally privilege incretin-based therapy across the indication mix.

#easo #nature-medicine #semaglutide #tirzepatide #first-line-therapy #eco-2026 #treatment-guidelines
Clinical Trials

CagriSema REDEFINE 1 ASCVD Risk + hsCRP + SBP Sub-analyses Presented ECO 2026 Day 3 (May 14)

Novo Nordisk's CagriSema REDEFINE 1 cardiovascular sub-analyses, presented at ECO 2026 on Thursday May 14, layered onto the May 12 body-composition data. At week 68, CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) reduced systolic blood pressure by 10.9 mmHg vs 8.8 with semaglutide alone and 2.1 with placebo. High-sensitivity C-reactive protein dropped 68.9% vs 55.4% (semaglutide) and 16.0% (placebo). The 10-year predicted atherosclerotic cardiovascular disease risk decreased meaningfully on CagriSema versus all comparators, with fewer participants on CagriSema falling into the intermediate-to-high-risk category. The sub-analyses sharpen the combination-therapy case beyond the 22.7% mean weight-loss headline.

#cagrisema #redefine-1 #novo-nordisk #ascvd-risk #hscrp #systolic-blood-pressure #eco-2026
Clinical Trials

RESETTLE Trial (ECO 2026 May 13): Semaglutide 2.4 mg in 18-28 Year Olds With Treatment-Resistant Severe Obesity Drives 19% Mean BMI Reduction

Prof. Jens-Christian Holm and colleagues at the Children's Obesity Clinic (European Centre for Obesity Management at Holbæk Hospital) presented RESETTLE at ECO 2026 on May 13. The randomized trial enrolled young adults aged 18-28 who remained severely obese despite at least one year of hospital-based non-pharmacological treatment in childhood. After 68 weeks of once-weekly semaglutide 2.4 mg vs placebo, the treatment arm achieved 19% mean BMI reduction (22.3 kg average weight loss). Total fat mass, abdominal fat, and liver fat all improved substantially vs placebo. The data fills a clinical gap — most semaglutide weight-loss trials excluded young adults coming out of structured pediatric obesity programs, leaving prescribers without evidence for one of the most underserved cohorts.

#semaglutide #wegovy #young-adults #treatment-resistant-obesity #resettle #holbaek #eco-2026
Clinical Trials

Innovent Mazdutide Announces Full ADA 2026 Slate (May 12) — Phase 3 GLORY-2 18.55% Weight Loss + DREAMS-3 vs Semaglutide Head-to-Head

Innovent Biologics announced May 12 that it will present multiple clinical and preclinical results from mazdutide and its next-generation obesity & metabolic pipeline at the 2026 American Diabetes Association Scientific Sessions in New Orleans, June 5-8. Mazdutide is a GLP-1/glucagon dual agonist developed initially for the Chinese market. The Phase 3 GLORY-2 trial in Chinese adults with moderate-to-severe obesity reported a mean 18.55% weight reduction at 60 weeks on 9 mg dosing (vs ~3% placebo); 44% of GLORY-2 patients hit ≥20% body weight loss vs 2.5% on placebo. The Phase 3 head-to-head DREAMS-3 trial in T2D + obesity showed 48% of mazdutide patients hit HbA1c <7% + ≥10% weight loss vs 21% on semaglutide at week 32. The 9 mg dose is under NMPA review for approval in China. Mazdutide is the leading non-Lilly dual GLP-1/glucagon program competing with Boehringer's survodutide and earlier-stage Western programs.

#innovent #mazdutide #glory-2 #dreams-3 #glp-1-glucagon-dual #china #ada-2026
Industry

JPMorgan Cuts Hims & Hers Price Target to $33; Canaccord Raises to $32 — Split Calls on Post-Q1 GLP-1 Pivot

Wall Street's read of Hims & Hers' Q1 print delivered May 11 split between two camps. JPMorgan trimmed its price target to $33 from $35 (Overweight reaffirmed) on what analysts called a 'mixed' quarter, citing gross margin compression from 73% to 65% on the wind-down of compounded semaglutide. Canaccord raised its target to $32 from $30 (Buy) framing the quarter as a transition speed bump rather than a thesis break. The central question both calls land on: whether branded Novo Nordisk Wegovy/Ozempic distribution (live since March 26) can offset margin loss from the compounded business. Q1 books closed March 31, so meaningful Wegovy revenue contribution comes in Q2; subscriber count held at 2.6M (+9% YoY).

