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.
On July 7, Kailera Therapeutics reported positive topline results from two Hengrui Pharma Phase 3 trials in China of HRS-7535/KAI-7535, a once-daily oral small-molecule GLP-1 receptor agonist licensed to Kailera outside Greater China. In HARBOR-1, 556 adults with obesity or overweight lost a mean 9.5% of body weight at 120 mg and 10.9% at 180 mg by week 44. OUTSTAND-2, in 810 adults with type 2 diabetes, showed HbA1c reductions of 1.50% to 1.68% and non-inferiority versus dapagliflozin. Hengrui plans China NDA filings; Kailera is running a parallel global Phase 2.
A Phase 1/2 study (NCT07637786) of ONVAX-01, a personalized peptide nanovaccine, in combination with an anti-PD-1 antibody and standard-of-care chemotherapy in patients with advanced pancreatic cancer began recruiting in late June 2026. The trial design has participants receive doses of the nanovaccine along with intravenous infusions of an anti-PD-1 checkpoint inhibitor plus chemotherapy, with serial imaging and blood-marker monitoring for tumor response. ONVAX-01 sits in the same broad therapeutic space as Elicio Therapeutics' ELI-002 7P (which missed its Phase 2 AMPLIFY-7P primary disease-free survival endpoint on June 15) but with a different delivery vehicle (nanoparticle self-assembly versus amphiphile-modified CpG oligonucleotide adjuvant). KRAS mutations drive approximately 90% of pancreatic ductal adenocarcinoma cases and 50% of colorectal cancers, making KRAS-targeting peptide vaccines one of the highest-impact unmet targets in solid-tumor oncology. The peptide nanovaccine modality has roots in 2022 case-report literature on neoantigen nanovaccine immunotherapy in advanced pancreatic cancer and broader nanovaccine work using DP7-C antimicrobial peptide as carrier-plus-adjuvant.
Elicio Therapeutics announced June 15, 2026 that the randomized Phase 2 AMPLIFY-7P study of ELI-002 7P (a 7-peptide formulation targeting the seven most common KRAS mutations, combined with the ELI-004 amphiphile-modified CpG oligonucleotide adjuvant) in patients with adjuvant mKRAS-driven pancreatic ductal adenocarcinoma did not meet its pre-specified primary disease-free survival (DFS) endpoint in the intent-to-treat population. Post-hoc landmark analyses, however, showed a consistent 14% absolute DFS benefit during active treatment at both 3 and 6 months, with treatment-arm separation persisting through 9 months — suggesting early clinical activity that waned over time. Elicio is refining its Phase 3 development strategy based on the data. The 7P formulation extends the 2-peptide ELI-002 2P AMPLIFY-201 program covered in this site's April 29 digest (Nature Medicine publication, durable T-cell responses, median RFS not reached vs 3.02 months in non-responders). KRAS mutations drive roughly 90% of pancreatic cancers and 50% of colorectal cancers, making the KRAS peptide vaccine class one of the highest-impact targets in solid-tumor oncology.
HLB Therapeutics (KOSDAQ: 115450) announced in late May 2026 that its US subsidiary ReGenTree failed to meet the primary endpoint in the European Phase 3 SEER-3 trial of RGN-259, a thymosin beta-4-based eye drop designed to rival Dompé's Oxervate (cenegermin) — the only FDA-approved prescription drop for neurotrophic keratitis. The trial did not show a statistically significant difference in complete corneal healing at 4 weeks compared to placebo, with a company spokesperson telling Korea Biomedical Review that 'a stronger-than-expected placebo effect in the control arm led to a puzzling outcome.' RGN-259 is licensed from RegeneRx and is also in Phase 3 development for dry eye syndrome (ARISE-3). HLB Therapeutics CEO Ahn Gi-hong said the company will analyze the SEER-3 results and focus resources on the ongoing US Phase 3 SEER-2 trial, with topline H2 2026.
NervGen Pharma (Nasdaq: NGEN) confirmed in its Q1 2026 results (early May) that the RESTORE registrational Phase 3 study of NVG-291 in chronic tetraplegia (cervical chronic spinal cord injury, SCI) remains on track for mid-2026 initiation after a successful FDA End-of-Phase 2 meeting. NVG-291 is a subcutaneous peptide mimetic of the intracellular signaling domain of intracellular sigma peptide (ISP), designed to plasticize neural pathways and enable functional recovery in chronic SCI — a first-in-class mechanism where no pharmacological intervention has shown durable motor recovery before. The expanded chronic CONNECT SCI Phase 1b/2a data (n=10 active vs n=10 placebo) showed a three-fold increase in motor connectivity to the first dorsal interosseus hand muscle. Biomechanical gait analysis from an independent movement-intelligence firm is expected Q2 2026 to disentangle genuine neural recovery from compensatory mechanics. Cash was $16.6M as of March 31, 2026 (listed Nasdaq Jan 8, 2026).
