This Endocrinology video recap covers regulatory advances, biosimilar market expansion, novel delivery modalities, and emerging digital and AI-enabled tools across endocrinology. Developments span osteoporosis, diabetes, hypoparathyroidism, and metabolic disease, with implications for trial design, access, and competition.
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Top Stories Covered in This Video
Chapters
0:00 Introduction
0:08 FDA qualifies hip BMD change as surrogate endpoint for fracture risk in postmenopausal osteoporosis trials, US 0:42 Entera Bio advances oral long-acting PTH EB612 for hypoparathyroidism with single-dose multiday exposure
1:16 Celltrion launches denosumab biosimilars Stoboclo and Osenbelt across key EU markets for osteoporosis and oncology SREs
1:38 Samsung Bioepis rolls out Obodence and Xbryk denosumab biosimilars across Europe with RWE and supply focus 2:02 AI tongue imaging shows diagnostic signals for diabetes and gastric cancer across multi-study evidence
2:25 Genprex GPX-002 diabetes gene therapy program details IND-enabling plans and manufacturing scale-up
2:56 FDA Priority Review for Tzield sBLA to include ages 1–7 with stage 2 type 1 diabetes, target action in the US
3:18 Medtronic secures US pharmacy formulary access for MiniMed 780G and new CGMs via PBM agreements
3:50 How to reach us
Transcript
Welcome to the latest edition of Endocrinology Updates, covering recent breakthroughs in the field. Brought to you by LucidQuest, this update highlights:
The FDA has qualified treatment-related change in hip bone mineral density as a surrogate endpoint for fracture risk in postmenopausal women at risk, announced 19 Dec 2026. This decision draws on the Fnih Biomarkers Consortium Sabre project, which pooled 52 trials with more than 160,000 participants. Expect shorter osteoporosis trials and a spark in investment, with new competitors influencing pricing and formulary access.
Entera Bio reports progress on EB612 for hypoparathyroidism, advancing an oral long-acting PTH tablet. In preclinical minipig studies using the N-Tab platform, the lead analog produced multi-day exposure and raised calcium from a single oral dose, supporting a once-daily goal. Earlier Phase 2 used unmodified PTH(1-34) dosed four times daily. This signals pipeline commitment and modality expansion.
Celltrion has launched Stoboclo and Osenbelt in Germany, Spain, France, and Portugal, targeting osteoporosis and oncology skeletal-related events, with country-specific strategies across hospital and retail channels. Competitive pressure is likely to shape price and access across the EU.
Samsung Bioepis is rolling out Obodence, referencing Prolia, and Xbryk, referencing Xgeva, with an emphasis on supply continuity and real-world evidence across more than 19 markets. This broad entry is designed to accelerate adoption and intensify competition on pricing and formulary placement.
Reports on AI tongue imaging synthesize more than 20 studies, including datasets from 2024 and 2023, suggesting adjunctive utility for diabetes and gastric cancer screening. Performance varies by study design and control of confounders, so clinical integration should proceed with careful validation.
Genprex outlined progress on GPX-002, an AAV program delivering Pdx1 and MafA with proof of concept in type 1 and type 2 diabetes animal models, tech transfer to CDMOs, and a requested FDA meeting, plus exploration of a second-generation LNP approach. This points to ongoing manufacturing scale-up and modality expansion.
The FDA has granted Priority Review for Tzield to include children ages 1 to 7 with stage 2 type 1 diabetes, aiming to delay progression to stage 3, with a target action date of 29 Apr 2026. Pending full data, this could influence prescriber choice and payer reviews.
Medtronic has expanded pharmacy-benefit coverage for the MiniMed 780G automated insulin delivery system and new CGMs, including Simplera, Simplera Sync, and Instinct, through agreements with PBMs and PBM GPOs such as Ascent and Zinc. Pharmacy-channel coverage can reduce upfront costs, align pumps, sensors, and consumables, and streamline prescribing compared with DME pathways.
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Why it matters
- Surrogate endpoint qualification can shorten osteoporosis trials and catalyze investment.
- Oral peptide replacement programs could shift rare endocrine care away from injections.
- EU denosumab biosimilars introduce near-term price competition across osteoporosis and oncology SRE markets.
- Pediatric T1D prevention may move earlier if Tzield’s label expands.
- Pharmacy-channel access can reduce friction for automated insulin delivery adoption.
- Emerging AI signals in diagnostics and nutrition need careful validation but may scale quickly once integrated into workflows.
FAQ
What exactly did FDA qualify for osteoporosis trials?
Treatment-related change in hip BMD as a surrogate endpoint for fracture in postmenopausal women at risk, based on SABRE data pooled across 52 trials [1].
How is Entera Bio’s EB612 different from current PTH options?
It targets a once-daily oral tablet using a long-acting PTH analog and oral delivery platform, whereas current PTH replacement requires injections; current data are preclinical for the long-acting analog [2].
Where are denosumab biosimilars launching in Europe?
Celltrion reported launches in Germany, Spain, France, and Portugal, with broader EU rollout planned; Samsung Bioepis is also launching Obodence/Xbryk across multiple EU markets [3][4].
What is Sanofi seeking for Tzield in the US?
Priority Review of an sBLA to include children 1–7 years with stage 2 T1D to delay progression to stage 3; FDA target action 29 Apr 2026 [7].
How will Medtronic’s PBM deals change access?
By expanding pharmacy-benefit coverage for MiniMed 780G and associated CGMs, potentially lowering upfront costs and simplifying prescribing versus DME channels [8].
Is AI tongue analysis ready for clinical diagnosis?
Sources report promising accuracy across multiple studies, but performance depends on datasets and conditions; it should be considered adjunctive pending broader validation [5].
Entities / Keywords
FNIH Biomarkers Consortium; FDA Biomarker Qualification Program; hip BMD surrogate; Entera Bio, EB612, PTH analog, N-Tab; Celltrion, Stoboclo, Osenbelt, denosumab biosimilar; Samsung Bioepis, Obodence, Xbryk; Sanofi, Tzield, teplizumab; Medtronic Diabetes, MiniMed 780G, Simplera, Simplera Sync, Instinct; GPX-002, Pdx1, MafA, Genprex; AI tongue imaging, diabetes, gastric cancer.
References
https://biz.chosun.com/en/en-science/2025/12/22/2Q7M42ZBPVBUFFKG76ZHP5FDMA/?outputType=amp
https://www.digitalhealthnews.com/ai-can-spot-diabetes-stomach-cancer-from-tongue-color-studies-show