Clinical trial coverage on Peptide News Digest pulls in Phase 1 through Phase 3 readouts across the peptide universe — GLP-1 obesity and cardiometabolic trials (SELECT, SURMOUNT-4, ACHIEVE-3, REDEFINE-1, SYNCHRONIZE-1), peptide vaccine work (AMPLIFY-201, MEL39), peptide-drug conjugate trials, and antimicrobial peptide programs.
Most of the noise sits with Lilly and Novo, but the interesting reads are usually elsewhere: Bicycle Therapeutics on solid tumors, Lirum on Ewing sarcoma, Cerapedics on lumbar fusion, Pelage on hair loss. Real-world evidence and registry data also land here when they reframe what the randomized trials showed.
Each entry names the sponsor, the phase, and the endpoint. Browse the latest below, or jump to the readouts by drug at #semaglutide, #tirzepatide, or #orforglipron.
Mabwell Biosciences presented at the European Respiratory Society Congress 2026 in Barcelona (September 5-9, 2026) — with syndicated press coverage continuing through Saturday September 12 — Phase 1b/2a results for 9MW1911, an anti-ST2 monoclonal antibody developed on Mabwell's B-lymphocyte screening platform in China. In the 9MW1911-C03 study of former smokers with moderate-to-severe COPD, the annualized rate of moderate-to-severe exacerbations was reduced by 81% at the 900 mg dose and 24% at the 600 mg dose versus placebo; annualized severe exacerbation rate reductions were 100% and 47% respectively. The Phase 3 trial is expected to initiate around end of 2026 in China; the FDA has cleared the IND application for a Phase 2a U.S. trial. 9MW1911 targets ST2 (the IL-33 receptor) — the same biological pathway targeted by Regeneron/Sanofi's itepekimab and GSK's depemokimab in COPD. Sanofi and Regeneron's Phase 3 AERIFY-1 and AERIFY-2 itepekimab trials in COPD had mixed results reported May 2025; Mabwell's data support continued ST2 blockade testing in the disease.
Corbus Pharmaceuticals (NASDAQ: CRBP) enters the weekend before Monday September 14, 2026 at 8:00 a.m. EDT conference call disclosing Phase 1b CANYON-1 topline data for CRB-913 (once-daily oral peripherally-restricted CB1 inverse agonist for obesity). The 16-week double-blind placebo-controlled dose-ranging study enrolled 240 obese non-diabetic U.S. adults across once-daily doses of 20 mg, 40 mg, and 60 mg (titrated from 20 mg) with a 4-week safety follow-up (NCT07310901). Harold Bays MD (investigator) will join Corbus management on the call. Investor focus is on the CB1 inverse agonist class safety-versus-efficacy trade-off — the peripheral restriction (approximately 15-fold lower brain penetration than monlunabant in preclinical models) is designed to preserve dose-responsive weight loss while limiting the psychiatric side effects that led to the 2008 withdrawal of Sanofi's Acomplia (rimonabant). Clean tolerability plus dose-responsive weight loss would enable Phase 2 initiation and position CRB-913 as a differentiated non-incretin add-on or alternative to the GLP-1 class. Monday's readout is one of the most-watched non-GLP-1 obesity data points on the September calendar.
AbbVie (NYSE: ABBV) announced Friday September 11, 2026 positive topline results from the Phase 3 LUNA trial evaluating Qulipta (atogepant, an oral calcitonin gene-related peptide receptor antagonist small molecule) for the preventive treatment of menstrual migraine in adults. LUNA is a multicenter randomized double-blind placebo-controlled trial that enrolled 468 adult women with pure menstrual migraine or menstrually-related migraine across sites in Europe and Asia; participants took atogepant for 7 consecutive days starting 3 days before the onset of menses, repeated over 3 menstrual cycles. Atogepant reduced perimenstrual migraine days by a mean of 1.20 days versus 0.40 days with placebo (0.80 fewer migraine days versus placebo, p<0.0001) and met all 8 ranked secondary endpoints (p<0.0001). No treatment is currently FDA-approved specifically for menstrual migraine. AbbVie plans to submit the LUNA data to health authorities and present at future medical congresses. Qulipta is already approved in the U.S. for adults with episodic migraine and chronic migraine — the LUNA readout supports a distinct short-term perimenstrual dosing regimen and potentially a dedicated label expansion. CGRP is a neuropeptide involved in migraine pathophysiology; atogepant is a small-molecule CGRP receptor antagonist rather than a peptide itself.