EndoCyclic Therapeutics announced FDA clearance of the Investigational New Drug (IND) application for ENDO-205 on March 23, 2026. ENDO-205 is a first-in-class non-hormonal precision peptide therapeutic for endometriosis, designed to eliminate lesions rather than modulate hormones — distinguishing it from all currently approved endometriosis therapies, which are either oral GnRH antagonists (elagolix, relugolix) or hormonal contraceptives. In preclinical models, ENDO-205 eliminated endometriosis lesions and associated inflammation with no safety signals in GLP toxicology studies. The Phase 1 will enroll healthy pre-menopausal women of reproductive age. Endometriosis affects roughly 10% of women of reproductive age globally, with a 6-10 year average diagnostic delay and no curative therapy.
Marea Therapeutics (Endocrine News Pharma Friday, June 19) released Phase 1 first-in-human data for MAR002, a first-in-class half-life-extended allosteric human monoclonal antibody growth hormone receptor antagonist (GHRA), at ENDO 2026 in Chicago. The Phase 1 readout supports a potential best-in-disease profile across safety, tolerability, pharmacodynamic IGF-1 lowering, and pharmacokinetics, with a long duration of action compatible with infrequent subcutaneous dosing — potentially once every two weeks — versus the daily subcutaneous administration required for pegvisomant (Somavert). MAR002 sits at the intersection of acromegaly's existing somatostatin (octreotide, lanreotide, Palsonify), GH-receptor (pegvisomant), and dopamine agonist (cabergoline) approaches and reframes the GHR antagonist class around an antibody, not a pegylated protein. Acromegaly's US/EU prevalence is roughly 40-70 per million.
Recordati Rare Diseases presented four poster analyses at ENDO 2026 from the LINC clinical program for ISTURISA (osilodrostat), the oral 11β-hydroxylase inhibitor approved for Cushing's syndrome. The posters covered patient-reported quality-of-life improvements, biochemical control durability, real-world treatment outcomes across LINC 3 and LINC 4 study extensions, and clinical responses across the heterogeneous Cushing's syndrome population. ISTURISA was approved in March 2020 for Cushing's disease and expanded to broader Cushing's syndrome in April 2025; the LINC 3 pivotal study showed 86% of patients normalized urinary free cortisol after eight weeks of randomized withdrawal versus 29% with placebo. Endogenous Cushing's syndrome remains an ultra-rare endocrine disorder with limited therapeutic alternatives (ketoconazole, metyrapone, mifepristone, pasireotide).
Hanmi Pharmaceutical presented HM500197 (LA-MSTN) at ADA 2026 (June 5-8, New Orleans) as the world's first peptide-based myostatin inhibitor, positioned as a muscle-preserving adjunct to GLP-1 weight-loss therapy. The molecule was designed on Hanmi's HARP (Hanmi AI-driven Research Platform) integrating AI and structural modeling. Hanmi paired the LA-MSTN unveiling with a second next-generation candidate, HM17321, in a broader eight-abstract slate spanning the company's obesity pipeline. The myostatin angle addresses a major shortcoming of the current GLP-1 class — 25-40% of weight loss coming from lean tissue rather than fat — which Stanford's Maharjan team flagged at ENDO 2026 with the 560-step daily activity drop and which underlies the broader bone-health and frailty concerns now being studied across the GLP-1 class.
A Medscape clinical study report June 16 from Federica Vinciguerra and colleagues at the University of Catania documented that tirzepatide reversed post-bariatric-surgery weight regain in patients several years out from sleeve gastrectomy or gastric bypass. Post-surgical weight regain affects roughly 50% of bariatric patients within 2-5 years; until recently, the field had no pharmacologic option that meaningfully reversed it. The Catania data add to the case that GLP-1 incretin therapy is a credible second-line option for the post-surgical regain population, distinct from bariatric revision surgery and the 503A/503B compounded-GLP-1 channel.
Entera Bio (Nasdaq: ENTX) presented full single-tablet EB613 results on June 14 at ENDO 2026 in Chicago as a late-breaking oral. The single-tablet EB613 achieved a comparable pharmacokinetic and pharmacodynamic profile to Forteo (injectable teriparatide) and to the multi-tablet EB613 used in Entera's earlier Phase 2 study in postmenopausal women with osteoporosis. On the administration-experience quality-of-life questionnaire, 14 of 15 study participants preferred the single tablet to the multi-tablet format, and all 15 preferred the daily oral EB613 to the daily injection. Entera plans to advance the single-tablet formulation into the Phase 3 trial in 750 postmenopausal women starting late 2026, with topline expected H2 2028.
Rhythm Pharmaceuticals (Nasdaq: RYTM) presented seven setmelanotide abstracts at ENDO 2026 covering three rare-disease patient populations. Christian Roth (Seattle Children's) reported 2.5-year Phase 2 + long-term extension data in acquired hypothalamic obesity showing -18.9% mean BMI reduction across all 11 participants. The PWS interim Phase 2 (June 13) reported across 17 patients (10 adult, 7 pediatric) showed 3.11% mean BMI reduction in adults and 3.00% in pediatric patients, with 8 of 10 baseline-hyperphagic patients hitting a 7-point HQ-CT reduction, and 4.19% fat-mass loss with 0.74% lean-mass gain across 16 DEXA evaluations. Two BBS late-breaking posters from Caroline Huber covered real-world hyperphagia and healthcare-utilization outcomes from the 6-month RESTORE study. All three indications reinforce the MC4R-agonist rationale for Phase 3.