#hims-hers #jpmorgan #canaccord #q1-2026 #price-target #wegovy #ozempic #compounding
Industry

Wegovy Pill Surpasses 1 Million US Users 16 Weeks Post-Launch — Novo CEO Doustdar

Novo Nordisk CEO Mike Doustdar confirmed on the May 6 Q1 analyst call and in May 14 follow-up commentary that the Wegovy pill has surpassed 1 million cumulative US users 16 weeks after the January 5, 2026 launch. The pill posted DKK 2.26B (~$354M) in Q1 sales (nearly 2x analyst consensus) on roughly 1.3 million Q1 prescriptions. Wegovy now holds 65% of all new US GLP-1 prescriptions per the Q1 IQVIA data. International expansion is targeted for H2 2026 with EU approval anticipated before year-end. The pill ramp is the cleanest near-term commercial signal for Novo against Lilly's tirzepatide franchise (Mounjaro/Zepbound), which displaced Keytruda as the world's #1 best-selling drug in Q1 2026.

#novo-nordisk #wegovy-pill #oral-semaglutide #doustdar #launch-tracker #1-million-users
Industry

ASCO 2026 Abstract Release Set for May 21 — Peptide Oncology Curtain Raiser

ASCO 2026 abstracts will release on asco.org/abstracts beginning 5:00 PM ET on Wednesday May 21, ahead of the May 29-June 2 Chicago meeting. The peptide-oncology slate is substantial: Pfizer announced 40+ company-sponsored, investigator-sponsored, and collaborative oncology abstracts including three late-breaking sessions; Bicycle Therapeutics has an oral and four poster presentations on zelenectide pevedotin (BT8009, nectin-4 PDC) with Duravelo-2 interim data; Avacta has Phase Ia/Ib data on AVA6000 (FAP-Dox PDC) in salivary gland cancers; BioVaxys's MVP-S survivin peptide vaccine PESCO trial data; BriaCell's six Bria-IMT/Bria-OTS+ presentations on metastatic breast cancer; and Replimune's RP1 + nivolumab 3-year melanoma OS data. Crinetics CRN09682 SSTR2 NDC BRAVESST2 update expected.

#asco-2026 #peptide-oncology #bicycle-therapeutics #avacta #biovaxys #briacell #pfizer #merck
Regulatory

FDA Bulks Drug Substances List Updated May 14, 2026 — Ongoing Compounding-Status Rolling Updates Ahead of July 23-24 PCAC

The FDA updated its Section 503A bulks drug substances list on May 14, 2026, continuing the rolling-status changes leading into the July 23-24 PCAC meeting that will evaluate seven peptides (BPC-157, KPV, TB-500, MOTs-C on Day 1; Emideltide/DSIP, Semax, Epitalon on Day 2) for potential 503A-bulks-list inclusion. The April 30 503B bulks-list proposal (closing June 29) is moving in parallel toward effectively ending large-scale 503B compounding of semaglutide, tirzepatide, and liraglutide. The combined regulatory cycle through July 24 will reshape the compounding-pharmacy economy for the next 2-3 years and determine which research peptides remain accessible through licensed channels.

#fda #503a-bulks-list #503b-bulks-list #compounding #pcac #peptide-policy
Research

ECO 2026 Day 3 Cagrilintide Monotherapy DXA Body Composition Subgroup — 62.9% Fat Mass Selectivity

A second body-composition substudy from REDEFINE 1 presented May 14 at ECO 2026 broke out the DXA subgroup by treatment arm. At week 68, CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) produced -23.9% weight reduction in the DXA subgroup, compared with -16.6% on semaglutide 2.4 mg alone, -15.0% on cagrilintide 2.4 mg alone, and -2.8% on placebo. The fat-mass-to-lean-tissue ratios were favorable across all active arms: 66.9% fat-mass contribution on CagriSema, 69.7% on semaglutide, 62.9% on cagrilintide. The cagrilintide monotherapy arm is the first head-to-head body-composition signal for amylin-only therapy at clinically meaningful weight-loss levels — relevant to Zealand and Roche's petrelintide Phase 3 program and the broader amylin-versus-incretin debate.

#cagrisema #cagrilintide #amylin #dxa #body-composition #eco-2026 #novo-nordisk
Research

Frontiers in Drug Delivery: Niazi at UIC Proposes Negative-Selection Framework for Oral Peptide Therapeutics

Sarfaraz K. Niazi at the University of Illinois Chicago College of Pharmacy published a March 20, 2026 review in Frontiers in Drug Delivery arguing oral peptide delivery success depends fundamentally on molecular pharmacology rather than formulation technology. The thesis: semaglutide's approval represents a rare boundary case enabled by its ~168-hour half-life and time-integrated pharmacodynamics, not a generalizable breakthrough. The author proposes a negative-selection framework identifying which peptides should be excluded from oral development — short elimination half-lives, dose sensitivity, regulatory variability constraints — and routes excluded candidates toward pulmonary, nasal, or long-acting injectable alternatives. The framework matters for the next-generation pipeline beyond Foundayo and Wegovy pill: many programs currently chasing oral delivery may be better served by alternative routes.

#niazi #frontiers #oral-peptide-delivery #negative-selection #pharmacokinetics #drug-delivery #uic