Peptide News Digest

Novo STEP Young Phase 3 Wins in Children Under 12, HERMES + ATHENA Ziltivekimab Trials Halted, Ascendis reACHin Sentinel Data

Novo semaglutide clears STEP Young Phase 3 in children 6-11, ziltivekimab HF trials HERMES + ATHENA halted, Ascendis reACHin sentinel data at ESPE Tuesday.

7 stories · Covering clinical-trials, industry, research

Editor's Note

Monday's news cycle carried a split Novo Nordisk pipeline story that will shape investor and clinical conversations through the coming week. The company's semaglutide franchise added another indication-ready dataset: STEP Young reported that 40.4% of children aged 6 to under 12 with obesity achieved a BMI below the obesity threshold at week 68 versus 0% in the placebo group, with a safety profile matching adult and adolescent trials and no signal on growth or pubertal development. On the same day Novo confirmed it had terminated its ziltivekimab HERMES and ATHENA heart failure trials early after a data monitoring committee ruled the studies unlikely to succeed, following the earlier ZEUS miss reported in August. The two announcements together left Novo shares down about 2% and reinforced the pattern of a strong obesity franchise carrying a narrowing set of non-GLP-1 growth options. Peptide news around the European Respiratory Society Congress in Barcelona (September 5-9) and the European Society for Paediatric Endocrinology meeting in Marseille (September 8-10) crowded the start of the week, with Ascendis Pharma previewing the first navepegritide (TransCon CNP) sentinel-cohort data from the Phase 3 reACHin trial in achondroplasia infants and Roivant's Pulmovant scheduling its Phase 2 PHocus readout for mosliciguat in pulmonary hypertension associated with interstitial lung disease on Tuesday. Vicore Pharma, Insmed, and Trevi Therapeutics each brought respiratory-portfolio abstracts to the Barcelona meeting on Sunday and Monday. Post-Labor-Day weekend news volume was thin; verified stories take priority over quotas here.

Clinical Trials

Novo Nordisk STEP Young Phase 3: 40.4% of Children Aged 6 to Under 12 No Longer Classified as Obese at Week 68 With Semaglutide Plus Lifestyle Modification Versus 0% Placebo

Novo Nordisk (NYSE: NVO) announced Monday September 7, 2026 first results from STEP Young, a Phase 3 randomized double-blind placebo-controlled multinational trial evaluating once-weekly semaglutide combined with a reduced-calorie diet and increased physical activity in children aged 6 to under 12 years with obesity. The trial enrolled 165 children, dosed with a maximum of 1.7 mg or 2.4 mg semaglutide based on baseline weight. At week 68, 40.4% of the semaglutide group had a BMI below the obesity threshold versus 0% in the placebo group; more than 85% of enrolled children had class II or III severe obesity (BMI ≥35 or ≥40 by adult equivalents) at baseline. Safety and tolerability were consistent with adult and adolescent trials with no new safety concerns and no signals related to growth or pubertal development. Detailed results will be presented at ObesityWeek 2026 in Washington DC November 14-17. Wegovy is currently approved in the U.S. for adolescents 12 and older; a supplemental submission for children under 12 has not been announced.

#novo-nordisk #nvo #semaglutide #wegovy #step-young #phase-3 #pediatric-obesity #children-6-to-under-12 #165-children #40-4-percent-below-threshold #week-68 #obesityweek-2026 #class-ii-iii-obesity #no-growth-signal #glp-1
Clinical Trials

Novo Nordisk Terminates Ziltivekimab HERMES and ATHENA Phase 3 Heart Failure Trials Early After DMC Rules Studies Unlikely to Succeed

Novo Nordisk (NYSE: NVO) confirmed Monday September 7, 2026 that it had informed investigators on Friday September 4 that the HERMES and ATHENA Phase 3 trials of ziltivekimab (an anti-IL-6 monoclonal antibody) would end early on the recommendation of an independent data monitoring committee that judged the studies unlikely to succeed. HERMES evaluated ziltivekimab against time to first occurrence of heart failure endpoints including cardiovascular death and heart-failure-linked hospitalisation or urgent visits; ATHENA evaluated the drug's effect on quality of life and other heart-failure-specific measures. The terminations follow the June 2026 ZEUS trial miss (chronic kidney disease plus cardiovascular disease) reported at the ESC Congress August 30, where ziltivekimab lowered inflammation markers but did not reduce major adverse cardiovascular events. A separate post-acute heart failure study of ziltivekimab remains ongoing. Novo shares finished down about 2% on the announcement day (Copenhagen trading open; NYSE closed for Labor Day), with the pediatric semaglutide win offset by the further narrowing of the company's non-GLP-1 growth options.