Crinetics Pharmaceuticals (Nasdaq: CRNX) presented on June 14 full results from its 12-week Phase 2 trial of atumelnant (CRN04894) in adults with classic congenital adrenal hyperplasia (CAH), the company's investigational once-daily oral ACTH receptor antagonist. The data showed rapid, substantial, and sustained statistically significant reductions in CAH disease biomarkers including androstenedione and 17-hydroxyprogesterone, with patients able to reduce glucocorticoid doses while maintaining androgen control. A separate Phase 1b/2a interim analysis in ACTH-dependent Cushing's syndrome showed that atumelnant rapidly lowered early-morning cortisol and normalized urinary free cortisol even at lower doses. Both programs are advancing toward Phase 3.
Neurocrine Biosciences (Nasdaq: NBIX) presented two-year data from CAHtalyst Pediatric showing durable hormone control, reduced glucocorticoid exposure, and improved growth measures in pediatric patients with classic congenital adrenal hyperplasia (CAH), with weight, insulin resistance, and bone-age outcomes also improved at year 2. Separately, Neurocrine announced the first retrospective case series of CRENESSITY (crinecerfont) in patients with classic CAH due to 11β-hydroxylase deficiency, the second-most-common form of CAH after 21-hydroxylase deficiency, accounting for roughly 5% of cases. The 11β-OHD subtype was not previously studied in the crinecerfont trials and is characterized by cortisol deficiency plus excess adrenal androgens and accumulation of 11-deoxycortisol and 11-deoxycorticosterone. Crinecerfont is a small-molecule CRF1 receptor antagonist that dampens the CRH-ACTH peptide signaling axis.
Crinetics Pharmaceuticals (Nasdaq: CRNX) presented data on June 14 from up to two years of efficacy and pooled safety follow-up in the PATHFNDR-1 and PATHFNDR-2 open-label extensions of Palsonify, the once-daily oral SST2 nonpeptide agonist for acromegaly. Palsonify maintained lowered IGF-1 levels, stable symptoms, and stable or reduced pituitary tumor volumes through 48 weeks across 167 patients. Pooled safety data identified no new safety signals; common adverse events were diarrhea, arthralgia, headache, and UTI. A separate ACROBAT Advance analysis showed safety and efficacy with up to four years of Palsonify + oral cabergoline combination therapy in patients whose IGF-1 had not normalized on Palsonify alone. With Camurus's rival monthly octreotide depot Oclaiz pushed to a 2027 US launch after the June 10 second CRL, Palsonify now stands alone as the next-generation acromegaly therapy in the US market.
Ascendis Pharma (Nasdaq: ASND) presented a subgroup analysis from the registrational ApproaCH trial of once-weekly TransCon CNP (navepegritide, brand name YUVIWEL) at ENDO 2026 in Chicago showing sustained annualized growth velocity (AGV) gains through two years of treatment in children 5 years and older with achondroplasia. Investigators reported significantly greater AGV at week 52 versus placebo with improvements sustained through year two. TransCon CNP was FDA-approved in February 2026 under the YUVIWEL brand to increase linear growth in pediatric patients 2 years of age and older with achondroplasia and open epiphyses. The C-natriuretic peptide prodrug is the second TransCon-platform asset approved after TransCon hGH (Skytrofa) for pediatric growth hormone deficiency.
Ascendis Pharma (Nasdaq: ASND) released June 11 the 5-year (Week 266) results from its Phase 2 PaTH Forward trial of TransCon PTH (palopegteriparatide) in adults with chronic hypoparathyroidism, ahead of formal presentation at ENDO 2026 in Chicago. At Week 266, 82% of patients met the composite endpoint of normal serum calcium without active vitamin D and with less than 600 mg/day of calcium; nearly all participants achieved independence from conventional therapy, and 95% completed the full five years. TransCon PTH replicated endogenous PTH across kidney, intestine, CNS, and bone, with normalized urine and serum calcium, sustained bone mineral density, and quality-of-life gains. The data directly stress-tests MBX Biosciences's once-weekly canvuparatide Phase 2 readout from June 12, which posted 63% responder at 12 weeks and 57% at one year.
Crinetics Pharmaceuticals (Nasdaq: CRNX) will present an oral abstract Sunday June 14 (1:45-3:15 PM CT, Room W183BC) covering up to two years of efficacy and pooled safety data from the Palsonify (once-daily oral paltusotine) PATHFNDR-1 and PATHFNDR-2 open-label extensions in acromegaly, plus long-term combination data with cabergoline from the ACROBAT Advance trial. The presentation lands four days after Camurus's second Complete Response Letter on Oclaiz (CAM2029), the rival monthly subcutaneous octreotide depot, leaves the US acromegaly market with only one approved next-generation entrant (Palsonify, approved September 2025) through at least H1 2027. Crinetics will also present six total abstracts at ENDO including Phase 2 atumelnant data in congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome.