Peptide News Digest

Wegovy 7.2 mg 28% Early Responders ECO, CagriSema 35.7% Fat Mass Loss, Mounjaro Overtakes Keytruda, Foundayo UAE Launch, Tonix Q1 + Entera EB613

ECO 2026 opens: Wegovy 7.2 mg 28% early responders, CagriSema body composition, Foundayo UAE, Tonix Q1, Entera EB613, Oncopeptides Pepaxti EMA.

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

Editor's Note

The 33rd European Congress on Obesity opened in Istanbul Tuesday with Novo Nordisk anchoring the headline cycle. The company released two same-day analyses: in the STEP UP early-responder post-hoc, 27% of patients on the higher-dose 7.2 mg formulation reached ≥15% weight loss by week 24 and went on to lose a mean 27.7% at week 72; and a separate post-hoc plus 34,000-woman real-world database showed weight loss is independent of menopausal stage (22.6% premenopausal, 19.7% perimenopausal, 19.8% postmenopausal) with a 42-45% reduced migraine risk and 25% reduced depression risk six months in. The CagriSema REDEFINE 1 body-composition substudy added that the 22.7% topline weight loss in 250 patients translated to a 35.7% fat-mass reduction vs only 14.4% lean-tissue reduction — the fat-selective pattern that has dominated the cagrilintide pitch. Bloomberg's May 6 framing of Mounjaro overtaking Keytruda as the world's #1 best-selling drug ($8.66B Q1 Mounjaro vs $7.9B Keytruda) crystallized in the May 12 industry analyst cycle. On the non-GLP-1 side, Eli Lilly's Foundayo (orforglipron) reached UAE pharmacies May 12 priced from AED 773 to AED 1,599 across the dose strengths; Tonix Pharmaceuticals reported Q1 2026 with TONMYA hitting $3.7M in launch revenue and TNX-1900 intranasal oxytocin advancing four Phase 2 studies (binge eating, adolescent obesity, bone health in autism, AVP deficiency); Entera Bio mapped a 750-patient Phase 3 program for EB613 (oral PTH 1-34) in postmenopausal osteoporosis with topline H2 2028. Oncopeptides announced an EMA Type II Variation submission for Pepaxti (melflufen) to expand the peptide-drug conjugate label to third-line multiple myeloma. Beyond commercial news, real-world ECO 2026 analyses surfaced just 8.1% three-year persistence on anti-obesity medications per Prime Therapeutics — a counterweight to the 22-28% efficacy headlines. Joelle Pelletier's Science Perspective from May 8 framed the Merck enlicitide biocatalytic synthesis as a template for the entire oral macrocyclic peptide modality.

Clinical Trials

Novo Nordisk ECO 2026 (May 12): Higher-Dose Wegovy 7.2 mg Drives 28% Weight Loss in Early Responders — 27% of Patients Cross the 15%-at-24-Week Threshold

A post-hoc analysis of the Phase 3 STEP UP trial presented Tuesday May 12 at ECO 2026 identified an 'early responder' subgroup — patients who lost at least 15% body weight within the first 24 weeks. About 27% of patients on the higher-dose Wegovy 7.2 mg dose met that threshold vs 21% on the 2.4 mg dose and 3% on placebo. Early responders went on to lose a mean 27.7% body weight at week 72 (vs the 21% headline mean across all 7.2 mg patients). The analysis also confirmed that 84% of weight loss across both Wegovy doses came from fat mass, with muscle function preserved. The data sharpens the case for early-response-based dose decisions in the post-launch real-world workflow.

#novo-nordisk #wegovy #semaglutide-7-2 #step-up #eco-2026 #early-responders #fat-mass #post-hoc-analysis
Clinical Trials

Novo Nordisk ECO 2026 (May 12): Wegovy Weight Loss Independent of Menopausal Stage + 34,000-Woman Real-World Database Shows 42-45% Migraine and 25% Depression Risk Reduction

A second post-hoc analysis of STEP UP presented Tuesday found Wegovy 7.2 mg delivered consistent weight loss across reproductive life stages: 22.6% premenopausal, 19.7% perimenopausal, 19.8% postmenopausal, with 41.4% of premenopausal women hitting ≥25% loss. Waist-circumference reductions: 17.5%, 15.6%, 15.3% respectively. Separately, a real-world analysis of 34,000+ women showed that those taking Wegovy had a 42-45% lower migraine risk and a 25% lower depression risk starting six months in versus those on menopausal hormone therapy alone. The real-world data lands as observational signals that warrant prospective study — not as proof of causation — but reinforces the cardiovascular and quality-of-life narrative for the women's-health subgroup.

#novo-nordisk #wegovy #menopause #women-health #migraine #depression #eco-2026 #real-world-evidence
Clinical Trials

CagriSema REDEFINE 1 Body Composition Substudy at ECO 2026: 35.7% Fat Mass Loss vs 14.4% Lean Tissue Loss in 252 Patients

A prespecified body-composition substudy of REDEFINE 1 presented at ECO 2026 reported that 252 participants on CagriSema 2.4 mg/2.4 mg (semaglutide + cagrilintide) achieved a 35.7% relative reduction in fat mass and a 14.4% reduction in lean soft-tissue mass at week 68 — compared with 5.7% and 4.3% on placebo. The headline 22.7% mean weight reduction in REDEFINE 1 (NEJM publication June 2025) thus broke down with a fat-mass-to-lean-tissue ratio of roughly 2.5:1, a more favorable body-composition profile than the typical 1.5-2:1 ratio reported for GLP-1 monotherapy. The data builds the case for combination amylin-GLP-1 therapy as preferentially fat-selective.

#cagrisema #redefine-1 #body-composition #fat-mass #cagrilintide #amylin #eco-2026 #novo-nordisk
Industry

Mounjaro Overtakes Keytruda as World's Top-Selling Drug — $8.66B Lilly Q1 vs $7.9B Merck Q1, Ending Keytruda's Two-Year Reign

Bloomberg reported May 6 that Eli Lilly's Mounjaro displaced Merck's Keytruda as the world's best-selling pharmaceutical in Q1 2026 — $8.66B Mounjaro Q1 sales vs Keytruda's $7.9B Q1 sales. The Mounjaro+Zepbound combined tirzepatide platform generated $36.5B in 2025, outpacing Keytruda's $31.6B. Keytruda had held the #1 ranking since Q1 2023, when it displaced AbbVie's Humira. The shift is the first time a peptide therapeutic has taken the top spot since the historical run of insulin biosimilars. The narrative also frames Lilly's $4.5B Lebanon Indiana manufacturing recommitment and the broader $21B Indiana capital plan as the supply-chain answer to demand at that scale.

#mounjaro #keytruda #eli-lilly #merck #tirzepatide #world-rankings #q1-2026
Industry

Foundayo Reaches UAE Pharmacies May 12: Dubai + Abu Dhabi Coverage at AED 773-1,599 Self-Pay Across Dose Strengths

Eli Lilly's Foundayo (orforglipron) reached UAE pharmacies on May 12 in Abu Dhabi, expanding from the April Dubai launch. The Emirates Drug Establishment first approved Foundayo on April 3, making the UAE the second country globally to register the once-daily oral GLP-1 pill. Pricing runs from AED 773/month for the 0.8 mg starter dose to AED 1,599/month for the 17.2 mg highest dose. Abu Dhabi has folded Foundayo into the emirate's broader weight-loss program, signaling government coverage rather than purely self-pay. The launch is one of the first international rollouts since FDA approval April 1; Lilly executives have framed UAE prescribing patterns and patient adherence as an early read on geriatric and Middle East regional patient response.

#foundayo #orforglipron #eli-lilly #uae #dubai #abu-dhabi #international-launch #pricing
Clinical Trials

Tonix Pharmaceuticals Q1 2026: TONMYA Hits $3.7M Launch Revenue, TNX-1900 Intranasal Oxytocin Pipeline Spans Binge Eating, Adolescent Obesity, Bone Health, AVP Deficiency

Tonix Pharmaceuticals reported Q1 2026 May 11 with $6.9M total net product revenue and a $40.2M net loss. TONMYA (cyclobenzaprine HCl sublingual tablet for fibromyalgia) generated $3.7M in its first full commercial quarter on 5,400 prescriptions filled and 2,145 prescribing HCPs. The peptide-relevant pipeline continues to anchor on TNX-1900, an intranasal potentiated oxytocin candidate now in four Phase 2 investigator-initiated studies at Mass General Hospital and the University of Virginia: binge-eating disorder, adolescent obesity, bone health in autism spectrum disorder, and arginine vasopressin deficiency. The portfolio represents one of the few clinical-stage neuropeptide programs outside the GLP-1 axis, with potential applications across psychiatric, metabolic, and rare endocrine indications.

