Peptide News Digest

Foundayo Liver FAERS Report, Lilly Safety Data Response, RBC Class Defense, Biomea Icovamenib T1D 52-Wk, Immutep ASCO, CordenPharma Boulder $500M

Foundayo single liver FAERS case rocks LLY before Lilly + RBC defend, Biomea T1D C-peptide data, Immutep eftilagimod to ASCO, CordenPharma Boulder $500M.

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

Editor's Note

May 4 was Foundayo day for a different reason than expected. An FDA Adverse Event Reporting System case logged April 30 surfaced publicly, documenting hepatic failure in a 56-year-old male on Foundayo. LLY shares fell 3% premarket before recovering after Eli Lilly's Global Patient Safety team called the event 'not reasonably related to Foundayo' and provided updated safety data the FDA had requested — pointing to no signals of drug-induced liver injury across the 11,000-patient ACHIEVE+ATTAIN program. RBC Capital reiterated its rating with the line 'baseline noise, not a mechanistic safety signal,' noting other GLP-1s have shown comparable case rates (Mounjaro 30, Ozempic 33, Wegovy 15, Zepbound 2). Beyond the GLP-1 fight, Biomea Fusion's icovamenib COVALENT-112 52-week type-1 diabetes data showed a 52% C-peptide increase after only 12 weeks of dosing; Immutep's eftilagimod alfa MHC class II activator earned an ASCO 2026 acceptance; Bicycle Therapeutics dosed the first patient in a Phase 2 nuzefatide pevedotin trial in pancreatic cancer; CordenPharma confirmed its $500M Boulder SPPS expansion will more than double capacity to 42,000 L by 2028; Pfizer is sending 40+ oncology abstracts to ASCO 2026; a 21-expert global panel plans to propose a 10-year GLP-1 cancer-prevention trial at ECO 2026 in Istanbul; and a Frontiers in Medicine review consolidates the antimicrobial-peptide-as-cancer-therapeutic literature for a clinical audience.

Regulatory

Foundayo Liver Failure FAERS Report Surfaces; Lilly Stock Falls 3% Premarket Before Recovering

An FDA Adverse Event Reporting System (FAERS) entry logged April 30 surfaced publicly May 4, documenting hepatic failure in a 56-year-old male patient on Foundayo (orforglipron). The case was marked for expedited review and could have occurred at or before April 15 — Foundayo only launched April 9. There have been 34 total Foundayo FAERS reports so far, with two considered serious. LLY traded down nearly 3% premarket — hitting roughly $936 — before recovering on Lilly's response. Foundayo's label carries a warning that the medication is 'not recommended for use in patients with severe hepatic impairment' (orforglipron is primarily hepatically metabolized), but mild and moderate liver impairment is allowed at standard dose.

#foundayo #orforglipron #eli-lilly #fda #faers #liver-safety #drug-induced-liver-injury
Industry

Eli Lilly Releases Updated Foundayo Safety Data Following FDA Request, Cites 11,000-Patient Program with No DILI Signal

Eli Lilly's Global Patient Safety team responded to the FDA's request for updated Foundayo safety information on May 4, concluding the FAERS event was 'not reasonably related to Foundayo.' The company pointed to the 11,000-participant ACHIEVE and ATTAIN program — followed for up to two years — where the liver safety profile of Foundayo was similar to placebo and active comparator medicines, with no cases of drug-induced liver injury observed and no hepatic safety signal detected. ACHIEVE-4 specifically included a thorough drug-induced liver injury (DILI) analysis with no hepatic signals, consistent with the 57% lower all-cause death rate (HR 0.43) seen versus insulin glargine in that arm.

#eli-lilly #foundayo #achieve-4 #drug-induced-liver-injury #patient-safety #fda-request
Industry

RBC Capital Defends LLY: Foundayo Single Liver Case is 'Baseline Noise, Not a Mechanistic Safety Signal'

RBC Capital reiterated its Outperform rating on Eli Lilly May 4 with the framing 'baseline noise, not a mechanistic safety signal,' and put the single Foundayo case in context against the broader GLP-1 class hepatic failure tally: Mounjaro 30 cases, Zepbound 2, Ozempic 33, Wegovy 15. Other Street analysts followed similar reasoning. The defense rests on the 11,000-patient clinical program and the absence of any DILI signal across two years of follow-up. The framing matters because the launch trajectory for Foundayo had already been challenged by IQVIA tracker data showing the Wegovy pill running roughly 20× ahead in retail prescriptions; a sustained safety overhang would compound the commercial pressure.

#eli-lilly #lly-stock #rbc-capital #foundayo #liver-safety #analyst-defense #glp-1-class
Clinical Trials

Biomea Fusion Icovamenib Phase 2 COVALENT-112 (April 27): 52% C-Peptide AUC Increase at Week 12 in Recently-Diagnosed Type 1 Diabetes, Sustained Through Week 52

Biomea Fusion announced April 27 positive 52-week Phase 2 COVALENT-112 results in newly diagnosed type 1 diabetes. Patients diagnosed within 0–3 years dosed with icovamenib 200 mg once daily for 12 weeks showed a 52% increase in mean C-peptide AUC at Week 12 (p<0.001, n=5), with persistence through Week 52 (only ~7% decline from baseline) following just 12 weeks of dosing. C-peptide preservation was also observed in patients diagnosed 3–15 years prior (n=9). Icovamenib, a covalent menin inhibitor, was generally well tolerated with no new safety signals. Biomea is planning a Phase 2 expansion at four US academic centers in H2 2026 evaluating extended dosing (6 or 12 months) at 200 mg, with potential addition of an immunosuppressive agent. The data shifts attention back to beta-cell preservation as a T1D therapeutic strategy.

#biomea-fusion #icovamenib #covalent-112 #c-peptide #type-1-diabetes #menin-inhibitor #beta-cell
Clinical Trials

Immutep Eftilagimod Alfa MHC Class II Activator Heading to ASCO 2026 with Lymphocyte Activation + Survival Outcomes Data in Metastatic Cancer

Immutep announced April 22 that an abstract for its lead asset eftilagimod alfa — a soluble LAG-3 protein that activates antigen-presenting cells via MHC class II — has been accepted for poster presentation at ASCO 2026 (May 29–June 2, Chicago). The abstract, titled 'Impact of eftilagimod alfa, an APC activator via MHC class II, on lymphocyte activation and survival outcomes in metastatic cancer patients,' adds a non-checkpoint immunotherapy modality to the ASCO 2026 peptide-and-immuno slate alongside Bicycle Therapeutics' Duravelo-2, BriaCell's Bria-IMT, BioVaxys's MVP-S, and Greenwich LifeSciences' GP2 program.

#immutep #eftilagimod-alfa #lag-3 #asco-2026 #mhc-class-ii #cancer-immunotherapy
Industry

CordenPharma Confirms $500M Boulder SPPS Expansion to More Than 42,000 L Capacity by 2028, Adding 200+ Jobs and 64,000 sq ft Lab Space

CordenPharma's Boulder, Colorado expansion is now confirmed at $500 million, with the first phase coming online in 2026 and full completion in 2028. The site will add new large-scale manufacturing lines and a greenfield facility that more than doubles its solid-phase peptide synthesis (SPPS) capacity to over 42,000 liters by 2028 — positioning Boulder among the largest peptide production sites worldwide. CordenPharma Colorado leased 64,000 square feet at BioMed Realty's Flatiron Park 5505 Central — Boulder's first purpose-built speculative lab building — and will add more than 200 employees to the existing 700-person workforce. The expansion sits within CordenPharma's broader €900M+ ($1B+) global peptide platform investment that also includes a >€500M greenfield site near Basel.

