May 2, 2026

Lilly Retatrutide TRANSCEND T2D1 Phase 3, Amgen MariTide Q1 Pipeline, Mount Sinai mRNA Liver-Detargeting, BioVaxys MVP-S ASCO 2026, Foundayo PBM Access

Lilly retatrutide TRANSCEND T2D1 reads out, Amgen MariTide Phase 3 detail at Q1, Mount Sinai liver-detargeted mRNA cancer vaccines, BioVaxys MVP-S to ASCO 2026.

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

Editor's Note

Two non-headline angles from the April 30 earnings cycle drove peptide-relevant news through May 2. Lilly's Q1 call disclosed positive topline results from TRANSCEND T2D1, the first Phase 3 trial of the triple GLP-1/GIP/glucagon agonist retatrutide in type 2 diabetes — A1c down 1.7 to 2.0 percentage points and 25 to 37 lb mean weight loss versus placebo, with seven additional Phase 3 readouts still to come this year. Amgen's same-day print confirmed MariTide MARITIME-1 is enrolling in obesity, MARITIME-2 EXTENSION has launched for weight-loss maintenance, and three Phase 3 type 2 diabetes studies are slated to start in 2026 — keeping the peptide-conjugate monthly-dosing thesis alive against the once-weekly Mounjaro/Zepbound machine. The Foundayo launch sub-narrative also clarified: 20,000 patients are now on the drug, more than 8,000 prescribers have written it (one-third are first-time oral GLP-1 prescribers), and commercial access is confirmed at two of the three largest U.S. PBMs effective mid-May. Beyond GLP-1s, a Mount Sinai paper in Nature Biotechnology overturned a longstanding mRNA-vaccine assumption by showing hepatocyte detargeting more than doubles cancer-vaccine efficacy in lymphoma models, BioVaxys' MVP-S survivin peptide-vaccine PESCO trial earned an ASCO 2026 acceptance in recurrent ovarian cancer, and Aivocode's CAQK tetrapeptide for traumatic brain injury — published in EMBO Molecular Medicine — moved closer to a planned U.S. IND. On the regulatory side, the Partnership for Safe Medicines threw its weight behind the FDA's April 30 503B-bulks-list proposal, and Orrick's May client memo translated what the rule shift means for outsourcing facilities, telehealth platforms, and weight-loss clinics still leaning on compounded GLP-1 supply.

Clinical Trials

Lilly Q1 Earnings Call (April 30): Retatrutide TRANSCEND T2D1 First Phase 3 in Type 2 Diabetes — A1c Down 1.7–2.0 Pts, 25–37 lb Mean Weight Loss

On the April 30 Q1 2026 call, Eli Lilly disclosed positive topline results from TRANSCEND T2D1, the first Phase 3 trial of retatrutide (triple GLP-1/GIP/glucagon agonist) in adults with type 2 diabetes. Compared with placebo, retatrutide lowered A1c by an average of 1.7 to 2.0 percentage points across doses and produced mean weight loss of 11.1 to 16.6 kilograms (25 to 37 pounds). The data complement the previously reported TRIUMPH-4 obesity-with-knee-osteoarthritis results (28.7% weight loss, 75.8% pain reduction). TRIUMPH-1, an 80-week obesity study, is the next retatrutide readout expected, with seven additional Phase 3 readouts still to come in 2026 ahead of a planned regulatory submission late 2026 or 2027.

#retatrutide #transcend-t2d1 #eli-lilly #triple-agonist #type-2-diabetes #phase-3 #triumph

Industry

Amgen Q1 2026 (April 30): MariTide MARITIME-1 Phase 3 Ongoing, MARITIME-2 EXTENSION Initiated, Three T2D Phase 3 Studies Slated for 2026

Amgen reported Q1 2026 revenue of $8.6 billion (+6%) on April 30 alongside an obesity-pipeline update. MariTide — a peptide-antibody conjugate that activates the GLP-1 receptor and antagonizes the GIP receptor with monthly or less frequent dosing — has the Phase 3 MARITIME-1 study ongoing in adults with obesity or overweight, and Amgen has now launched the MARITIME-2 EXTENSION study to evaluate weight-loss maintenance. Three Phase 3 studies of MariTide in people with type 2 diabetes are planned to start in 2026, alongside a Phase 2b liver-fat-reduction study and the Phase 1 study of follow-on candidate AMG 513 in obesity.