Corbus Pharmaceuticals (NASDAQ: CRBP) announced Friday September 11, 2026 that the company will host a conference call and webcast Monday September 14 at 8:00 a.m. EDT to discuss topline data from the Phase 1b CANYON-1 trial of CRB-913 (a once-daily orally-administered peripherally-restricted CB1 inverse agonist for obesity). The 16-week double-blind placebo-controlled dose-ranging study enrolled 240 obese non-diabetic U.S. adults at once-daily doses of 20 mg, 40 mg, and 60 mg with 4-week safety follow-up (NCT07310901). Last patient last visit was reported August 4, 2026. Harold Bays MD (investigator) will join the call as a guest speaker. CRB-913 is designed to remain peripheral (approximately 15-fold lower brain penetration than monlunabant in preclinical models) to preserve weight-loss efficacy while limiting the psychiatric side effects that led to the 2008 withdrawal of Sanofi's Acomplia (rimonabant). The Monday readout is one of the most-watched non-incretin obesity data points on the September calendar. Clean tolerability plus dose-responsive weight loss would enable Phase 2 initiation and position CRB-913 as a differentiated add-on or alternative to the GLP-1 class.
Ascendis Pharma A/S (NASDAQ: ASND) presented Thursday September 10, 2026 at the closing day of the ESPE 2026 congress in Marseille the trial-design abstract for HighLiGHts, a Phase 3 study of lonapegsomatropin (TransCon human growth hormone, a sustained-release growth hormone prodrug branded SKYTROFA in the U.S. and marketed for pediatric growth hormone deficiency since 2021) in children with short stature or growth failure due to Turner syndrome, SHOX deficiency, small-for-gestational-age (SGA), or idiopathic short stature. The four-indication combined trial design targets patients whose short stature is not attributable to growth hormone deficiency per se, expanding beyond the current SKYTROFA U.S. label for pediatric GHD. The presentation was one of several Ascendis ESPE items following the Tuesday September 8 podium delivery of first Week 52 sentinel-cohort data from the Phase 3 reACHin trial of navepegritide (TransCon CNP) in infants with achondroplasia. Ascendis reported €55 million in Q2 2026 SKYTROFA revenue alongside €252 million from YORVIPATH and €8 million from YUVIWEL, for a €315 million combined product-revenue quarter.
Ascendis Pharma A/S (NASDAQ: ASND) announced Wednesday September 9, 2026 first Week 52 sentinel-cohort data from the Phase 3 reACHin trial of navepegritide (TransCon CNP, a sustained-release C-type natriuretic peptide prodrug branded YUVIWEL in the U.S. for ages ≥2 years) in 7 treatment-naïve, genetically confirmed infants with achondroplasia aged 0 to under 2 years (mean age 11.7 months). At 100 μg/kg/week once-weekly dosing, the sentinel cohort reached 9.9 cm/year annualized growth velocity through Week 52; ACH-specific supine length Z-score improved by +0.42 from baseline; mean sagittal foramen magnum diameter increased by +3.15 mm with all children stable or improved on the Achondroplasia Foramen Magnum Score, and no decompression surgeries during the treatment period. Safety: no injection-site reactions, no deaths, no fractures, no bone-related events, no symptomatic hypotension. No treatment-related adverse events were reported and no trial discontinuations occurred. Genevieve Baujat MD (Necker Hospital) presented the data as podium abstract FC4.6 on Tuesday September 8. Full reACHin double-blind enrollment is complete with a 52-week extension ongoing. YUVIWEL was FDA-approved February 2026 for ages ≥2 years; the EMA decision on achondroplasia is anticipated Q4 2026.
Insmed Incorporated (NASDAQ: INSM) presented Wednesday September 9, 2026 at the ERS Congress in Barcelona a post-hoc analysis of the Phase 3 ASPEN trial evaluating BRINSUPRI (brensocatib, a first-in-class oral dipeptidyl peptidase 1 (DPP1) inhibitor approved in August 2025 for non-cystic fibrosis bronchiectasis (NCFB) in ages 12+) in the subgroup of ASPEN patients with prior nontuberculous mycobacterial (NTM) infection. The analysis is one of five Insmed abstracts at the meeting, alongside a COMPERA 2.0 risk-assessment post-hoc analysis of treprostinil palmitil inhalation powder (TPIP) in pulmonary arterial hypertension, additional ARIKAYCE (amikacin liposome inhalation) data on the psychosocial burden and healthcare resource use of MAC lung disease, and treatment-pattern analyses. Brinsupri launched August 2025 via specialty pharmacy in the U.S. and is under EMA and MHRA review with Japanese filing in H2 2026. TPIP is Insmed's mid-stage prostacyclin analog delivered via dry powder inhaler, targeting PAH as a differentiated option relative to United Therapeutics' Tyvaso (nebulized treprostinil).
