Peptide News Digest

J&J Icotrokinra Oral IL-23R Peptide EU Approval, Celldex Barzolvolimab Phase 3 CSU Win, Viking VK2735 Maintenance Data

J&J's oral IL-23R peptide icotrokinra wins EU approval, barzolvolimab hits both Phase 3 CSU trials, and VK2735 keeps up to 97% of weight loss on maintenance.

6 stories · Covering regulatory, clinical-trials, industry

Editor's Note

The European Commission approved Johnson & Johnson's ICOTYDE (icotrokinra), which J&J describes as the first targeted oral peptide that blocks the IL-23 receptor, for adults and adolescents with moderate-to-severe plaque psoriasis; the peptide was discovered with Protagonist Therapeutics. Celldex reported that barzolvolimab, an anti-KIT antibody, met the primary endpoint in both Phase 3 EMBARQ trials in chronic spontaneous urticaria, with complete response rates of 42-46% at week 12 against 9-13% on placebo. Viking's VK2735 maintenance study tested whether people can step down from weekly dosing: after 21 weeks of weekly induction, every-other-week dosing kept up to 97% of the weight lost and monthly dosing up to 90%, against 61% on placebo. NewAmsterdam Pharma and Menarini received the first approval anywhere for obicetrapib, and PTC Therapeutics closed its purchase of Sangamo's Fabry gene therapy ST-920. Novo's shares fell about 8% on Monday after its Capital Markets Day, and BMO's Evan Seigerman wrote that the peer-level growth target looked already priced in. Correction (September 23, 2026): This digest was revised to remove claims that could not be traced to a primary source and to replace general source links with specific ones. Removed items include an unsupported year-to-date decline figure for Novo (previously given as close to 25%) and an unsupported additional Tuesday decline, a claim that Morgan Stanley held the most bearish Novo rating, market-size and patient-population estimates, and a statement that competing obesity drugs support only weekly maintenance.

European Commission Approves Johnson & Johnson's ICOTYDE (Icotrokinra), an Oral Peptide IL-23 Receptor Antagonist, for Moderate-to-Severe Plaque Psoriasis in Adults and Adolescents

Johnson & Johnson announced on Monday, September 21, 2026 that the European Commission granted marketing authorization for ICOTYDE (icotrokinra) for adults and adolescents aged 12 and older weighing at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. J&J calls icotrokinra the first targeted oral peptide that precisely blocks the IL-23 receptor; it was jointly discovered and is being developed under J&J's license and collaboration agreement with Protagonist Therapeutics. The approval rests on the ICONIC program of four Phase 3 studies in about 2,500 patients (ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1 and 2). In the head-to-head studies, about 70% of patients on icotrokinra reached clear or almost clear skin (IGA 0/1) and 55% reached PASI 90 at week 16. Patients take one pill once daily with water on waking, at least 30 minutes before eating.

Celldex Therapeutics Barzolvolimab (Anti-KIT Monoclonal Antibody) Meets Primary and All Key Secondary Endpoints in Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Trials in Chronic Spontaneous Urticaria

Celldex Therapeutics reported on Tuesday, September 22, 2026 that both Phase 3 trials of barzolvolimab, a humanized monoclonal antibody that binds the KIT receptor on mast cells, met their primary endpoint of mean change in weekly urticaria activity score (UAS7) at week 12 in adults with chronic spontaneous urticaria who remained symptomatic on H1 antihistamines. EMBARQ-CSU1 randomized 963 patients and EMBARQ-CSU2 randomized 976, for 1,939 in total. UAS7 fell by 19.7 to 20.5 points on the two barzolvolimab regimens (150 mg every 4 weeks or 300 mg every 8 weeks) versus 10.7 and 11.4 points on placebo, and complete response (UAS7 of 0) rates were 42.1% to 45.7% versus 9.3% and 12.6% on placebo. All key secondary endpoints were met, benefit was reported in omalizumab-refractory patients, and the drug was well tolerated through 24 weeks. Treatment continues to 52 weeks, and Celldex plans to file a Biologics License Application in 2027.

Viking Therapeutics VK2735 (GLP-1/GIP Dual Agonist) Maintenance Study: Every-Other-Week Dosing Keeps Up to 97% and Monthly Dosing Up to 90% of Weight Lost During 21-Week Induction

Viking Therapeutics reported on Tuesday, September 22, 2026 topline results from a double-blind, placebo-controlled maintenance study of VK2735, its dual GLP-1/GIP receptor agonist, in about 180 adults with a BMI of 30 or higher. After 21 weeks of weekly dosing, placebo-adjusted weight loss was 16% to 19% across VK2735 cohorts; an exploratory cohort on 17.5 mg weekly (n=13) reached about 22% weight loss from baseline at week 33. In the 12-week randomized maintenance phase, every-other-week dosing kept up to 97% of mean weight loss and monthly dosing up to 90%, compared with 61% for patients switched to placebo. Viking said gastrointestinal adverse event rates during maintenance were similar to placebo, and it plans a second part of the study to test oral maintenance regimens.

NewAmsterdam Pharma and Menarini Receive First Obicetrapib Approval Worldwide: European Commission Approves Ubeslo and Evlarco for Primary Hypercholesterolemia

NewAmsterdam Pharma and Menarini Group announced on Monday, September 21, 2026 that the European Commission approved Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg) for adults with primary hypercholesterolemia, including heterozygous familial and non-familial forms, or mixed dyslipidemia. The companies called it the first regulatory approval of obicetrapib, an oral, low-dose CETP inhibitor, anywhere in the world. The approval cites the Phase 3 BROADWAY, BROOKLYN, and TANDEM trials, which showed LDL-C reductions of up to 40% with obicetrapib alone and about 50% with the ezetimibe combination versus placebo, with tolerability comparable to placebo. Menarini holds exclusive European commercialization rights and pays NewAmsterdam tiered double-digit royalties, with up to €833 million more in milestones.

PTC Therapeutics Completes Acquisition of Sangamo's ST-920 (Isaralgagene Civaparvovec) Fabry Disease Gene Therapy; Rolling BLA to Finish in Q4 2026

PTC Therapeutics said on Monday, September 21, 2026 that it completed its acquisition of ST-920 (isaralgagene civaparvovec) from Sangamo Therapeutics. ST-920 is a one-time AAV gene therapy for Fabry disease that is designed to enable long-term production of the missing alpha-galactosidase A enzyme in place of chronic enzyme replacement therapy. Under terms announced in August, PTC won the asset in Sangamo's Chapter 11 auction for $111 million upfront plus up to $100 million in approval milestones; Eli Lilly separately bought Sangamo's zinc finger programs for $50 million. ST-920 holds FDA Orphan Drug, Fast Track, and RMAT designations and EMA PRIME eligibility, and PTC expects to complete a rolling Biologics License Application for accelerated approval in the fourth quarter of 2026.

Novo Nordisk Shares Fall About 8% After Capital Markets Day; BMO's Evan Seigerman Says Peer-Level Growth Target Looks Already Priced In

Novo Nordisk shares fell about 8% in both Copenhagen and New York on Monday, September 21, 2026, the day of its London Capital Markets Day, according to GEN. BMO Capital Markets analyst Evan Seigerman wrote that Novo is "targeting 2026-2030 revenue growth in line with industry peers, likely underwhelming for investors," and noted that consensus already models about 3.53% annual growth for Novo against roughly 3.65% for pharma peers, so the target appeared priced into Wall Street estimates. The company used the event to set 2030 ambitions that included more than five potential blockbuster launches.