#amgen #maritide #maritime-1 #maritime-2 #amg-513 #monthly-glp-1 #peptide-antibody-conjugate

Research

Mount Sinai Nature Biotechnology (April 29): Liver-Detargeted mRNA Vaccines Boost Cancer Immunity, Cut Lymphoma Tumor Burden by Over 50% in Mouse Models

An Icahn School of Medicine at Mount Sinai team reported in Nature Biotechnology on April 29 that hepatocytes actively dampen the immune response to standard mRNA vaccines and that engineering vaccines to avoid hepatocyte expression sharply boosts efficacy. In mice with lymphoma, an mRNA vaccine engineered to silence hepatocyte expression cut tumor burden by more than 50% versus a conventional mRNA vaccine, driven by a stronger killer T-cell response. The finding inverts a longstanding assumption that liver expression is helpful and supplies a generalizable design principle for mRNA cancer vaccines, infectious-disease vaccines, and gene-editing payloads.

#mount-sinai #mrna-vaccine #hepatocyte-detargeting #lymphoma #nature-biotechnology #cancer-immunotherapy

Clinical Trials

BioVaxys MVP-S Survivin Peptide Vaccine PESCO Phase 1B/2 Trial Accepted at ASCO 2026 in Recurrent Ovarian Cancer

BioVaxys announced April 27 that the abstract from the investigator-initiated PESCO trial — an open-label, non-randomized Phase 1B/2 study evaluating the company's MVP-S (maveropepimut-S) DPX-formulated peptide vaccine in combination with pembrolizumab and cyclophosphamide in recurrent epithelial ovarian cancer — has been accepted for presentation at the 2026 ASCO Annual Meeting in Chicago (May 29–June 6). MVP-S is a five-peptide survivin-targeted formulation that pairs the peptides with a T-helper sequence and an innate-immune stimulant; the program tests whether the cytotoxic T-cell response can be combined effectively with checkpoint blockade in platinum-resistant disease.

#biovaxys #mvp-s #maveropepimut-s #survivin #ovarian-cancer #asco-2026 #peptide-vaccine

Industry

Partnership for Safe Medicines Applauds FDA's 503B GLP-1 Bulks-List Proposal, Plans Federal Register Comment

The Partnership for Safe Medicines issued a May statement strongly supporting the FDA's April 30 proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B outsourcing-facility bulks list, citing 'sound science, sound law, and a clear-eyed commitment to patient safety.' The Partnership cited more than 455 adverse-event reports linked to compounded semaglutide and more than 320 tied to compounded tirzepatide — many involving dosing errors from multidose vials, some leading to hospitalization — as the safety basis. The group plans to submit a full comment to the Federal Register docket before the June 29 deadline and is encouraging other patient-safety groups to do the same.

#partnership-for-safe-medicines #fda #503b #compounding #glp-1 #patient-safety

Regulatory

Orrick Client Memo: 'FDA Moves to Shut the Door on Large-Scale Compounding of GLP-1 Drugs' Translates the 503B Proposal for Outsourcing Facilities and Telehealth

Orrick published a May 2026 client memo walking through the FDA's April 30 proposal to formally exclude semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro, Zepbound), and liraglutide (Victoza, Saxenda) from the 503B outsourcing-facility bulk drug substances list. The memo flags that the FDA declared the tirzepatide shortage resolved in October 2024 and the semaglutide shortage resolved in February 2025, removing the two legal pathways that previously enabled large-scale compounding. Orrick advises weight-loss clinics, medical spas, and telehealth platforms still relying on compounded GLP-1 products to consult counsel ahead of the June 29 comment deadline.

