Peptide News Digest

Lilly Q1 Beats With $8.7B Mounjaro Quarter, FDA 503B GLP-1 Compounding Proposal, UTHealth BLMP6 Fibulin-4 Cancer Peptide, Crinetics Palsonify EU Approval

Lilly Q1 revenue jumps 56% as Mounjaro and Zepbound surge, FDA proposes 503B compounding ban for GLP-1s, UTHealth's BLMP6 hits fibulin-4 in metastatic TNBC, and Crinetics wins EU acromegaly approval.

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

Editor's Note

Two industry-shaping events anchor today's digest: Eli Lilly's Q1 2026 earnings beat, with $19.8 billion in revenue and a $2 billion guidance raise on the back of Mounjaro's $8.66B quarter and Zepbound's $4.16B U.S. run, and the FDA's proposal to strike semaglutide, tirzepatide, and liraglutide from the 503B outsourcing-facility bulks list — a regulatory win for Novo and Lilly that effectively ends large-scale compounding of branded GLP-1 actives once the 60-day comment window closes June 29. Beyond GLP-1s, the non-weight-loss peptide pipeline pushed forward with a UTHealth Houston Molecular Therapy Oncology paper showing the AI-discovered peptide BLMP6 binds fibulin-4 selectively on metastatic triple-negative breast cancer cells, a Nature paper from the DiMarchi/Tschöp group describing a unimolecular GLP-1R-GIPR-PPARα/γ/δ quintuple agonist that reverses obesity and diabetes in mice, a Nature Communications few-shot AI pipeline that designs antimicrobial peptides against Acinetobacter baumannii, and Crinetics' first regulatory approval outside the U.S. for the once-daily oral somatostatin receptor 2 agonist Palsonify in acromegaly. A Stanford-led Genome Medicine paper added another layer to the GLP-1 personalization conversation by identifying PAM-enzyme variants that may explain why roughly one in ten people get a weaker glycemic response to incretin drugs.

Industry

Eli Lilly Q1 2026 Beats: Revenue Up 56% to $19.8B, Mounjaro $8.66B (+125%), Zepbound $4.16B (+80%), 2026 Guidance Raised to $82–85B

Eli Lilly reported Q1 2026 worldwide revenue of $19.8 billion, up 56% year over year on 65% volume growth partially offset by a 13% price decline. Mounjaro hit $8.66 billion globally (+125%), Zepbound delivered $4.16 billion in U.S. sales (+80%), and reported Q1 EPS jumped 170% to $8.26. Lilly raised 2026 revenue guidance by $2 billion at each end to $82–85 billion and lifted non-GAAP EPS guidance to $35.50–$37.00. The release also recapped five positive Phase 3 readouts, six new Phase 3 starts, and the closings of the Orna, Centessa, Colonia, and Ajax acquisitions in the quarter.

#eli-lilly #q1-2026-earnings #mounjaro #zepbound #guidance-raise #tirzepatide
Regulatory

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide From 503B Bulks List, Citing 'No Clinical Need'

The FDA announced a proposal on April 30 to exclude semaglutide, tirzepatide, and liraglutide from the 503B outsourcing-facility bulks list, finding no clinical need for large-scale compounding now that branded supply has stabilized. Commissioner Marty Makary said outsourcing facilities cannot lawfully compound from bulk substances when FDA-approved drugs are available unless a clear clinical need exists. Public comments are open through June 29, 2026. The proposal targets 503B outsourcing facilities only and does not directly affect 503A patient-specific compounding, but it forecloses the largest legal pathway for branded-active GLP-1 compounding.

#fda #503b #compounding #semaglutide #tirzepatide #liraglutide
Research

UTHealth Houston BLMP6 Peptide Selectively Binds Fibulin-4 in Metastatic Triple-Negative Breast Cancer

Mikhail Kolonin's group at UTHealth Houston published preclinical data showing BLMP6, a peptide identified through AI-guided modeling, selectively binds fibulin-4 — a protein highly expressed on metastatic triple-negative breast cancer cells — and not on noninvasive breast cancer or normal breast tissue. A BLMP6 conjugate carrying monomethyl auristatin E suppressed metastasis and improved survival in mouse models, and BLMP6-based fluorescent imaging probes successfully detected metastatic lesions. The paper, published in Molecular Therapy Oncology, identifies fibulin-4 as a new theranostic target.

#blmp6 #fibulin-4 #uthealth-houston #triple-negative-breast-cancer #peptide-drug-conjugate #ai-discovery
Research

Nature Communications: Few-Shot AI Pipeline Designs Antimicrobial Peptides Against Carbapenem-Resistant Acinetobacter baumannii

A Nature Communications paper describes a deep-learning pipeline that uses pre-trained protein language models combined with few-shot fine-tuning to identify antimicrobial peptides effective against Acinetobacter baumannii, a WHO critical-priority pathogen. The classification, ranking, and regression modules collaboratively prioritize candidates with high predicted activity, expanding the chemical space accessible to data-poor AMR targets. Lead candidates showed potent in vitro activity against carbapenem-resistant clinical isolates.