#novo-nordisk #nvo #ziltivekimab #anti-il-6-monoclonal-antibody #hermes-trial #athena-trial #phase-3-terminated #data-monitoring-committee #heart-failure #zeus-trial-context #non-glp-1-pipeline #non-peptide
Industry

Ascendis Pharma to Present First reACHin Sentinel-Cohort Data for Navepegritide (TransCon CNP) in Achondroplasia Infants at ESPE 2026 Tuesday September 8

Ascendis Pharma A/S (NASDAQ: ASND) announced Monday September 7, 2026 that the first sentinel-cohort data from the Phase 3 reACHin trial of navepegritide (TransCon CNP, a sustained-release CNP peptide prodrug) in infants with achondroplasia aged 0 to under 2 years will be presented as a podium talk at the European Society for Paediatric Endocrinology (ESPE) 2026 congress in Marseille, France (September 8-10). The reACHin presentation (FC4.6) is scheduled for Tuesday September 8, 3:00-4:00 p.m. CEST by Genevieve Baujat MD. Additional presentations include the HighLiGHts Phase 3 trial design for lonapegsomatropin (TransCon hGH) across Turner syndrome, SHOX deficiency, small-for-gestational-age, and idiopathic short stature; hypoparathyroidism patient-reported-outcome data from adolescents; and a systematic literature review on pediatric growth hormone deficiency prevalence. Ascendis submitted the TransCon CNP marketing authorization application to the EMA in October 2025 with an EU decision expected Q4 2026. Navepegritide is engineered to provide continuous CNP receptor stimulation without the peak-and-trough kinetics that constrained earlier vosoritide (Voxzogo) dosing.

#ascendis-pharma #asnd #navepegritide #transcon-cnp #reachin-trial #sentinel-cohort #achondroplasia-infants #espe-2026 #marseille #vosoritide-comparator #voxzogo-comparator #lonapegsomatropin #transcon-hgh #highlights-trial #hypoparathyroidism-pro #peptide-prodrug
Industry

Roivant and Pulmovant Set Tuesday September 8 Phase 2 PHocus Topline Readout for Mosliciguat in Pulmonary Hypertension Associated With Interstitial Lung Disease at ERS Congress 2026

Roivant Sciences (NASDAQ: ROIV) and its Pulmovant subsidiary announced Sunday September 6, 2026 that Phase 2 PHocus topline results for mosliciguat (a once-daily inhaled soluble guanylate cyclase activator) in pulmonary hypertension associated with interstitial lung disease (PH-ILD) will be presented Tuesday September 8, 2026 at 12:15 CEST (6:15 a.m. ET) at the European Respiratory Society Congress 2026 in Barcelona by Marc Humbert MD PhD (Université Paris-Saclay; French National Reference Center for Pulmonary Hypertension). The randomized double-blind placebo-controlled global trial enrolled 135 adults with PH-ILD; the primary endpoint is change from baseline in pulmonary vascular resistance at week 16, with the controlled period running through week 24. Roivant will host an investor call at 8:00 a.m. ET the same day. Mosliciguat is an sGC activator that works independently of heme and nitric oxide, differentiating it from sGC stimulators like riociguat. In the earlier Phase 1b ATMOS study a single inhaled dose produced a mean peak reduction in pulmonary vascular resistance of up to 38%. The PVR change versus placebo is the metric investors are watching; the same endpoint anchored the Phase 3 program for United Therapeutics' Tyvaso (treprostinil) in PH-ILD.

#roivant-sciences #roiv #pulmovant #mosliciguat #phocus-trial #phase-2-topline #ph-ild #pulmonary-hypertension #interstitial-lung-disease #inhaled-sgc-activator #135-patients #pulmonary-vascular-resistance #week-16-primary #atmos-phase-1b #tyvaso-treprostinil-context #ers-congress-2026 #barcelona #non-peptide
Clinical Trials

Vicore Pharma Presents ASPIRE Phase 2b Trial Design for Buloxibutid AT2R Agonist in Idiopathic Pulmonary Fibrosis at ERS Congress Monday September 7

