This weekly Endocrinology update highlights key developments spanning regulatory metabolic disease milestones, device access expansion, clinical trial progress, and emerging AI-enabled insights. The news reflects continued convergence of therapeutics, diagnostics, and digital health in diabetes and bone disease.
In Today’s Newsletter
Dive deeper
🧪 Tzield Priority Review for youngest T1D cohort [1] [US • 07 Jan 2026]
Context: sBLA seeks to expand teplizumab to ages 1–7 with stage 2 T1D. PETITE-T1D interim year-1 data supports filing.
Key point: FDA accepted Priority Review, target decision 29 Apr 2026, to delay onset of stage 3 T1D.
Implication: May influence prescriber choice and payer reviews pending full data.
🏥 US pharmacy access expands for MiniMed 780G + new CGMs [2] [US • 07 Jan 2026]
Context: Agreements with major PBMs and PBM GPOs, including Ascent and Zinc. Includes Simplera, Simplera Sync, Instinct sensors.
Key point: Coverage expansion under pharmacy benefit aims to simplify access versus DME pathways.
Implication: May expand screening, initiation, and follow-up at scale.
🤖 Abbott debuts Libre Assist generative-AI meal guidance [3] [08 Jan 2026]
https://www.precedenceresearch.com/news/abbott-ai-diabetes-meal-decisions
Context: Tool integrated into Libre app, uses AI plus CGM data to estimate pre-meal glucose impact.
Key point: Users can input or photo meals to get color-coded predicted glycemic response.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.
🌞 Natural light stabilizes glucose in T2D crossover study [4] [07 Jan 2026]
Context: Controlled crossover, 13 older adults with T2D, natural vs artificial light, short duration.
Key point: Natural light exposure linked to more time in normal glucose range and less variability.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🦴 Angitia completes Phase 2 enrollment for AGA2118 in osteoporosis [5] [05 Jan 2026]
Context: ARTEMIS is randomized, double-blind, placebo-controlled, dose-ranging; n=379; primary lumbar spine BMD at 12 months.
Key point: Enrollment complete, topline expected in 2027.
Implication: May influence prescriber choice and payer reviews pending full data.
🧫 FDA qualifies BMD imaging surrogate for fracture risk [6] [US • 05 Jan 2026]
Context: Qualification of image-based BMD as surrogate endpoint followed analysis across 52 RCTs, 160k+ patients.
Key point: Enables smaller, faster osteoporosis trials using BMD changes in place of fracture outcomes.
Implication: Introduces competition that may affect pricing and formulary access.
🩸 Camurus’ Oclaiz gets US action date after resubmission [7] [US • 10 Jan 2026]
Context: Resubmitted NDA for monthly SC octreotide after prior CRL tied to third-party cGMP, not efficacy.
Key point: FDA set 10 Jun 2026 PDUFA; EU/UK approvals ongoing as Oczyesa.
Implication: Introduces competition that may affect pricing and formulary access.
👅 AI tongue imaging signals for diabetes and gastric cancer [8] [08 Jan 2026]
https://www.digitalhealthnews.com/ai-can-spot-diabetes-stomach-cancer-from-tongue-color-studies-show
Context: Review of 20+ studies; reports diagnostic performance for diabetes and gastric cancer from tongue photos.
Key point: AI detected disease-linked tongue features with notable accuracy across datasets, per sources cited.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧬 Genprex GPX-002 diabetes gene therapy program update [9] [07 Jan 2026]
Context: Preclinical T1D/T2D models, AAV delivery of Pdx1/MafA; tech transfer to CDMOs; FDA meeting requested.
Key point: In vivo proof-of-concept in animal models reported, with plans for IND-enabling work.
Implication: Signals pipeline investment and modality expansion.
🍽️ ADA notes new US Dietary Guidelines relevance to diabetes [10] [08 Jan 2026]
https://firstwordpharma.com/story/7048238
Context: Statement highlights guidance for chronic metabolic conditions and culturally responsive eating patterns.
Key point: ADA supports implementation to improve prevention and management for people with diabetes.
Implication: May expand screening, initiation, and follow-up at scale.
🔬 IL-6 regulates Dectin-1 macrophage behavior in thyroid cancer [11] [10 Jan 2026]
Context: Preclinical study explores IL-6 effects on Dectin-1 macrophage polarization and function in tumor immunity.