#cordenpharma #peptide-cdmo #boulder #spps #manufacturing-capacity #biomed-realty
Clinical Trials

Bicycle Therapeutics Doses First Patient in Phase 2 Nuzefatide Pevedotin Trial in Recurrent Pancreatic Cancer (April 2026)

Bicycle Therapeutics confirmed in its AACR 2026 update that the company began enrolling patients in a Phase 2 study of nuzefatide pevedotin (BT5528) in adults with recurrent pancreatic ductal adenocarcinoma in March 2026, with the first patient successfully dosed in April. The bicyclic peptide-drug conjugate targets EphA2-expressing tumor cells. Earlier Phase 1/2 data — through a February 9, 2026 cutoff — showed 40% confirmed ORR in EphA2+ urothelial cancer patients on nuzefatide 6.5 mg/m² plus nivolumab, rising to 100% confirmed ORR in MMAE-naïve EphA2+ patients (n=14). The company has identified 8 mg/m² Q2W as the preferred monotherapy dose. The PDAC trial extends Bicycle's footprint into a difficult tumor type where EphA2 imaging readouts at AACR 2026 reinforced target validation.

#bicycle-therapeutics #nuzefatide-pevedotin #bt5528 #epha2 #pancreatic-cancer #bicyclic-peptide #phase-2
Industry

Pfizer to Present 40+ Oncology Abstracts at ASCO 2026 Including Peptide-Drug Conjugate and Bispecific Programs

Pfizer announced that data from more than 40 company-sponsored, investigator-sponsored, and collaborative research abstracts will appear at ASCO 2026 in Chicago (May 29–June 2). The slate spans Pfizer's diverse oncology pipeline including peptide-drug conjugate programs, bispecific T-cell engagers, and antibody-drug conjugates. Combined with previously announced ASCO 2026 acceptances from Bicycle Therapeutics, BriaCell, Greenwich LifeSciences, BioVaxys, and Immutep, the meeting is shaping up as the most peptide-and-immuno-conjugate-heavy ASCO in recent memory — building on the foundation laid at AACR 2026 in San Diego.

#pfizer #asco-2026 #peptide-drug-conjugate #oncology #antibody-drug-conjugate #bispecific
Research

ECO 2026 Curtain-Raiser: 21-Expert Global Panel to Propose 10-Year GLP-1 Cancer Prevention Trial at Istanbul Congress (May 12–15)

Ahead of the European Congress on Obesity in Istanbul (May 12–15), a 21-expert global panel of obesity and cancer specialists will present a research proposal for a 10-year prospective trial testing GLP-1 receptor agonists like semaglutide and tirzepatide for prevention of obesity-related cancers. The proposal builds on the SELECT trial's established cardiovascular benefit, real-world dementia-incidence reductions, and the broader case that GLP-1s influence multiple aging-driven disease categories. The Istanbul meeting is the same venue where Novo Nordisk will present 52 abstracts on Wegovy, the higher-dose 7.2 mg formulation, the Wegovy pill, and CagriSema, including data on women's obesity, perimenopause, and migraine.

#eco-2026 #glp-1 #cancer-prevention #obesity #istanbul #expert-panel
Research

Frontiers in Medicine 2026 Review: Antimicrobial Peptides Pull Double Duty as Anticancer Agents and Vaccine Adjuvants

A Frontiers in Medicine review published in 2026 consolidates the case for antimicrobial peptides (AMPs) as anticancer therapeutics and vaccine adjuvants. The cationic, amphipathic architecture that makes AMPs effective against bacterial membranes also enables selective electrostatic interactions with negatively charged malignant cell membranes — driving rapid membrane disruption and cell lysis. Beyond direct membrane effects, the review documents AMP-induced inhibition of DNA replication and protein synthesis, mitochondrial dysfunction, and tumor angiogenesis suppression. The piece also catalogs AMPs with adjuvant properties that boost vaccine immune responses against cancer and infectious disease. The work joins the Houston Methodist CAMPER MRSA paper, the Nature Communications few-shot Acinetobacter pipeline, and the Manchester penicillin-biosynthesis paper as part of the AMP wave through April–May 2026.

#antimicrobial-peptides #anticancer-peptides #frontiers-medicine #vaccine-adjuvants #amr