Catch up on the latest endocrinology highlights—from major developments and new regulations to exciting progress across the biopharma industry.
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🧪 BMD qualified as surrogate endpoint for osteoporosis trials (US • 19 Dec 2025)
Context: FNIH Biomarkers Consortium SABRE analyses pooled more than one hundred sixty thousand participants across fifty-two clinical trials.
Key point: FDA qualified treatment-related change in hip bone mineral density as a surrogate endpoint for fracture outcomes in post-menopausal osteoporosis trials.
Implication: May influence prescriber choice and payer reviews pending full data.
📣 Medtronic’s “Own It” campaign for MiniMed 780G + Abbott Instinct (18 Dec 2025)
Context: FDA-cleared combination of MiniMed 780G and Abbott Instinct for type one diabetes, with U.S. rollout beginning in early December.
Key point: Campaign highlights automated insulin dosing via SmartGuard to reduce daily management burden.
Implication: Direct-to-consumer and telehealth models could streamline initiation and adherence.
🐱 Virbac acquires Felanorm / Thyronorm methimazole oral solution (~€100M) (18 Dec 2025)
https://www.dvm360.com/view/ownership-of-feline-hyperthyroidism-drug-shifts-in-100-million-deal
Context: First FDA-approved generic methimazole oral solution for feline hyperthyroidism, with global brand variants.
Key point: Virbac acquires the asset from Norbrook, with distribution transitioning by region.
Implication: Introduces competition that may affect pricing and formulary access.
🏭 Sony UK Technology Centre to manufacture Afon’s non-invasive Glucowear (UK • 18 Dec 2025)
Context: Commercial profile announcing contract manufacturing for RF and microwave-based non-invasive continuous glucose monitoring.
Key point: Partnership aims to scale Glucowear toward near-term UK commercialization.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.
🇨🇳 Mazdutide Phase 3 results published in Nature (China • 19 Dec 2025)
https://global.chinadaily.com.cn/a/202512/19/WS6944f6a6a310d6866eb2f856.html
Context: DREAMS-1 and DREAMS-2 Phase 3 trials in type two diabetes; dual GCG/GLP-1 agonist developed by Innovent.
Key point: Trials met primary endpoints for glycemic control and weight loss versus placebo and dulaglutide.
Implication: May influence prescriber choice and payer reviews pending full data.
👶 Real-time CGM lowers LGA in gestational diabetes (GRACE RCT, 19 Dec 2025)
https://www.endocrinologyadvisor.com/news/rt-cgm-reduces-lga-gestational-diabetes/
Context: Open-label randomized controlled trial with three hundred seventy-five participants comparing rt-CGM with SMBG.
Key point: Lower large-for-gestational-age rates and reduced birthweight percentiles with rt-CGM.
Implication: Could inform clinical practice and payer discussions.
🧬 Immutep IMP761 Phase 1 SAD shows dose-dependent immunosuppression (22 Dec 2025)
Context: LAG-3 agonist antibody evaluated in healthy volunteers across two dose cohorts.
Key point: Tolerated with mild adverse events and dose-dependent immunosuppressive signals.
Implication: Signals pipeline expansion and partnership potential.
💊 Entera Bio EB612 oral long-acting PTH analog shows preclinical durability (22 Dec 2025)
Context: Minipig study using N-Tab platform following earlier Phase 2 program.
Key point: Single oral dose achieved prolonged exposure and sustained calcium elevation.
Implication: May alter future hypoparathyroidism treatment paradigms.
🦴 Celltrion launches denosumab biosimilars Stoboclo and Osenbelt in Europe (22 Dec 2025)
https://biz.chosun.com/en/en-science/2025/12/22/2Q7M42ZBPVBUFFKG76ZHP5FDMA/?outputType=amp
Context: Biosimilars to Prolia and Xgeva launched across Germany, Spain, France, and Portugal.
Key point: Sequential European expansion planned.
Implication: Increased price competition in osteoporosis and oncology bone care.
🔎 Bisphosphonates and renal function in elderly osteoporosis (24 Dec 2025)
Context: Preview of an upcoming BMC Geriatrics study.
Key point: Analysis explores kidney function impact in older adults.
Implication: Interpretation depends on study design and confounding control.
🧷 Diamyd DIAGNODE-3 primary readout moved to fifteen months (29 Dec 2025)
Context: Phase 3 trial in HLA DR3-DQ2 stage three type one diabetes.
