Peptide News Digest

Clinical Trials News

276 stories across all digests

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.

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Recordati ISTURISA (Osilodrostat) LINC Program ENDO 2026 Data: Four Cushing's Syndrome Poster Presentations on Biochemical Control, Patient-Reported Quality of Life, and Real-World Outcomes

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).

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Hanmi Pharmaceutical Unveils HM500197 (LA-MSTN) at ADA 2026 as the World's First Peptide-Based Myostatin Inhibitor for GLP-1 Muscle-Loss Adjunct Use

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.

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Medscape (June 16): Tirzepatide Reverses Postbariatric Weight Regain in University of Catania Study

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.

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Entera Bio EB613 Single-Tablet ENDO 2026 Oral Presentation: Comparative PK/PD Matches Forteo, 14 of 15 Patients Prefer Single Tablet Over Multi-Tablet, All 15 Prefer Oral Over Injection

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.

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Rhythm Pharmaceuticals Presents Setmelanotide ENDO 2026 Data Across Three Rare-Disease Indications: Acquired Hypothalamic Obesity 2.5-Year LTE, Prader-Willi Syndrome Phase 2 Interim, and Bardet-Biedl Syndrome Real-World

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.

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Crinetics Presents Full Phase 2 Atumelnant Results in Congenital Adrenal Hyperplasia and Interim ACTH-Dependent Cushing's Data at ENDO 2026

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.

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Neurocrine CRENESSITY (Crinecerfont) Two-Year Pediatric CAH Data at ENDO 2026 Plus First Retrospective Case Series in 11β-Hydroxylase Subtype

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.

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Crinetics Presents 2-Year Palsonify (Paltusotine) Open-Label Extension Data at ENDO 2026, Confirms Durable Acromegaly Control

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.

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Ascendis TransCon CNP (YUVIWEL, Navepegritide) 2-Year ApproaCH Data: Sustained Growth Velocity in Children 5+ With Achondroplasia at ENDO 2026

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.

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Ascendis Pharma 5-Year TransCon PTH PaTH Forward Data: 82% Off Active Vitamin D and Calcium at Week 266, 95% Trial Completion

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.

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Crinetics Palsonify (Paltusotine) Up to 2-Year PATHFNDR-1 and PATHFNDR-2 Open-Label Extension Data at ENDO 2026 on June 14

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.

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Entera Bio EB613 Oral PTH(1-34) Single-Tablet Data Selected for ENDO 2026 Late-Breaking Oral Presentation, EB618 Oral GLP-1/Glucagon NHP PK/PD Saturday

Entera Bio (Nasdaq: ENTX) confirmed that its first-in-class oral PTH(1-34) tablet EB613 was selected for a late-breaking oral presentation at ENDO 2026 covering single-tablet data ahead of the 750-patient Phase 3 trial set to start late 2026 in postmenopausal osteoporosis. EB613 applies Entera's N-Tab oral-peptide delivery platform to teriparatide (the active ingredient in Forteo). On the obesity side, Entera will present preclinical PK/PD data on EB618, a first-in-class oral dual GLP-1/glucagon receptor agonist, in non-human primates on Saturday June 13 12:15-1:45 PM CT. The ENDO slot extends Entera's spring narrative beyond the Q1 2026 Phase 3 plan first disclosed in May.

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Protagonist and Takeda Bring Phase 3 VERIFY and Long-Term Rusfertide Data to EHA 2026 in Stockholm Through June 14

Protagonist Therapeutics (Nasdaq: PTGX) and Takeda are presenting four rusfertide abstracts at the 2026 European Hematology Association Congress in Stockholm (June 11-14), including analyses from the Phase 3 VERIFY study and long-term results from the Phase 2 REVIVE and THRIVE open-label extensions. The 32-week VERIFY primary analysis showed 76.9% of patients on rusfertide achieved a clinical response versus 32.9% on placebo; the 52-week dataset met the primary endpoint and all four key secondary endpoints. Rusfertide is a first-in-class subcutaneous hepcidin-mimetic peptide for polycythemia vera. The FDA accepted the rusfertide NDA in early 2026 with priority review and set a Q3 2026 PDUFA target action date.

