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.
Amgen (NASDAQ: AMGN) continued enrollment through September 2026 in the dedicated MARITIME switch trial that specifically tests whether patients currently on weekly semaglutide (Ozempic, Wegovy) or tirzepatide (Mounjaro, Zepbound) can be converted to monthly MariTide (maridebart cafraglutide, antibody-peptide conjugate combining GLP-1 receptor agonism with GIP receptor antagonism) with equivalent weight-loss maintenance and comparable tolerability. Filing for FDA approval is planned late 2026 to early 2027 with anticipated launch 2027-2028. Six total Phase 3 MariTide trials are enrolling across obesity (MARITIME-1), obesity plus type 2 diabetes (MARITIME-2), cardiovascular outcomes (MARITIME-CVD), heart failure (MARITIME-HF), obstructive sleep apnea (MARITIME-OSA), plus the switch trial. Cantor Fitzgerald analyst commentary earlier in 2026 had flagged a 4% bone mineral density decline signal from Phase 1 as a factor to watch; Phase 3 data on bone health will affect prescribing guidance especially for adults over 60 or with prior fracture history.
AbbVie (NYSE: ABBV) announced Thursday September 3, 2026 positive topline results from the Phase 3 CERVINO trial of etentamig (an investigational monthly-dosed BCMA x CD3 bispecific T-cell engager) versus investigator's choice of standard available therapies in patients with triple-class-exposed relapsed/refractory multiple myeloma. The 393-patient trial met both dual primary endpoints: 74% objective response rate versus standard therapies plus a 60% reduction in the risk of disease progression or death (hazard ratio 0.40). Median follow-up was 11.4 months; safety was manageable with cytokine release syndrome and infection rates consistent with the BCMA bispecific class. Full CERVINO data will be presented in a plenary session at the 23rd International Myeloma Society Annual Meeting September 23-26, 2026 in Glasgow, Scotland. Etentamig would enter a competitive BCMA bispecific field led by Johnson & Johnson's Tecvayli (teclistamab) and Elrexfio (elranatamab, Pfizer), with the monthly dosing profile positioned as convenience-differentiated versus the weekly and biweekly regimens of the incumbents.
Akeso (HKEX: 9926) and Summit Therapeutics (NASDAQ: SMMT) announced Thursday September 3, 2026 that the pre-specified interim overall survival analysis in the Phase 3 HARMONi-2 trial of ivonescimab (a first-in-class PD-1/VEGF bispecific antibody) met the key secondary endpoint of OS versus Merck's Keytruda (pembrolizumab) in first-line PD-L1-positive metastatic non-small cell lung cancer in China. Ivonescimab demonstrated statistically significant and clinically substantive improvement over pembrolizumab; specific hazard ratio and median OS numbers will be released at an upcoming medical meeting. The primary progression-free survival analysis reported earlier had shown ivonescimab reduced the risk of disease progression or death by 49% with median PFS of 11.14 months versus 5.82 months on pembrolizumab. HARMONi-2 is the fourth Phase 3 trial for ivonescimab to meet its OS endpoint (following biliary tract cancer and two other tumor types). The readout is the first head-to-head Phase 3 OS win for any drug versus Keytruda in first-line NSCLC and reshapes the competitive framing for the emerging PD-1/VEGF bispecific class.
Corbus Pharmaceuticals (NASDAQ: CRBP) continued through Friday September 4, 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. A clean tolerability profile 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.
Ultragenyx Pharmaceutical (NASDAQ: RARE) announced Wednesday September 2, 2026 that the Phase 3 Aspire study of apazunersen (GTX-102, an intrathecally-administered antisense oligonucleotide designed to reduce production of the paternal UBE3A antisense transcript in Angelman syndrome) did not meet its primary endpoint of change from Baseline in Bayley-4 cognitive raw score, nor its key secondary endpoint of Multidomain Responder Index (MDRI) net response. The 129-patient trial enrolled ages 4 to 17 with genetically confirmed full maternal UBE3A gene deletion. Safety was consistent with the Phase 1/2 program. The result is the first Phase 3 miss for an antisense drug in Angelman syndrome and closes off the primary regulatory path for GTX-102 in the enrolled population. Ultragenyx will discuss next steps with regulators and continues the Aurora study evaluating GTX-102 in additional Angelman syndrome genotypes and age groups. RARE shares fell substantially in premarket trading. The failure joins Roche/Ionis's tominersen Huntington's disease miss (GENERATION HD1, 2022) and Sage-Biogen's zuranolone MDD approval-with-restrictions as instances where CNS antisense programs failed to translate promising Phase 1/2 signals into Phase 3 wins.
Corbus Pharmaceuticals (NASDAQ: CRBP) continued through Thursday September 3, 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. 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. A clean tolerability profile plus dose-responsive weight loss would enable Phase 2 initiation and set up CRB-913 as a differentiated add-on or alternative to the incretin class.
Enveda Biosciences (Boulder, Colorado; AI-enabled natural product discovery platform) continues to draw attention through September 2026 for ENV-308, the first-in-class oral small-molecule mimetic of Lac-Phe (N-lactoyl-phenylalanine, an exercise-produced signaling molecule) whose Phase 1 safety and tolerability data was reported August 18, 2026. The Phase 1 trial in 88 healthy volunteers showed ENV-308 was well-tolerated with low GI side effects and reduced circulating leptin as a biomarker signal that the drug reaches metabolically-active concentrations in humans. In preclinical animal studies, ENV-308 preserved lean muscle during weight loss and prevented weight regain after weight-loss therapy was stopped. Enveda cites the statistic that roughly 1 in 8 U.S. adults have used a GLP-1 medication and most stop within a year for cost, side-effect, or plateau reasons. Phase 2 will test whether ENV-308 helps people maintain weight after stopping GLP-1s. Timeline: realistic earliest approval 2028-2029. ENV-308 joins bimagrumab (Eli Lilly, anti-activin receptor Phase 3), HM17321 (Hanmi-Genentech UCN2 analog, Phase 1), and ARO-INHBE (Arrowhead RNAi, Phase 1/2a) in the muscle-preservation pipeline.
Boehringer Ingelheim continues enrollment through September 2026 in the Phase 2 clinical trial of BI 3034701 (a potential first-in-class GLP-1/GIP/NPY2 triple receptor agonist), which the company initiated in July 2026 as part of the expanded obesity pipeline anchored on survodutide (dual GLP-1/glucagon agonist, in Phase 3 MASH with Zealand Pharma partnership). BI 3034701 was discovered via the Boehringer-Gubra Biopharmaceutical peptide discovery collaboration and is designed to engage the NPY2 receptor alongside GLP-1 and GIP receptors — a differentiated triple-target mechanism versus Eli Lilly's retatrutide (GIP/GLP-1/glucagon) and Hengrui's ribupatide (GIP/GLP-1/glucagon). The NPY2 receptor pathway is involved in central appetite regulation and has been targeted historically by hormones including PYY(3-36); Boehringer positions BI 3034701 as engaging appetite regulation through a complementary mechanism to the incretin axis. Phase 2 readout timing has not been publicly disclosed. Boehringer Ingelheim's overall obesity pipeline positions the company as a distant third-place challenger to Eli Lilly and Novo Nordisk with survodutide, BI 3034701, and the emerging GLP-1/glucagon dual agonist program.
Teva Pharmaceutical Industries (NYSE: TEVA) announced Wednesday September 2, 2026 positive topline results from the ongoing Phase 2a study of TEV-408 (an investigational anti-interleukin-15 monoclonal antibody) in adults with celiac disease already following a gluten-free diet. The 50-patient study met its primary endpoint by demonstrating statistically significant and clinically substantive prevention of gluten-induced intestinal damage versus placebo at Week 8. Key efficacy: LS mean change from baseline in intraepithelial lymphocyte (IEL) density was +27.60 for placebo versus +0.37 for TEV-408 (treatment difference -27.23, 95% CI: -39.67 to -14.79). TEV-408 also demonstrated lower gastrointestinal symptom scores versus placebo on the patient-reported Celiac Disease Symptom Diary. Safety was clean with no signals observed. TEV-408 received FDA Fast Track designation in May 2025 and represents a novel mechanism in celiac disease where no disease-modifying therapies are approved and standard-of-care remains strict gluten-free diet adherence. Teva positioned the win as further validation of its 'pipeline-in-a-product' anti-IL-15 platform strategy.
Inventiva SA (NASDAQ: IVA) announced Wednesday September 2, 2026 completion of the last patient's final 72-week visit in the Phase 3 NATiV3 study of lanifibranor (a pan-PPAR α/δ/γ agonist) in adults with biopsy-proven non-cirrhotic MASH and F2/F3 fibrosis. Enrollment: 1,009 patients in the main cohort plus an additional 410 patients in the exploratory cohort. NATiV3 assesses lanifibranor on histological endpoints including MASH resolution and improvement of fibrosis of at least one stage after 72 weeks of treatment. Inventiva expects to report topline data in Q4 2026 with NDA filing planned for H1 2027. Lanifibranor differentiates from the standard-of-care Madrigal Rezdiffra (resmetirom, THR-β agonist, approved March 2024) plus the emerging Boehringer Ingelheim survodutide, Novo Nordisk semaglutide MASH, and Akero Therapeutics efruxifermin (FGF21) programs by engaging three complementary PPAR isoforms in parallel to address steatosis, inflammation, and fibrosis.