#tonix-pharmaceuticals #tnx-1900 #oxytocin #binge-eating #adolescent-obesity #tonmya #q1-2026 #neuropeptide
Clinical Trials

Entera Bio Q1 2026: EB613 Oral PTH(1-34) Tablet Phase 3 Plan Submitted to FDA, 750-Patient Postmenopausal Osteoporosis Trial Slated for Late 2026, Topline H2 2028

Entera Bio reported Q1 2026 May 8 with $20.4M cash and an updated Phase 3 plan for EB613, an oral once-daily PTH(1-34) tablet that would be the first oral osteoanabolic for postmenopausal osteoporosis. The streamlined Phase 3 protocol — submitted to the FDA in March — covers 750 postmenopausal women with primary endpoint of total hip BMD change from baseline at month 12. Trial initiation is targeted for late 2026, with topline H2 2028 — roughly one year earlier than previously guided. The molecule applies Entera's N-Tab oral peptide platform to teriparatide, the active ingredient in Forteo. The Phase 2 dose-ranging study in 161 patients met primary (PD/bone-turnover biomarker) and secondary (BMD) endpoints.

#entera-bio #eb613 #oral-peptide #pth #osteoporosis #postmenopausal #phase-3 #n-tab-platform
Regulatory

Oncopeptides Files EMA Type II Variation to Expand Pepaxti (Melflufen) Peptide-Drug Conjugate Label to Third-Line Multiple Myeloma

Oncopeptides AB announced May 11-12 it intends to submit a Type II variation application to the European Medicines Agency to expand the Pepaxti (melflufen) label to include third-line treatment of relapsed/refractory multiple myeloma. Pepaxti is one of two FDA-approved peptide-drug conjugates currently on market (the other being Novartis's 177Lu-dotatate Lutathera) and acts as a melphalan-flufenamide alkylating peptide that exploits aminopeptidase enzymes overexpressed in myeloma plasma cells to selectively release the cytotoxic payload inside tumor cells. The Pepaxti EMA label currently covers heavily pre-treated (≥4 prior lines) RRMM; the new third-line expansion submission would meaningfully extend the eligible population. The filing positions the PDC modality for a broader regulatory footprint as the broader peptide-drug-conjugate field heads into ASCO 2026.

#oncopeptides #pepaxti #melflufen #multiple-myeloma #peptide-drug-conjugate #ema #third-line #rrmm
Research

Real-World ECO 2026 Counterweight: Prime Therapeutics Claims Analysis Shows Just 8.1% Three-Year Persistence on Anti-Obesity Medications

Real-world data presented in the ECO 2026 cycle counters the trial-based efficacy headlines: a Prime Therapeutics commercial claims analysis (cited in the May 2026 Managed Healthcare Executive cover story) found just 8.1% of members persisted with anti-obesity GLP-1 medications for three years. A separate 6-month Medicaid persistence analysis showed roughly 61% staying on treatment at six months. The high attrition is driven primarily by GI tolerability, insurance turnover, and out-of-pocket costs after step-edit programs. For newer agents like semaglutide and tirzepatide, post-discontinuation weight regain averages 0.8 kg per month — projecting return to baseline by ~1.5 years. PBM programs (Optum Rx Weight Engage, Rightway, MedImpact GLP-1 Benefit 360) are now embedding multidisciplinary support to lift persistence above the current floor.

#real-world-evidence #glp-1-persistence #prime-therapeutics #discontinuation #pbm #eco-2026 #weight-regain
Research

Science Perspective (May 8): Pelletier Frames Merck Enlicitide Biocatalytic Cascade as a Template for the Entire Oral Macrocyclic Peptide Modality

Joelle Pelletier's perspective in Science (volume 392, pages 582-583, published online May 8) accompanies the Merck enlicitide biocatalytic synthesis paper and frames the enzyme-cascade route — engineered enzymes plus chromatography-free crystallization to cut step count by more than half — as a template that goes well beyond enlicitide. The piece argues that the limiting step for oral macrocyclic peptide therapeutics has been the manufacturing cost of multi-step protected-residue chemistry, not pharmacology or pharmacokinetics; biocatalysis collapses the cost curve and unlocks a pipeline of oral peptides at large molecular weights that have been quietly stuck in preclinical or Phase 1 economics. The framing matters as enlicitide (oral PCSK9 inhibitor with 57% LDL-C reduction at 24 weeks) heads toward NDA filing.

#science-journal #pelletier #perspective #enlicitide #merck #macrocyclic-peptides #biocatalysis #oral-peptide