Peptide News Digest

FDA Adds Vision-Loss Warning to All GLP-1 Drugs, Foundayo Eases Sleep Apnea, argenx Buys Peptide Maker UNP

FDA requires a NAION vision-loss warning on every GLP-1 drug, Lilly's Foundayo cuts sleep apnea severity, and argenx pays up to $1.15B for a peptide engine.

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

Editor's Note

The FDA's new NAION warning rests on small absolute numbers: in its pooled analysis of 126 trials, 10 GLP-1 users and 5 placebo patients had probable events, and its Sentinel comparison was significant against DPP-4 inhibitors but not SGLT2 inhibitors. That is why the agency calls the risk potential and tells patients to report sudden, painless vision loss in one eye rather than to stop treatment. The rest of the day's GLP-1 news came from the American Heart Association meeting and pointed the other way: Foundayo cut sleep apnea severity by up to 44% in a 52-week Phase 3 program, and survodutide cleared its cardiovascular safety test, though about one in five people on it stopped because of stomach side effects. A University of Western Australia trial gave practical advice for people already on these drugs: three resistance sessions a week did not change weight loss on tirzepatide but cut lean mass loss and reversed strength loss. Outside obesity, argenx's purchase of Unnatural Products is a bet that ring-shaped peptides can become oral immunology drugs, and three antimicrobial peptide papers range from a lip balm trial in 52 patients to bee venom derivatives designed to slow resistance.

Regulatory

FDA Requires a Warning About NAION, a Rare Cause of Sudden Vision Loss, on Every GLP-1 Drug

The FDA said on November 9 that it is requiring all GLP-1 receptor agonists, including Ozempic, Wegovy, Mounjaro, Zepbound, and Foundayo, to add nonarteritic anterior ischemic optic neuropathy (NAION) to the Warnings and Precautions section of their labels, concluding there is a "potential increased risk of rare NAION events." In a pooled analysis of 126 randomized trials with 134,253 patients, probable NAION occurred at 6.4 events per 100,000 person-years on GLP-1 drugs vs. 3.8 on placebo or other glucose-lowering drugs (10 events vs. 5, all 5 on placebo), and an FDA Sentinel study in type 2 diabetes found a hazard ratio of 1.43 vs. DPP-4 inhibitors (95% CI 1.02 to 2.01) but no significant difference vs. SGLT2 inhibitors. The agency tells patients to seek care right away for sudden, painless vision loss in one eye and tells clinicians to consider stopping the drug in patients who develop NAION.

#naion #glp-1 #fda #side-effects
Clinical Trials

Lilly's Foundayo Pill Cut Sleep Apnea Severity by Up to 44% Over 52 Weeks in Phase 3 Results Published in JAMA

In adults with overweight or obesity who did not use a positive airway pressure machine, sleep apnea severity fell 43.8% on Lilly's once-daily orforglipron over 52 weeks, and it fell 27.5% in those who did use one; both groups lost about 28 pounds on average, Scientific American reported on November 9. Lilly plans to file with the FDA for moderate to severe obstructive sleep apnea by the end of the year. Daniel Drucker, who was not involved and has consulted for Lilly, said each change to GLP-1 drug structure raises questions about overall and cardiovascular safety.

#foundayo #orforglipron #eli-lilly #sleep-apnea
Clinical Trials

Survodutide Passed Its Cardiovascular Safety Test in 5,530 Adults in SYNCHRONIZE-CVOT, but About 1 in 5 Stopped for GI Side Effects

Boehringer Ingelheim and Zealand Pharma's once-weekly glucagon/GLP-1 dual agonist was noninferior to placebo for five-point major adverse cardiovascular events (hazard ratio 0.89, 95% CI 0.67 to 1.18) in adults with obesity or overweight and cardiovascular disease, chronic kidney disease, or at least two weight-related risk factors, AJMC reported from the American Heart Association meeting; the results were published in The Lancet. Weight fell by up to 13.7% vs. 2.0% on placebo at 72 weeks, and 19.3% on 3.6 mg and 20.8% on 6.0 mg stopped because of gastrointestinal side effects vs. 1.9% on placebo. Boehringer says it is preparing regulatory submissions.

#survodutide #boehringer-ingelheim #zealand-pharma
Research

University of Western Australia Trial: Resistance Training Cut Lean Mass Loss and Reversed Strength Loss on Tirzepatide

In a 40-week randomized trial of 120 adults with overweight or obesity, all taking tirzepatide (most reached 15 mg weekly), those assigned to thrice-weekly resistance exercise lost about the same weight as those who were not (22.3 vs. 22.6 kg) but less lean soft tissue mass (3.57 vs. 4.67 kg, difference 1.09 kg). Strength fell on tirzepatide alone (bench press down 4.09 kg) and rose with training (up 4.68 kg); adherence to the sessions was 91%, the Nature Medicine paper reports.

