June 15, 2026

Entera EB613 Single-Tablet ENDO 2026 Matches Forteo, Rhythm Setmelanotide PWS + Hypothalamic Obesity + BBS, Crinetics Atumelnant Phase 2 CAH, Neurocrine Crenessity Pediatric 2-Year, 503B Window 14 Days

ENDO 2026 day 3: Entera EB613 single-tablet matches Forteo; Rhythm setmelanotide across PWS, AHO, BBS; Crinetics atumelnant CAH; Neurocrine Crenessity year 2.

5 stories · Covering clinical-trials, regulatory

Editor's Note

ENDO 2026 in Chicago entered its third day with four companies reporting fresh peptide-pathway endocrine data. Entera Bio's EB613, the oral PTH(1-34) tablet for postmenopausal osteoporosis, posted a comparative PK/PD profile matching Eli Lilly's injectable Forteo while keeping the patient-preferred convenience of a single daily oral tablet. Rhythm Pharmaceuticals brought setmelanotide updates across three rare-disease indications: a 2.5-year long-term extension in acquired hypothalamic obesity showing an 18.9% mean BMI reduction, interim Phase 2 data in Prader-Willi Syndrome showing 3.0-3.1% BMI reduction with lean-mass preservation across 17 patients, and real-world Bardet-Biedl Syndrome outcomes from the RESTORE study. Crinetics added full Phase 2 atumelnant results in congenital adrenal hyperplasia and an ACTH-dependent Cushing's syndrome interim, the company's once-daily oral ACTH receptor antagonist. Neurocrine Biosciences presented two-year CRENESSITY data in pediatric CAH plus the first retrospective case series in the 11β-hydroxylase subtype, the second-most-common form of classic CAH after 21-hydroxylase deficiency. The regulatory clock keeps moving: the FDA's 503B GLP-1 comment window closes June 29, 14 days from today.

Clinical Trials

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.

#entera-bio #eb613 #oral-peptide #teriparatide #forteo #osteoporosis #endo-2026 #n-tab-platform

Clinical Trials

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.

#rhythm-pharmaceuticals #setmelanotide #imcivree #mc4r #prader-willi-syndrome #hypothalamic-obesity #bardet-biedl-syndrome #endo-2026

Clinical Trials

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.

#crinetics #atumelnant #crn04894 #congenital-adrenal-hyperplasia #cushings-syndrome #acth-receptor-antagonist #endo-2026

Clinical Trials

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.

#neurocrine #crenessity #crinecerfont #crf1 #congenital-adrenal-hyperplasia #pediatric #endo-2026

Regulatory

FDA 503B GLP-1 Comment Window Two Weeks From Closure: June 29 Deadline Will End Large-Scale Compounding of Semaglutide, Tirzepatide, and Liraglutide

The FDA's April 30 proposed rule to permanently exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list enters its final two weeks of public comment on June 15. The 60-day comment window closes June 29, after which the agency will weigh comments and issue final rulemaking. Once finalized, the rule will prohibit 503B outsourcing facilities from bulk-compounding these GLP-1 molecules under any circumstance, including future shortage designation. The 503A pathway through licensed pharmacies remains intact ahead of the July 23-24 PCAC peptide-compounding advisory meeting, but the trajectory for large-scale GLP-1 compounding is fixed. Telehealth platforms (Hims & Hers, LifeMD, others) had already migrated to branded supply via Novo and Lilly partnerships since Q1 2026.

#fda #503b #compounding #semaglutide #tirzepatide #liraglutide #comment-window #rulemaking