Pulmovant, a Roivant Sciences (NASDAQ: ROIV) company, announced Tuesday September 8, 2026 that the Phase 2 PHocus study of inhaled mosliciguat (a once-daily first-in-class inhaled soluble guanylate cyclase activator) met its primary endpoint in patients with pulmonary hypertension associated with interstitial lung disease. Placebo-adjusted pulmonary vascular resistance reduction was 56.3% at Week 16 (-51.3% mosliciguat vs +6.6% placebo, p<0.0001) — the largest PVR reduction reported in any randomized controlled pulmonary hypertension trial per Pulmovant. Secondary endpoints: placebo-adjusted six-minute walk distance +35.2 meters (p=0.0027) and NT-proBNP -357.7 pg/mL, a 53.2% reduction from baseline (p=0.0002). At Week 24 (exploratory), 6MWD was +52.7 meters placebo-adjusted and NT-proBNP was -487.1 pg/mL (-75.9%). Mosliciguat was well-tolerated with lower cough incidence (12.1%) than placebo (18.2%). The trial enrolled 135 patients across 87 sites in 20 countries. The Phase 3 PHrontier study is enrolling approximately 375 patients globally in a 1:1 randomized double-blind placebo-controlled design. Marc Humbert (Université Paris-Saclay) presented the data at the ERS Congress in Barcelona; Roivant shares closed up approximately 17% on the day. Mosliciguat activates sGC independently of heme and nitric oxide, differentiating it from sGC stimulators like riociguat.
Structure Therapeutics (NASDAQ: GPCR) reported Tuesday September 8, 2026 positive data across two lead oral small-molecule obesity programs. Aleniglipron (oral small-molecule GLP-1 receptor agonist, formerly GSBR-1290) reached mean 16.2% body weight loss at 72 weeks at the 180 mg dose in the ACCESS Phase 2b open-label extension (11.6% at 45 mg, 14.4% at 90 mg), with no observed weight-loss plateau; fewer than 5% of participants discontinued for adverse events using the improved 2.5 mg starting dose with four-week titration. The Phase 3 ACCOMPLISH program enrolls up to 3,600 adults with obesity plus comorbidity (ACCOMPLISH-1) and up to 1,100 with obesity plus type 2 diabetes (ACCOMPLISH-2), with topline expected H2 2028. Separately, ACCG-2671 (oral small-molecule dual amylin and calcitonin receptor agonist) posted first-in-human Phase 1/2a single-ascending-dose data in 31 healthy volunteers: 3.3% body weight reduction after a single 10 mg dose at Day 24, ~6-day half-life supporting once-weekly dosing, CTX-1 bone resorption biomarker reduction ~60% by Day 2, no serious adverse events, no drug-induced liver injury, no nausea or vomiting at 1-2 mg doses (dose-related GI effects at 5+ mg). A 12-week multiple-ascending-dose trial in obese participants is enrolling with topline expected H1 2027. Despite the data, GPCR shares fell in Tuesday trading on incumbent-class competitive concerns.
Ascendis Pharma A/S (NASDAQ: ASND) presented first sentinel-cohort data from the Phase 3 reACHin trial of navepegritide (TransCon CNP, a sustained-release C-type natriuretic peptide prodrug branded YUVIWEL in the U.S. for achondroplasia in children ≥2 years) in infants aged 0 to under 2 years at the ESPE 2026 congress in Marseille on Tuesday September 8, 2026 (abstract FC4.6, 3:00-4:00 p.m. CEST podium session; Genevieve Baujat MD, Necker Hospital, presenting). The reACHin study completed target enrollment and extends navepegritide's tested age range down to infancy, the population most vulnerable to achondroplasia complications from cervicomedullary compression, foramen magnum stenosis, and delayed motor milestones. Additional ESPE 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; two poster presentations on adolescent hypoparathyroidism patient-reported outcomes; and a systematic literature review on pediatric growth hormone deficiency prevalence. Ascendis' TransCon franchise generated €315 million in Q2 2026 product revenue (+105% year-over-year) with YUVIWEL contributing €8 million in its first U.S. commercial quarter.
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 (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.
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.
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.