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MBX Biosciences Canvuparatide Hits 63% Responder Rate in Phase 2 Avail, Sustains Through One-Year Open-Label Extension, Phase 3 Set for Q3 2026

MBX Biosciences (Nasdaq: MBX) on June 12 reported full 12-week Phase 2 Avail data and one-year open-label extension results for once-weekly canvuparatide, a precision PTH peptide for chronic hypoparathyroidism. The trial hit its primary endpoint with a 63% responder rate versus 31% on placebo at 12 weeks; the OLE delivered a 79% responder rate at six months and 57% at one year. Patients showed normalized serum calcium, reduced urine calcium excretion, restored bone metabolism, and improved eGFR; 90% of OLE patients remained on study at one year with no new safety signals. A registrational Phase 3 in chronic hypoparathyroidism starts Q3 2026.

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Novartis Del-Brax FORTITUDE Phase 1/2 Biomarker Cohort Meets Primary Endpoint in Facioscapulohumeral Muscular Dystrophy

Novartis (which acquired Avidity Biosciences in February 2026) announced June 11 that the biomarker cohort of the Phase 1/2 FORTITUDE trial of delpacibart braxlosiran (del-brax, AOC 1020) met its primary and key secondary endpoints, with reductions in KHDC1L (cDUX target) and creatine kinase indicating strong target engagement and reduced muscle damage in adults with FSHD. The data validate the dosing regimen now being used in the Phase 3 FORWARD trial enrolling 200 patients across the US and Europe. Del-brax is an antibody-oligonucleotide conjugate aimed at aberrant DUX4 expression, the same conjugate-modality family as the peptide-oligonucleotide conjugates from PepGen (PGN-EDODM1 for DM1) and Vertex (VX-670).

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Pfizer Berobenatide VESPER-1 Phase 2b at ADA 2026: 15.9% Weight Loss at 32 Weeks With No Plateau, Monthly Dosing Profile

Pfizer presented Phase 2b VESPER-1 data for berobenatide (PF-07976094 / PF'3944), the ultra-long-acting injectable GLP-1 peptide engineered for monthly dosing through a 0.5 mL low-volume injection. At ADA 2026, the 2.4 mg weekly dose drove up to 15.9% mean weight loss at 32 weeks with no plateau across the VESPER program, plus improved glycemic control and favorable tolerability. Pfizer plans more than 20 obesity-related trials in 2026, including 10 Phase 3 studies of berobenatide in chronic weight management, knee osteoarthritis, and obstructive sleep apnea. The asset entered Pfizer's pipeline through the $4.9 billion Metsera acquisition.

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Retatrutide Dysesthesia Safety Signal Sharpens at ADA 2026: 20.9% at 12 mg Versus 8.8% at 9 mg and 0.7% on Placebo

The full TRIUMPH-1 safety dataset clarified the retatrutide dysesthesia signal: 20.9% of patients on 12 mg reported tingling, tenderness, or altered sensation, versus 8.8% at 9 mg and 0.7% on placebo. The signal is dose-dependent, generally mild to moderate, and Lilly says it is being monitored across all ongoing TRIUMPH trials. The data sit alongside the arrhythmia signal (7/403 retatrutide, 3 MACE versus 0 placebo) that STAT flagged on June 6 and now constitute the field's main retatrutide-specific safety conversation.

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Lilly Foundayo (Orforglipron) ACHIEVE Phase 3 Data at ADA: Head-to-Head Win Over Oral Semaglutide, FDA Filing in Q2

Lilly presented full Phase 3 data from the ACHIEVE program in type 2 diabetes at ADA 2026's Monday symposium. In the head-to-head ACHIEVE-3 trial, Foundayo (orforglipron) beat oral semaglutide across the primary and all key secondary endpoints, with 37.1% of patients on the highest Foundayo dose reaching HbA1c under 5.7% (normal range) versus 12.5% on the highest oral semaglutide dose tested. ACHIEVE-2 compared Foundayo to dapagliflozin; ACHIEVE-5 added it to insulin glargine. Lilly plans to submit Foundayo for FDA T2D approval by end of Q2 under the Commissioner's National Priority Voucher.