Peptide News Digest

Trump Scraps Medicare BALANCE, BPC-157 Exits FDA Category 2, Avacta PDC Debuts, Evaxion 75% ORR in Melanoma

Trump cancels Medicare GLP-1 pilot after CVS pullout, BPC-157/TB-500 formally exit FDA Cat 2, Avacta PDC shows 3x Enhertu selectivity, 12M lost Wegovy coverage.

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

Editor's Note

Wednesday was a watershed day for US GLP-1 policy: the Trump administration scrapped the five-year Medicare BALANCE pilot after CVS projected $1.4B in 10-year costs, sending Lilly down 2% and Novo down 4%, while NPR reported 12M Americans each lost Wegovy and Zepbound coverage between 2025 and 2026. On the peptide science side, April 22 formally marked BPC-157, TB-500, Semax, Epitalon, and MOTS-c exiting the FDA's Category 2 list ahead of the July PCAC meeting. AACR's final days delivered distinctive peptide-drug-conjugate data — Avacta's AVA6103 showed 3x higher tumor selectivity than Enhertu in preclinical models, and Evaxion's EVX-01 personalized peptide vaccine achieved 75% ORR at 2 years in melanoma with Keytruda. AAN 2026 wrapped with a 22,000-patient migraine study showing GLP-1 agonists cut ED visits 10% and hospitalizations 14% vs topiramate. The week's takeaway: GLP-1 commercialization is consolidating around price-sensitive retail channels (Amazon One Medical launched Monday; Hims dropped 6%) while the broader peptide field advances on both regulatory and clinical fronts.

Trump Administration Scraps Medicare BALANCE GLP-1 Pilot After CVS Pulls Out

The Trump administration on April 22 cancelled the five-year BALANCE Medicare model that would have had private insurers pay for Wegovy and Zepbound as a regular benefit, after CVS opted out citing a projected $1.4 billion cost over 10 years. Medicare will instead cover the drugs directly through the Medicare GLP-1 Bridge from July 1, 2026 through December 31, 2027, with beneficiaries paying $50/month copays.

BPC-157, TB-500, and 10 Other Peptides Formally Exit FDA Category 2 Restricted List

Effective April 22, BPC-157, TB-500, Semax, Epitalon, MOTS-c and seven other peptides were formally removed from the FDA's 503A Category 2 significant-safety-concerns list after original nominators withdrew submissions. The FDA Pharmacy Compounding Advisory Committee will meet July 23-24 to decide whether to add these peptides to the 503A bulks list, which would restore legal compounding under prescription.

NPR Analysis: 12 Million Americans Each Lost Wegovy and Zepbound Coverage in 2026

An April 22 NPR report citing GoodRx research found that 12 million people each lost insurance coverage for Wegovy and Zepbound between 2025 and 2026, while 88% of those still covered face restrictions like prior authorization or BMI 40+ requirements. About 60% of GLP-1 users now pay out of pocket — often hundreds of dollars monthly — reframing the affordability debate after the BALANCE model's cancellation.

Avacta AVA6103 Peptide-Drug Conjugate Shows 3x Tumor Selectivity vs Enhertu in Preclinical Data

Avacta Therapeutics presented April 21 data at AACR 2026 showing its FAP-enabled peptide-drug conjugate AVA6103, which delivers exatecan via the pre|CISION® platform, achieved a Tumor Selectivity Index three times higher than marketed ADC Enhertu in preclinical models, with tumor Cmax more than one log higher. AVA6103 entered the Phase 1 FOCUS-01 trial (NCT07454642) in March 2026 with initial clinical readout expected later this year.

Evaxion EVX-01 Personalized Peptide Vaccine Achieves 75% ORR at 2 Years in Metastatic Melanoma

Evaxion's AI-designed personalized neoantigen peptide vaccine EVX-01 combined with Keytruda produced a 75% objective response rate at 2 years in advanced melanoma patients, with 86% of vaccine targets triggering de novo T-cell responses. Data were presented April 22 at AACR 2026; 3-year follow-up expected in H2 2026. The 86% target-hit rate demonstrates AI-designed peptide neoantigen selection maturing for cancer vaccines.

AlphaGen's [212Pb]Pb-AG1206 Macrocyclic Peptide Radioligand Targets FAP in Solid Tumors

AlphaGen Therapeutics presented preclinical data at AACR 2026 (April 22) showing its novel macrocyclic peptide-based alpha-emitter radioligand [212Pb]Pb-AG1206 binds fibroblast activation protein with picomolar affinity, achieving rapid tumor accumulation, renal clearance, and a high tumor-to-kidney ratio. A sister candidate [212Pb]Pb-AG1002 targets SSTR2 as a non-agonist alpha therapy for neuroendocrine tumors.

AAN 2026: GLP-1 Agonists Cut Migraine ED Visits 10%, Hospitalizations 14% vs Topiramate in 22,000-Patient Study

A presentation at the American Academy of Neurology 2026 meeting (closing April 22) reported that in 10,997 chronic migraine patients initiating GLP-1 agonists versus an equal topiramate cohort, GLP-1 users were 10% less likely to visit the ED (23.7% vs 26.4%), 14% less likely to be hospitalized, 42% less likely to start CGRP monoclonal antibodies, and 48% less likely to start valproate over 12 months — adding migraine to the growing list of GLP-1 secondary benefits.

Foundayo Launch Tracker: 1,390 US Prescriptions in First Full Week, ~45% of Wegovy Pill's Launch Pace

IQVIA tracking data reported April 21 showed Eli Lilly's newly-launched oral GLP-1 Foundayo (orforglipron) drew 1,390 prescriptions in its first full week (April 6-10), roughly 45% of the 3,071 Wegovy pill scripts in Novo Nordisk's launch week in January. Analyst consensus requires Foundayo to hit about 5.4 million prescriptions from April-December to generate $1.7 billion in 2026 revenue — a target that looks challenging at the current trajectory.

Eli Lilly and Novo Nordisk Stocks Slide on Medicare GLP-1 Pilot Cancellation

Eli Lilly shares closed down nearly 2% at $918.56 and Novo Nordisk fell ~4% on April 22 after CVS Health's decision to opt out of the Medicare obesity drug coverage pilot triggered CMS to scrap the BALANCE model. The combined market cap loss across the two GLP-1 leaders exceeded $25 billion. Hims & Hers dropped another 6% on continued Amazon One Medical competitive pressure.

Hims & Hers Drops 6% as Amazon One Medical GLP-1 Program Competitive Pressure Intensifies

Telehealth rival Hims & Hers Health shares slid 6% April 21-22 after Amazon's One Medical launched a comprehensive GLP-1 weight management program offering Wegovy and Foundayo starting at $25/month with insurance or $149/month cash-pay for oral options. The move positions Amazon against established telehealth obesity care providers (Hims, Ro, LifeMD, Noom) as the compounded-GLP-1 era winds down.