#tirzepatide #resistance-training #nature-medicine
Industry

argenx Agrees to Buy Unnatural Products for $550 Million Upfront and Up to $1.15 Billion to Add Macrocyclic Peptides

argenx will pay $550 million in cash upfront and up to $595 million in development and regulatory milestones for Santa Cruz, California-based Unnatural Products, whose discovery engine designs macrocyclic peptides, small ring-shaped chains of amino acids that can be built to bind disease targets. argenx said in its November 9 announcement that the peptides could support oral or long-acting medicines for immune-mediated diseases alongside its antibody work; the deal is expected to close by the end of 2026.

#macrocyclic-peptides #oral-peptides #acquisitions
Industry

Hims & Hers Swings to a $33 Million Third-Quarter Loss as Gross Margin Falls to 57% After Its Shift to Branded Weight-Loss Drugs

Hims & Hers reported third-quarter revenue of $890.4 million, up 49%, with 2.79 million subscribers, up 13%, but a net loss of $33.0 million compared with net income of $15.8 million a year earlier, as gross margin fell from 74% to 57%. The company narrowed its 2026 revenue forecast to $3.13 billion to $3.15 billion and lowered its adjusted EBITDA range; it said its U.S. weight-loss business has shifted toward branded GLP-1 access, with compounded GLP-1s offered on a limited scale.

#hims-hers #telehealth #earnings
Clinical Trials

UV1 Peptide Vaccine With Olaparib and Durvalumab Missed Its Main Goal in Recurrent Ovarian Cancer in the DOVACC Trial

In the randomized Phase 2 DOVACC trial (NCT04742075) of 188 patients with BRCA wild-type recurrent ovarian cancer, adding UV1, a vaccine of three synthetic long peptides from the telomerase protein hTERT, to olaparib and durvalumab gave a median progression-free survival of 8.7 months vs. 5.9 months on olaparib alone (hazard ratio 0.83, 95% CI 0.68 to 1.01, P = .066), short of statistical significance. OncLive reported on November 9 on the results, presented at the ESMO Congress in October, including exploratory subgroups such as HRD-negative patients (HR 0.73) that would need confirmation.

#peptide-vaccine #cancer-vaccine #ovarian-cancer #ultimovacs
Research

Hebrew University Team Finds a Shortened Bee Venom Peptide, Mel(5-24), Kills Staph With Far Less Resistance Than Melittin

Researchers at the Hebrew University of Jerusalem designed melittin derivatives and ran experimental evolution tests in Staphylococcus aureus: full-length melittin and highly hydrophobic variants drew high resistance, while the truncated Mel(5-24) kept its antibacterial activity with minimal resistance and less cross-resistance to other peptides. Melittin-evolved bacteria shared mutations in pmtR, while Mel(5-24)-evolved bacteria changed only ydbT, and resistance tracked with peptide hydrophobicity and length, the Antimicrobial Agents and Chemotherapy paper reports. The work was done in lab cultures.

#antimicrobial-peptides #antibiotic-resistance #venom-peptides #melittin
Clinical Trials

Chongqing Trial of 52 Patients: Antimicrobial Peptide Lip Balm Matched Tacrolimus for Chronic Cheilitis by Week 4 With Fewer Side Effects

In a double-blind controlled trial at the First Affiliated Hospital of Chongqing Medical University, 52 patients with chronic lip inflammation used a lip balm containing calcium-based antimicrobial peptide compounds or 0.03% tacrolimus ointment for four weeks. Both groups improved markedly by week 4, though tacrolimus worked faster at week 2; mild adverse events occurred in 7.7% vs. 23.1%, and 45 patients completed treatment, the Journal of Cosmetic Dermatology paper reports.

#antimicrobial-peptides #cosmetic-peptide #cheilitis
Research

Konkuk University's Tuberculosis-Enzyme-Inspired Peptide YK-mAK-17 Improved Survival in Mice With CRAB and MRSA Septic Shock

Konkuk University researchers modeled antimicrobial peptides on a Mycobacterium tuberculosis enzyme, adenylate kinase, that recognizes both Gram-negative and Gram-positive cell-wall molecules, then added non-natural amino acids, an N-terminal fatty acid chain, and an arginine extension. The lead peptide, YK-mAK-17, killed carbapenem-resistant Acinetobacter baumannii and MRSA quickly by disrupting their membranes, showed little resistance development, and improved survival and reduced organ damage in mice with septic shock caused by either bacterium, the Journal of Medicinal Chemistry paper reports.

#antimicrobial-peptides #mrsa #sepsis

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