Ascletis Pharma (HKEX: 1672) continued enrollment through early September 2026 in the two U.S. Phase 1 studies of ASC36 (a once-monthly to once-quarterly subcutaneous amylin receptor peptide agonist for obesity) and ASC36_35FDC (a once-monthly subcutaneous fixed-dose combination of ASC36 plus GLP-1R/GIPR peptide agonist ASC35) initiated August 10, 2026 following FDA IND clearance July 5. In head-to-head diet-induced-obesity rat studies, ASC36 monotherapy demonstrated approximately 91% greater relative body weight reduction versus Zealand-Roche's petrelintide and approximately 32% greater versus Eli Lilly's eloralintide. If the Phase 1 tolerability profile confirms preclinical differentiation, ASC36 would enter the amylin analog Phase 2 field alongside Novo Nordisk's cagrilintide-in-CagriSema, AstraZeneca's AZD6234 (Milan EASD 2026 September 28-October 2 readout), Metsera's MET-233i, and the Roche-Zealand petrelintide-plus-enicepatide combination Phase 2 initiation planned mid-2026.
Novartis (NYSE: NVS) announced Tuesday September 1, 2026 that the twin REMODEL-1 and REMODEL-2 Phase 3 trials of remibrutinib (an oral, selective, high-efficacy Bruton's tyrosine kinase inhibitor) met both primary endpoints in relapsing multiple sclerosis, with remibrutinib demonstrating statistically significant superiority versus teriflunomide (Aubagio) in reducing annualized relapse rate (ARR) and inflammatory brain MRI lesions. Key secondary endpoints related to disability progression trended in favor of remibrutinib, with nominal significance in 6-month confirmed disability progression (6mCDP) in a preplanned pooled analysis. Safety was clean: no liver-safety signal and no cases meeting Hy's Law criteria across a broader remibrutinib development program that has now enrolled more than 4,500 participants across neurologic and immune-mediated indications. Full REMODEL-1/-2 data will be presented at MSToronto2026 (ECTRIMS-ACTRIMS joint meeting, October 21-23, Toronto). Regulatory submissions will follow. The readout positions remibrutinib as a potential oral option in a category currently anchored by injectable anti-CD20 therapies (Ocrevus, Kesimpta, Briumvi) plus Sanofi's Aubagio and the sphingosine-1-phosphate receptor modulators.
Alumis (NASDAQ: ALMS) announced Tuesday September 1, 2026 that the Phase 2b LUMUS trial of envudeucitinib (an oral allosteric TYK2 inhibitor designed to correct immune dysregulation across IL-23, IL-17, and Type I interferon pathways) failed to meet the primary endpoint of British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at Week 48 in patients with systemic lupus erythematosus (n=408). All secondary objectives also missed. Strong responses were observed in the pre-specified high-interferon-gene-signature subgroup (which characterizes a majority of moderate-to-severe SLE patients), but IFNGS-high patients were under-represented in the overall trial population which reduced the treatment effect. Alumis (ALMS) shares fell approximately 55% and erased more than $1.6 billion of market capitalization. The company will meet with regulators to discuss a Phase 3 SLE path targeting the IFNGS-high subgroup and remains on track to submit the envudeucitinib NDA for moderate-to-severe plaque psoriasis in Q4 2026 following the Phase 3 ONWARD program win.
Corbus Pharmaceuticals (NASDAQ: CRBP) confirmed Tuesday September 1, 2026 that the CANYON-1 Phase 1b topline data readout for CRB-913 (a once-daily orally-administered highly peripherally-restricted CB1 inverse agonist for obesity) remains on track for September 2026, following completion of the last patient last visit announced August 4. The CANYON-1 study is a 16-week double-blind placebo-controlled dose-ranging trial in 240 obese non-diabetic U.S. adults testing once-daily oral doses of 20 mg, 40 mg, and 60 mg versus placebo with dose titration and 4-week safety follow-up. CRB-913 is engineered to remain peripheral (approximately 15-fold lower brain penetration than the CB1 inverse agonist monlunabant in preclinical models) to preserve efficacy while limiting the psychiatric side effects that led to the withdrawal of Sanofi's Acomplia (rimonabant) in 2008. The mechanism is designed to complement or serve as an alternative to GLP-1 receptor agonists, and the CANYON-1 tolerability profile will determine whether Corbus advances CRB-913 into Phase 2 later in 2026.