Key point: Primary efficacy timepoint shortened to fifteen months.
Implication: Accelerates potential regulatory decision-making.
😴 CPAP linked to survival benefit in T2D with OSA (04 Jan 2026)
Context: Conference-presented long-term outcomes in patients with type two diabetes and obstructive sleep apnea.
Key point: CPAP use associated with reduced major events and mortality.
Implication: May support payer and guideline discussions.
❌ FDA issues CRL for relacorilant in Cushing’s-related hypertension (US • 02 Jan 2026)
https://cushingsdiseasenews.com/news/fda-rejects-relacorilant-cushings-related-high-blood-pressure/
Context: Application supported by GRACE and GRADIENT trials.
Key point: FDA concluded benefit-risk was not yet favorable.
Implication: Additional evidence required.
💸 Ultragenyx setrusumab fails late-phase OI fracture trials (02 Jan 2026)
Context: ORBIT and COSMIC Phase 3 trials in osteogenesis imperfecta.
Key point: Fracture endpoints missed despite BMD improvements.
Implication: Program reassessment and cost reductions planned.
Why it matters
- FDA recognition of hip BMD as a surrogate endpoint may shorten osteoporosis drug development timelines.
- Denosumab biosimilars increase pricing pressure across bone health indications.
- New metabolic drugs and devices signal modality expansion in diabetes.
- Adjunctive tools such as rt-CGM and CPAP may improve outcomes.
- Regulatory paths diverge across therapeutic areas.
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FAQ
What exactly did FDA qualify in osteoporosis trials?
The FDA qualified treatment-related change in hip bone mineral density as a surrogate for fracture outcomes in post-menopausal osteoporosis trials, based on FNIH SABRE data.
How is Diamyd’s Phase 3 timeline changing?
The DIAGNODE-3 primary readout moves from twenty-four to fifteen months after FDA alignment, with the twenty-four-month durability assessment retained as a secondary endpoint.
Which denosumab biosimilars just launched in Europe?
Celltrion’s Stoboclo and Osenbelt, and Samsung Bioepis’ Obodence and Xbryk, launched in key European Union markets, referencing Prolia and Xgeva.
What do Nature’s mazdutide papers show?
Phase 3 DREAMS-1 and DREAMS-2 trials in Chinese patients with type two diabetes met primary glycemic control and weight loss endpoints with consistent safety, as summarized by China Daily.
Why did relacorilant receive a CRL?
The FDA stated that the benefit-risk profile was not yet conclusively favorable despite the GRACE trial meeting its main goal, and requested additional evidence per Corcept.
Did setrusumab reduce fractures in osteogenesis imperfecta?
No. Two late-phase trials missed fracture primary endpoints despite improvements in bone mineral density, and Ultragenyx plans significant cost reductions and further analysis.
Entities / Keywords
FNIH Biomarkers Consortium; FDA Biomarker Qualification; hip bone mineral density; DEXA •
Medtronic MiniMed 780G; Abbott Instinct; SmartGuard •
Virbac; Felanorm; Thyronorm; methimazole •
Afon Technology Glucowear; Sony UK Technology Centre; non-invasive continuous glucose monitoring •
Innovent Biologics; mazdutide; GLP-1 and GCG dual agonist •
GRACE randomized controlled trial; gestational diabetes; real-time CGM; large-for-gestational-age •
Immutep IMP761; LAG-3 agonist •
Entera Bio EB612; oral long-acting parathyroid hormone; hypoparathyroidism •
Celltrion Stoboclo and Osenbelt; denosumab biosimilars •
Samsung Bioepis Obodence and Xbryk; European market access •
CPAP; type two diabetes; obstructive sleep apnea •
Corcept relacorilant; Cushing’s syndrome •
Ultragenyx setrusumab; osteogenesis imperfecta
References
https://www.dvm360.com/view/ownership-of-feline-hyperthyroidism-drug-shifts-in-100-million-deal
https://global.chinadaily.com.cn/a/202512/19/WS6944f6a6a310d6866eb2f856.html
https://www.endocrinologyadvisor.com/news/rt-cgm-reduces-lga-gestational-diabetes/
https://biz.chosun.com/en/en-science/2025/12/22/2Q7M42ZBPVBUFFKG76ZHP5FDMA/?outputType=amp
https://cushingsdiseasenews.com/news/fda-rejects-relacorilant-cushings-related-high-blood-pressure/