Vicore Pharma Holding AB (STO: VICO) presented the trial-design abstract for its global 52-week Phase 2b ASPIRE trial of buloxibutid (a first-in-class oral angiotensin II type 2 receptor agonist small molecule) in idiopathic pulmonary fibrosis at the European Respiratory Society Congress 2026 on Monday September 7, 2026 in Barcelona. The randomized double-blind placebo-controlled parallel-group trial enrolled more than 360 IPF patients across 14 countries and 100 sites (29 in the United States), stratified between patients on background nintedanib standard of care and those without antifibrotic therapy. The primary endpoint is change in forced vital capacity (FVC) over 52 weeks, the regulatory endpoint for IPF. Buloxibutid activates AT2R to promote alveolar-epithelial-cell repair and downregulate aberrant fibrotic signalling. Enrollment completed in April 2026; topline results are guided for mid-2027 with cash runway into H2 2028. The ASPIRE readout will land in a crowded IPF competitive landscape following the March 2026 FDA approval of Boehringer's nerandomilast (BI 1015550) as the first non-antifibrotic mechanism approved for IPF in over a decade.

#vicore-pharma #vico #buloxibutid #at2r-agonist #aspire-trial #phase-2b-design #idiopathic-pulmonary-fibrosis #ipf #fvc-endpoint #52-weeks #360-patients #nintedanib-background #ers-congress-2026 #nerandomilast-context #non-peptide
Clinical Trials

Insmed Presents Late-Breaking Phase 3b ENCORE ARIKAYCE Data in Newly Diagnosed MAC Lung Disease at ERS Congress Sunday September 6

Insmed Incorporated (NASDAQ: INSM) presented late-breaking Phase 3b ENCORE results for ARIKAYCE (amikacin liposome inhalation suspension) in an oral session Sunday September 6, 2026 at the European Respiratory Society Congress in Barcelona. The 12-month study evaluated ARIKAYCE plus multidrug therapy (azithromycin 250 mg plus ethambutol 15 mg/kg) versus multidrug therapy alone in patients with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics — a substantially different population from ARIKAYCE's current U.S. label limited to refractory MAC. ENCORE met its primary endpoint of improvement in respiratory symptom score at month 13 and all multiplicity-controlled secondary endpoints; culture conversion at month 6 was 87.8% with ARIKAYCE plus multidrug versus 57.0% with multidrug alone. Insmed plans to file a supplemental new drug application in the second half of 2026 to expand the U.S. label to newly diagnosed MAC lung disease and convert the current accelerated approval in refractory MAC to traditional approval. Five Insmed abstracts total were accepted at the meeting including brensocatib (Brinsupri, DPP1 inhibitor) bronchiectasis analyses.

#insmed #insm #arikayce #amikacin-liposome-inhalation #encore-phase-3b #mac-lung-disease #newly-diagnosed-mac #12-month-therapy #primary-endpoint-met #87-8-percent-culture-conversion #snda-h2-2026 #label-expansion #brensocatib #brinsupri #ers-congress-2026 #non-peptide
Research

Trevi Therapeutics Presents Phase 2b CORAL Quality-of-Life Data for Haduvio Nalbuphine ER in IPF Chronic Cough at ERS Congress

Trevi Therapeutics (NASDAQ: TRVI) confirmed via its September 3, 2026 conference-participation announcement that Marlies Wijsenbeek MD PhD (Erasmus MC) will deliver an oral presentation on quality-of-life outcomes measured by the Leicester Cough Questionnaire (LCQ) from the Phase 2b CORAL trial of nalbuphine extended-release (Haduvio, an oral kappa-opioid agonist / mu-opioid antagonist) in idiopathic pulmonary fibrosis patients with chronic cough at the European Respiratory Society Congress in Barcelona. The 165-patient Phase 2b CORAL topline (reported June 2025) documented statistically significant reductions in 24-hour objective cough frequency across all Haduvio dose groups at week 6, with reductions seen at week 2 (the first time point measured). Trevi has completed the End-of-Phase 2 FDA meeting and continued Phase 3 initiation preparation through 2026. Chronic cough affects approximately 85% of IPF patients and has no FDA-approved treatment; the Merck-Bellus P2X3 antagonist gefapixant (Lyfnua) was approved for refractory chronic cough in adults in 2024 but was not developed for IPF-specific cough.

#trevi-therapeutics #trvi #haduvio #nalbuphine-er #coral-phase-2b #ipf-chronic-cough #leicester-cough-questionnaire #quality-of-life #165-patients #gefapixant-context #kappa-opioid-agonist #ers-congress-2026 #non-peptide