Novartis (NYSE: NVS) initiated clinical holds on all rap-cel (YTB323, an autologous CD19-directed CAR-T cell therapy) autoimmune trials on August 24, 2026 following three fatal cases of immune effector cell-associated hemophagocytic syndrome, a rare life-threatening inflammatory reaction. Affected trials cover lupus (systemic lupus erythematosus), myasthenia gravis, multiple sclerosis, systemic sclerosis, idiopathic inflammatory myopathies, and additional autoimmune indications. Bristol Myers Squibb (NYSE: BMY) voluntarily paused enrollment in its own zola-cel (zolacabtagene autoleucel, another autologous CD19 CAR-T) autoimmune trials after detecting transient and reversible inflammatory events during routine safety surveillance; BMS had halted the enrollment in June 2026 after cases of brain inflammation but did not publicly disclose the pause until three months later. Novartis and BMS were the leading commercial-scale CAR-T-in-autoimmune-disease players; the paired pauses are a substantial setback for the category, which had been the hottest cell-therapy expansion area of 2026 after Kyverna, Cabaletta Bio, and multiple academic centers reported dramatic clinical responses in refractory lupus and neurological autoimmune disease.
Corbus Pharmaceuticals (NASDAQ: CRBP) continued through Sunday September 6, 2026 the countdown to CANYON-1 Phase 1b topline data for CRB-913 (a once-daily orally-administered peripherally-restricted CB1 inverse agonist for obesity). Last patient last visit was announced August 4, 2026, and topline is expected in September 2026 per company Q2 2026 corporate update — the specific readout date has not been disclosed but the September window narrows with each passing day. The 16-week double-blind placebo-controlled dose-ranging study enrolled 240 obese non-diabetic U.S. adults at once-daily doses of 20 mg, 40 mg, and 60 mg with 4-week safety follow-up. CRB-913 is engineered to remain peripheral (approximately 15-fold lower brain penetration than monlunabant in preclinical models) to preserve efficacy while limiting the psychiatric side effects that led to withdrawal of Sanofi's Acomplia (rimonabant) in 2008. Investor focus is on the CB1 inverse agonist class safety-versus-efficacy trade-off plus dose-responsive weight loss. Clean data enables Phase 2 initiation and would position CRB-913 as a non-incretin add-on or alternative to the GLP-1 class.
Novartis (NYSE: NVS) announced Friday September 4, 2026 that the pelacarsen Phase 3 Lp(a)HORIZON trial did not meet its primary endpoint of reducing major adverse cardiovascular events (a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and urgent coronary revascularization requiring hospitalization) versus placebo in patients with elevated lipoprotein(a) plus established cardiovascular disease on guideline-directed background therapy including lipid-lowering and antihypertensive medications. Pelacarsen (an antisense oligonucleotide targeting hepatic APO(a) production, licensed from Ionis Pharmaceuticals in 2019) did achieve substantial lower Lp(a) levels versus placebo. The trial enrolled roughly 8,000 patients globally over 6 years and represents the largest and most consequential test to date of the Lp(a)-as-causal-cardiovascular-risk-factor hypothesis. The miss substantially raises the bar for Amgen's olpasiran (RNAi, Phase 3 OCEAN(a) ongoing), Silence Therapeutics's zerlasiran (RNAi), and Lilly's lepodisiran (RNAi) — all of which are testing similar Lp(a)-lowering-plus-cardiovascular-outcome frameworks. Ionis and Royalty Pharma both hold economic interests in pelacarsen.
Corbus Pharmaceuticals (NASDAQ: CRBP) continued through Saturday September 5, 2026 the countdown to CANYON-1 Phase 1b topline data for CRB-913 (a once-daily orally-administered peripherally-restricted CB1 inverse agonist for obesity). Last patient last visit was announced August 4, 2026, and topline is expected in September 2026 per company Q2 2026 corporate update. The 16-week double-blind placebo-controlled dose-ranging study enrolled 240 obese non-diabetic U.S. adults at once-daily doses of 20 mg, 40 mg, and 60 mg with 4-week safety follow-up. CRB-913 is engineered to remain peripheral (approximately 15-fold lower brain penetration than monlunabant in preclinical models) to preserve efficacy while limiting the psychiatric side effects that led to withdrawal of Sanofi's Acomplia (rimonabant) in 2008. The readout is one of the most-watched non-incretin obesity data points on the September calendar. Clean tolerability plus dose-responsive weight loss would enable Phase 2 initiation and set up CRB-913 as a differentiated add-on or alternative to the GLP-1 class.