Key point: Identifies pathways by which IL-6 may modulate macrophage responses in thyroid cancer.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
Why it matters
- Pediatric T1D prevention window is shifting earlier, with potential care-path changes if Tzield expands.
- Pharmacy-channel pump and CGM access can reduce friction and costs compared with DME routes.
- AI-enabled nutrition guidance tied to CGM data reflects a move from reactive to predictive self-management.
- Qualified BMD surrogate may compress osteoporosis development timelines and revitalize investment.
- Resubmissions and platform advances in endocrine and bone underscore active regulatory and translational cycles.
🚀 Accelerate your success. Contact us now
📂 Explore our case studies. See examples of our work.
💡 Read our insights. Learn from our latest reports and analysis
🎬 Watch on YouTube. Subscribe and never miss a video.
🧰 See our full range of services. Discover how we can help you.
📚 View the full Endocrinology archive on our research hub page.
FAQ
What age expansion is Sanofi seeking for Tzield in the US?
Children 1–7 years with stage 2 T1D, aiming to delay progression to stage 3. FDA target action date is 29 Apr 2026 [1].
Which access channel is expanding for Medtronic’s MiniMed 780G in the US?
Pharmacy benefit coverage via PBM and GPO agreements, including Ascent and Zinc, covering pump and new CGMs [2].
What does Abbott’s Libre Assist do inside the Libre app?
It predicts the likely glycemic impact of a meal before eating using AI and CGM data, providing color-coded guidance [3].
How strong is the natural-light evidence in T2D?
It is a short, controlled crossover study in 13 older adults with T2D. Findings are directional, and real-world confirmation is needed [4].
What is Angitia testing in ARTEMIS, and what is the primary endpoint?
AGA2118, a sclerostin/DKK1 bispecific for osteoporosis. Primary endpoint is percent change in lumbar spine BMD at 12 months; n=379 [5].
How does FDA’s surrogate qualification affect osteoporosis trials?
It allows BMD changes to serve as a surrogate for fracture risk, enabling smaller and faster trials (details attributed to source) [6].
What is the US status of Camurus’ Oclaiz for acromegaly?
Resubmitted NDA accepted with a 10 Jun 2026 action date, following a prior CRL tied to cGMP issues, not efficacy [7].
Entities / Keywords
Sanofi, Tzield, teplizumab; Medtronic Diabetes, MiniMed 780G, Simplera, Simplera Sync, Instinct; Abbott, Libre, Libre Assist; University of Geneva, Maastricht University; Angitia Biopharmaceuticals, AGA2118, ARTEMIS; FDA, surrogate endpoint, bone mineral density; Camurus, Oclaiz, CAM2029, octreotide; AI tongue imaging; Genprex, GPX-002, Pdx1, MafA; IL-6, Dectin-1, thyroid cancer macrophages.
References
- https://www.indianpharmapost.com/drug-approval/fda-grants-priority-review-to-tzield-for-youngest-type-1-diabetes-patients-18788
- https://news.medtronic.com/2026-01-07-Medtronic-Diabetes-secures-U-S-pharmacy-formulary-access-for-MiniMed-TM-780G-System,-including-pump-and-new-CGMs
- https://www.precedenceresearch.com/news/abbott-ai-diabetes-meal-decisions
- https://www.news-medical.net/news/20260107/Study-shows-beneficial-impact-of-natural-light-on-people-with-type-2-diabetes.aspx
- https://www.globenewswire.com/news-release/2026/01/05/3212633/0/en/Angitia-Biopharmaceuticals-Completes-Enrollment-of-Phase-2-ARTEMIS-Trial-Evaluating-AGA2118-for-the-Treatment-of-Osteoporosis.html
- https://www.openaccessgovernment.org/new-breakthrough-could-bring-osteoporosis-treatments-to-patients-faster/203063/
- https://www.theglobeandmail.com/investing/markets/markets-news/Tipranks/36981937/camurus-acromegaly-drug-oclaiz-gains-fda-review-date-after-resubmitted-us-filing/
- https://www.digitalhealthnews.com/ai-can-spot-diabetes-stomach-cancer-from-tongue-color-studies-show
- https://www.prnewswire.com/news-releases/genprex-provides-clinical-update-on-diabetes-gene-therapy-program-302654680.html
- https://firstwordpharma.com/story/7048238
- https://www.geneonline.com/il-6-identified-as-a-regulator-of-dectin-1-macrophage-behavior-in-thyroid-cancer-immune-response/