#antimicrobial-peptides #acinetobacter-baumannii #few-shot-learning #amr #ai-discovery #nature-communications
Research

Nature: Unimolecular GLP-1R/GIPR/PPARα/γ/δ Quintuple Agonist Conjugate Reverses Obesity and Insulin Resistance in Mice

A Nature paper from Liskiewicz, DiMarchi, Tschöp, Müller and colleagues introduces a unimolecular peptide-drug conjugate that combines a GLP-1R/GIPR co-agonist peptide with the pan-PPAR (α/γ/δ) agonist lanifibranor via a pH-sensitive linker. After receptor-mediated internalization, the linker cleaves and lanifibranor escapes to the nucleus to activate PPARs while the peptide moiety drives GLP-1R/GIPR signaling at the membrane. In obese, diabetic mice the conjugate produced greater weight loss and insulin sensitization than equimolar dosing of the unconjugated peptide and lanifibranor, without the typical PPAR-related cardiac and weight-gain safety signals.

#quintuple-agonist #peptide-drug-conjugate #glp-1 #gip #ppar #lanifibranor #obesity #dimarchi #tschoep
Clinical Trials

Journal of Nuclear Medicine: 195-Patient Study Finds SSTR Expression Largely Retained After PRRT Progression, Supporting Retreatment

A Journal of Nuclear Medicine study analyzed patterns of progression in 195 patients with gastroenteropancreatic neuroendocrine tumors treated with [177Lu]Lu-DOTATATE PRRT. Progression occurred in 107 patients (54.9%), most often in the liver (60.7%) followed by bone (25.3%). Post-progression somatostatin receptor PET imaging showed retained SSTR uptake in 59.7% of patients, increased uptake in 18.2%, and reduced uptake in 19.5%, indicating that the majority remain candidates for additional SSTR-targeted radioligand therapy. The dataset reinforces the clinical case for sequencing peptide radioligand therapies rather than abandoning the modality at first progression.

#prrt #lutathera #neuroendocrine-tumors #sstr #radioligand-therapy #journal-of-nuclear-medicine
Industry

AMA Publishes 'What Doctors Wish Patients Knew About Injectable Peptides' Amid Surging Wellness Demand

The American Medical Association published a consumer-facing primer on April 30 framing the safety risks of unregulated injectable peptides marketed online for weight loss, recovery, muscle growth, and anti-aging. Physicians quoted in the piece urge patients to push past social-media claims and discuss intended use with a clinician, noting that many products sold under wellness branding are not FDA-approved and may carry sterility, dosing, and interaction risks. The piece joins recent coverage from STAT, Scientific American, the Washington Post, ABC News affiliates, and Columbia Doctors as mainstream medicine reacts to the post-Category-2 environment.

#ama #injectable-peptides #patient-safety #consumer-education #wellness
Regulatory

Crinetics Wins European Commission Approval for Palsonify (Paltusotine), the First Once-Daily Oral SST2 Agonist for Acromegaly

Crinetics Pharmaceuticals announced April 27 that the European Commission approved Palsonify (paltusotine), a selectively-targeted somatostatin receptor type 2 nonpeptide agonist, as the first once-daily oral therapy for acromegaly in adults across all 27 EU member states plus three EEA countries. The approval rests on two pivotal Phase 3 trials in medical-naïve and previously treated patients, with diarrhea, abdominal pain, and nausea reported as the most common adverse reactions and no serious adverse events in the randomized portion. First launches are planned for Germany and Austria, marking Crinetics' first regulatory approval outside the U.S. and a competitive challenge to injectable somatostatin analogs.

#crinetics #palsonify #paltusotine #acromegaly #european-commission #somatostatin
Research

Stanford-Led Genome Medicine Study: PAM Enzyme Variants in ~10% of People May Blunt GLP-1 Glycemic Response

A Stanford-led study published March 29 in Genome Medicine, with broad media coverage in late April, identifies two genetic variants that handicap the PAM enzyme (peptidyl-glycine alpha-amidating monooxygenase) responsible for activating GLP-1 and other peptide hormones. In a meta-analysis of three trials with 1,119 participants, carriers — roughly 10% of the general population — were less responsive to GLP-1 drugs and saw smaller HbA1c reductions despite higher circulating GLP-1 levels. The work is the first in-depth investigation of a 'GLP-1 resistance' phenotype, sits alongside the recent 23andMe GLP1R/GIPR variant paper, and opens a path toward genetically-stratified incretin prescribing.

#stanford #pam-enzyme #glp-1-resistance #pharmacogenomics #genome-medicine #hba1c
Industry

Hello Peptide Launches Consumer Education Platform as Post-Category-2 Peptide Curiosity Surges

Hello Peptide announced an expansion of its digital platform HelloPeptide.net on April 30, positioning it as a research-aligned consumer education resource for adults navigating GLP-1 and peptide-therapy decisions. The launch is timed to a documented surge in consumer search and telehealth inquiries that followed the FDA's April 22 Category 2 removal of 12 peptides and the upcoming July 23–24 PCAC meeting. The platform sits alongside FormBlends' 2026 State of Peptides report and a wave of legacy-media safety primers as the post-restriction information ecosystem takes shape.

#hello-peptide #consumer-education #telehealth #category-2 #pcac #peptide-policy