BioVie Inc. (NASDAQ: BIVI) announced Monday August 31, 2026 completion of the last on-treatment visit in the ADDRESS-LC Phase 2 trial evaluating Bezisterim (a small-molecule insulin-sensitizer developed for the treatment of neurological symptoms of Long COVID). The Phase 2 study enrolled approximately 200 patients to evaluate whether Bezisterim can reduce brain fog, fatigue, and other lingering neurological symptoms after SARS-CoV-2 infection, and is fully funded by a grant from the U.S. Department of War (formerly Department of Defense). With the last patient's treatment visit complete and the one-month virtual follow-up nearly complete, BioVie anticipates topline results before end of September 2026. Not a peptide, but the readout is relevant to the peptide-industry Long COVID pipeline (LSALT peptide, BPC-157 for post-viral inflammation) and reflects the broader Department of War / BARDA interest in post-acute infection syndrome treatments.
Enveda Biosciences (Boulder, Colorado, AI-enabled natural product discovery platform) reported positive Phase 1 results August 18, 2026 for ENV-308, a first-of-its-kind oral small molecule engineered to mimic the therapeutic effects of Lac-Phe (a hormone released during intense exercise) for the treatment of post-GLP-1 weight regain and lean-mass loss. In the Phase 1 trial (n=88 healthy volunteers), ENV-308 was extremely well tolerated including on gastrointestinal safety, and reduced circulating leptin as an exploratory metabolic-engagement signal. In animal studies, ENV-308 preserved lean muscle during weight loss and prevented weight regain after weight-loss therapy was stopped. Enveda cites the statistic that 1 in 8 U.S. adults use GLP-1 medications and the majority who take them for weight loss stop within one year. Phase 2 will test whether ENV-308 can help people maintain weight after stopping GLP-1s. Not a peptide, but the exercise-mimetic pathway is one of the leading commercial answers to the muscle-preservation and post-discontinuation regain problems that constrain the current peptide obesity therapeutic class.
AstraZeneca (NASDAQ: AZN) and Ionis Pharmaceuticals (NASDAQ: IONS) presented Sunday August 30, 2026 at ESC Congress 2026 Munich the detailed subgroup analyses from the Phase 3 CARDIO-TTRansform trial of Wainua (eplontersen, an antisense oligonucleotide targeting transthyretin) in adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). CARDIO-TTRansform did not meet its primary composite endpoint (cardiovascular mortality plus recurrent CV events through 140 weeks) versus placebo. In the prespecified subgroup analysis, patients receiving eplontersen monotherapy achieved a nominally significant hazard ratio of 0.71 versus placebo, while patients on background TTR stabilizer therapy (tafamidis, Vyndaqel/Vyndamax) at baseline showed no treatment effect. The read-out complicates the silencer-plus-stabilizer commercial approach in ATTR-CM that Alnylam's HELIOS-B trial of vutrisiran validated with 28.2% mortality reduction and 32.8% CV event reduction on background tafamidis. AstraZeneca and Ionis will analyze the full dataset to inform next steps in the CARDIO-TTRansform program.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) presented Sunday August 30, 2026 the full Phase 3 SHASTA-3 and SHASTA-4 12-month data of plozasiran (an RNAi therapeutic targeting APOC3, administered as quarterly subcutaneous injection) in adults with severe hypertriglyceridemia at the European Society of Cardiology Congress 2026 in Munich, Germany, in a Hot Line Late-Breaking Science session. SHASTA-3 and SHASTA-4 met their primary and all prespecified secondary endpoints with median triglyceride reductions from baseline of 79% and 81%, respectively, at Month 12 (p<0.0001 in both studies). More than 90% of plozasiran-treated patients achieved triglycerides below 500 mg/dL at Month 12, and more than half achieved TG below 150 mg/dL. In a prespecified pooled analysis, plozasiran significantly reduced acute pancreatitis events across the broad sHTG study population, with greater absolute benefit among higher-AP-risk patients. Three fatal events in the plozasiran arm (two cardiovascular deaths, one CMML death) were assessed as unrelated to study treatment. Arrowhead plans to file a supplemental NDA before end of 2026 for the broader sHTG population, building on the earlier familial chylomicronemia syndrome approval.