#orrick #fda #503b #compounding #glp-1 #telehealth #legal-memo

Industry

Lilly Q1 Earnings Call: Foundayo Reaches 20K Patients, 8K+ Prescribers (33% First-Time Oral GLP-1), Mid-May Major PBM Access

On the April 30 call, Lilly USA executive Ilya Yuffa said roughly 20,000 patients are now on Foundayo (orforglipron) for obesity or overweight and more than 8,000 prescribers have written it. Notably, 80% of patients are new to the GLP-1 class and one-third of prescribers had not previously written an oral GLP-1, suggesting Foundayo is expanding the addressable market rather than purely cannibalizing injectables. Lilly also confirmed commercial access at two of the three largest U.S. pharmacy benefit managers effective mid-May. Active sales-force promotion only began the week of April 23, two weeks after broad supply-channel availability on April 9.

#foundayo #orforglipron #eli-lilly #pbm-access #prescriber-data #oral-glp-1

Industry

Hims & Hers Stock Up 9% Heading into May 11 Q1 Print as Investors Bet on Peptide Pipeline + Novo Nordisk Partnership

Hims & Hers shares climbed roughly 9% in early-week trading from $28.82 to $31 ahead of the company's May 11 Q1 2026 earnings, extending a five-session run that has lifted the stock about 49%. The catalysts: renewed FDA interest in peptides via the upcoming July PCAC meeting and the company's Novo Nordisk collaboration providing branded Wegovy and Ozempic access. Hims also flagged a 2026 longevity specialty launch covering peptides, coenzymes, and GLP/GIP treatments, and continues to invest in the California peptide-manufacturing facility acquired in February 2025 — which could pivot to producing reclassified Category 1 peptides if the July PCAC clears the path.

#hims-hers #novo-nordisk #peptide-pipeline #telehealth #longevity #pcac

Clinical Trials

Boehringer Survodutide LIVERAGE / LIVERAGE-Cirrhosis Phase 3 MASH Programs Underway, Building on Phase 2 83% Histological Improvement

Following the April 28 SYNCHRONIZE-1 obesity topline (16.6% weight loss at 76 weeks), Boehringer Ingelheim and Zealand Pharma confirmed that survodutide — their dual GLP-1/glucagon agonist — has two global Phase 3 MASH trials underway: LIVERAGE in adults with MASH and fibrosis stages F2 or F3, and LIVERAGE-Cirrhosis in compensated MASH cirrhosis. The Phase 3 program follows Phase 2 data showing 83% of MASH patients achieved histological improvement at 48 weeks. The MASH track positions survodutide alongside tirzepatide's SYNERGY-NASH and broader Lilly Phase 3 activity in the metabolic-liver-disease space, with full SYNCHRONIZE-1 data slated for ADA 2026 in June.

#boehringer #survodutide #zealand-pharma #mash #liverage #phase-3 #glp-1-glucagon

Research

EMBO Molecular Medicine: Aivocode CAQK Tetrapeptide Reduces Brain Lesion Size and Inflammation in Mouse and Pig TBI Models, FDA IND Planned

An IQAC-CSIC, UC Davis, and Aivocode collaboration published in EMBO Molecular Medicine demonstrates that the four-amino-acid peptide CAQK, given intravenously after acute traumatic brain injury, homes specifically to a protein overexpressed in injured brain tissue and reduces lesion size, inflammation, and cell death. In mouse and pig TBI models, CAQK-treated animals showed lower expression of inflammatory markers and improved memory and behavioral test outcomes versus untreated controls, with no overt toxicity. Aivocode — a Sanford Burnham Prebys spin-out — has signaled it will seek FDA authorization to begin Phase 1 human trials. The work targets a market with no approved drug for stopping secondary TBI damage; Spain alone records about 100,000 TBIs annually.

#caqk #aivocode #traumatic-brain-injury #tetrapeptide #embo-molecular-medicine #iqac-csic #neuroprotection