Endocrinology Today — October 28, 2025

LucidQuest

2 weeks ago

Endocrinology news this week covers major developments, updates, launches and progress across the biopharma sector.

In Today’s Newsletter

🦴 Sōlaria Biō launches Bondia medical food for bone health [1] [US • 20 Oct 2025]

https://www.biospace.com/press-releases/solaria-bio-announces-new-bone-health-breakthrough-with-bondia
Context: Press release notes RCT in Osteoporosis International, 286 postmenopausal women with osteopenia or BMI ≥30.
Key point: Company reports Bondia slowed bone loss vs placebo, including an osteopenia subgroup claim of 85% femoral-neck bone-loss reduction (endpoint details not specified).
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

❤️ Rybelsus label adds CV risk-reduction in T2D after SOUL 🎯 [2] [US • 21 Oct 2025]

https://www.zacks.com/stock/news/2773041/nvos-rybelsus-gets-fda-nod-to-reduce-heart-risk-in-diabetes-patients
Context: SOUL Phase IIIb reported 14% relative MACE risk reduction vs placebo; safety consistent with class with higher GI AEs.
Key point: FDA approved oral semaglutide to reduce MACE in high-risk adults with T2D, expanding Rybelsus’ US label.
Implication: May influence prescriber choice and payer reviews pending full data.

💊 Entera Bio’s EB613 oral PTH shows BMD gains in early postmenopause [3] [IL • 23 Oct 2025]

https://www.globenewswire.com/news-release/2025/10/23/3172057/0/en/Entera-Bio-Presents-Positive-New-Clinical-Data-from-EB613-Phase-2-Trial-Demonstrating-Significant-Bone-Density-Improvements-in-Early-Postmenopausal-Women.html
Context: Post-hoc analysis of Phase 2 RCT, 6 months; subgroup n reported as EB613 n=8 vs placebo n=19.
Key point: 2.5 mg EB613 increased BMD vs placebo at lumbar spine (+3.1%), total hip (+2.3%), femoral neck (+2.0%).
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Tzield sBLA expedited to delay progression in stage 3 T1D [4] [US • 21 Oct 2025]

https://www.managedhealthcareexecutive.com/view/type-1-diabetes-drug-tzield-under-expedited-review-through-new-fda-program
Context: PROTECT Phase 3 in recent-onset 8–17 years preserved C-peptide; key secondaries not statistically significant; CRS ~1.8%.
Key point: FDA accepted sBLA under National Priority Voucher pilot and accelerated approval pathway for stage 3 T1D.
Implication: May influence prescriber choice and payer reviews pending full data.

🇮🇳 Lilly–Cipla introduce tirzepatide as Yurpeak in India 💉 [5] [IN • 24 Oct 2025]

https://www.business-standard.com/industry/news/lilly-cipla-yurpeak-tirzepatide-launch-india-diabetes-obesity-125102301152_1.html
Context: Cipla to distribute and promote; Lilly to manufacture; KwikPen 2.5–15 mg; pricing aligned with Mounjaro.
Key point: Collaboration targets expanded access across urban and semi-urban markets without price change.
Implication: Introduces competition that may affect pricing and formulary access.

⚡ Neurotronic to unveil first outcomes of multi-organ denervation in T2D + HTN [6] [US • 24 Oct 2025]

https://finance.yahoo.com/news/neurotronic-announces-first-clinical-outcomes-120000904.html
Context: NECTAR III–IV single-arm studies of hepatic and bilateral renal ethanol denervation; results to be presented at TCT 2025.
Key point: First reported clinical outcomes for Neuviant MDN in uncontrolled T2D and HTN, with details pending presentations.
Implication: Signals pipeline investment and modality expansion.

🔊 Ultrasound-stimulated microbubbles may enhance lenvatinib in thyroid cancer [7] [25 Oct 2025]

https://bioengineer.org/ultrasound-boosts-lenvatinibs-effects-on-thyroid-cancer/
Context: Summary of research in BMC Pharmacology and Toxicology on ultrasound-activated microbubble cavitation with lenvatinib.
Key point: In vitro and animal models reportedly showed augmented antitumor effects without added toxicity per article (study design specifics not detailed).
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧬 LAMB3 expression linked to aggressiveness in papillary thyroid carcinoma [8] [25 Oct 2025]

https://www.geneonline.com/lamb3-expression-linked-to-increased-malignancy-in-papillary-thyroid-carcinoma/
Context: Report highlights associations between elevated LAMB3 and malignant or metastatic behavior in PTC.
Key point: Higher LAMB3 expression associated directionally with increased malignancy, with calls for further mechanistic study.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

Why it matters

Oral and noninvasive modalities may improve initiation and adherence versus injectables in osteoporosis and metabolic disease.
Rybelsus’ CV label broadens GLP-1 utility across cardiometabolic risk management.
Expedited FDA pathways can compress timelines for high-need indications such as stage 3 T1D.
India distribution partnerships can expand reach and shape pricing dynamics for obesity and diabetes therapies.

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FAQ

What evidence underpins Bondia’s claims?

A company-described RCT in Osteoporosis International with 286 postmenopausal women reported slowed bone loss vs placebo and an osteopenia subgroup claim of 85% femoral-neck benefit, with limited endpoint detail in the release [1].

What exactly changed on Rybelsus’ US label?

FDA added an indication to reduce major adverse cardiovascular events in high-risk adults with T2D, supported by the SOUL trial’s 14% relative MACE reduction vs placebo [2].

How robust are EB613’s data for Phase 3 planning?

A post-hoc Phase 2 analysis showed 6-month BMD gains at spine, hip and femoral neck at the 2.5 mg dose in early postmenopause, complementing prior results and supporting dose selection [3].

What is the scope of Tzield’s new filing?

An sBLA seeks to delay progression in stage 3 T1D, accepted under an expedited pilot and accelerated approval, with PROTECT preserving C-peptide though key secondaries were not significant [4].

How will Yurpeak change tirzepatide access in India?

Cipla will distribute and promote a second brand at parity pricing to Mounjaro, aiming to extend access beyond metros using its network [5].

What is known about Neurotronic’s denervation outcomes?

NECTAR III–IV are single-arm studies of hepatic and renal ethanol denervation in uncontrolled T2D and HTN; first outcome data are being presented at TCT 2025, with specifics not in the release [6].

Entities / Keywords

Sōlaria Biō; Bondia; synbiotic medical food; osteopenia; Osteoporosis International.
Novo Nordisk; Rybelsus; oral semaglutide; SOUL; MACE.
Entera Bio; EB613; oral PTH(1-34); BMD; NAMS 2025.
Sanofi; Tzield; teplizumab; PROTECT; National Priority Voucher.
Eli Lilly; Cipla; tirzepatide; Yurpeak; Mounjaro; India access.
Neurotronic; Neuviant; NECTAR III–IV; TCT 2025.
Lenvatinib; ultrasound microbubbles; anaplastic thyroid cancer.
LAMB3; papillary thyroid carcinoma; PTC malignancy.