This week’s Endocrinology update highlights regulatory progress, advancing clinical research, biosimilar launches, safety observations, and diagnostic innovation across diabetes, osteoporosis, and thyroid disease.
In Today’s Newsletter
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🧬 LyGenesis immune tolerance award [1] [US • 25 Jun 2026]
https://www.prnewswire.com/news-releases/lygenesis-receives-award-from-breakthrough-t1d-to-fund-a-research-project-to-induce-immune-tolerance-to-pancreatic-islet-transplantation-302810495.html
Context: LyGenesis (cell therapy platform) received a Breakthrough T1D award for Dr. Eric Lagasse’s thymus program.
Key point: The project supports pre-clinical work to induce immune tolerance after allogeneic pancreatic islet transplantation in Type 1 diabetes.
Implication: Signals pipeline investment and modality expansion.
🩺 Phathom completes VOQUEZNA EoE enrollment [2] [US • 23 Jun 2026]
https://firstwordpharma.com/story/7643148
Context: Phathom enrolled 95 adults at 41 US sites in the randomized, double-blind, placebo-controlled Phase 2 pHalcon-EoE-201 trial.
Key point: VOQUEZNA (vonoprazan) 20 mg once daily is being studied versus placebo for 12 weeks in eosinophilic esophagitis.
Implication: May influence prescriber choice and payer reviews pending full data.
👃 GLP-1s linked to smell and taste impairment [3] [26 Jun 2026]
https://www.reuters.com/business/healthcare-pharmaceuticals/glp-1s-linked-smell-taste-impairment-diabetes-patients-2026-06-26/
Context: Reuters reported an electronic health record analysis of nearly 900,000 Type 2 diabetes patients from 2017–2026.
Key point: Long-term GLP-1 use was associated with higher smell and taste disturbance risk, though absolute rates were low.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧪 Testosterone and Type 2 diabetes risk in men [4] [AU • 26 Jun 2026]
https://www.endocrinologyadvisor.com/news/testosterone-levels-incident-type-2-diabetes-risk-men/
Context: Investigators analyzed MAILES study data from 1,299 men aged 35–80 without Type 2 diabetes, cancer, or testosterone treatment use.
Key point: Higher baseline testosterone was associated with lower 5-year incident Type 2 diabetes risk, with weaker association at older ages.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
💊 Lilly opens pediatric oral GLP-1 study [5] [26 Jun 2026]
https://www.theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/3003217/lilly-targets-youth-diabetes-with-new-oral-glp-1-trial-expanding-its-glp-1-footprint/
Context: Eli Lilly listed a Phase 3, randomized, open-label study in patients aged 10 to under 18 with Type 2 diabetes.
Key point: The trial will compare once-daily oral orforglipron with once-weekly dulaglutide for glycemic control, safety, and pharmacokinetics.
Implication: Signals pipeline investment and modality expansion.
🦴 Organon and Henlius launch denosumab biosimilars [6] [CA • 23 Jun 2026]
https://www.organon.com/canada-en/
Context: Organon Canada and Shanghai Henlius Biotech launched BILDYOS (denosumab 60 mg/1 mL) and TUZEMTY (denosumab 120 mg/1.7 mL).
Key point: The products are biosimilars to PROLIA and XGEVA and are available in Canada for all reference-product indications.
Implication: Introduces competition that may affect pricing and formulary access.
📋 Entera Bio gets FDA feedback on EB613 Phase 3 [7] [US • 23 Jun 2026]
https://www.globenewswire.com/news-release/2026/06/23/3315992/0/en/positive-fda-feedback-on-phase-3-brings-entera-bio-s-oral-osteoporosis-pill-one-step-closer-to-market.html
Context: Entera Bio’s EB613 is an oral PTH(1-34) tablet in development for postmenopausal osteoporosis.
Key point: FDA feedback supported a single randomized, double-blind, placebo-controlled Phase 3 study of about 750 women, using 12-month total hip BMD as the primary endpoint.
Implication: May influence prescriber choice and payer reviews pending full data.
🔬 Light-based imaging for thyroid cancer diagnosis [8] [US • 25 Jun 2026]
https://medicalxpress.com/news/2026-06-based-imaging-thyroid-cancer-diagnosis.html
Context: Houston Methodist researchers reported second harmonic generation microscopy findings in the Journal of Biomedical Optics.
Key point: The light-based method evaluates collagen signatures that may help distinguish papillary thyroid cancer from benign thyroid tissue.
Implication: Access programs may expand screening, initiation, and follow-up at scale.
Why it matters
- Oral peptide and GLP-1 development is expanding across diabetes, obesity, osteoporosis, and pediatric populations.
- Biosimilar launches in Canada may increase treatment options for osteoporosis and oncology-related bone indications.
- Observational safety signals around GLP-1 therapies underscore the need for monitoring as use broadens.
- Diagnostics innovation in thyroid cancer could reduce unnecessary surgery if larger validation studies support performance.
- Several updates are pre-approval or pre-clinical, so clinical and regulatory impact depends on future data.
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FAQ
What is LyGenesis studying with Breakthrough T1D funding?
LyGenesis is supporting pre-clinical research into immune tolerance after allogeneic pancreatic islet transplantation in Type 1 diabetes. The work is tied to Dr. Eric Lagasse’s thymus program. [1]
What is VOQUEZNA being tested for in Phathom’s pHalcon-EoE-201 trial?
VOQUEZNA (vonoprazan) is being studied as an investigational oral, non-steroidal treatment for eosinophilic esophagitis in adults. The 12-week double-blind portion has completed enrollment. [2]
What did the Reuters GLP-1 report find?
Reuters reported an EHR-based observational analysis linking long-term GLP-1 use in Type 2 diabetes with higher smell and taste disturbance risk. Absolute event rates were low. [3]
What is Lilly comparing oral orforglipron against?
Eli Lilly’s Phase 3 pediatric Type 2 diabetes study compares once-daily oral orforglipron with once-weekly dulaglutide. The trial is open-label and focused on efficacy, safety, and pharmacokinetics. [5]
Which denosumab biosimilars launched in Canada?
Organon Canada and Henlius launched BILDYOS, a biosimilar to PROLIA, and TUZEMTY, a biosimilar to XGEVA. Both are available for all reference-product indications in Canada. [6]
What did FDA feedback mean for Entera Bio’s EB613?
Entera Bio said FDA feedback supported its registrational Phase 3 protocol for EB613 in postmenopausal osteoporosis. The proposed study uses total hip bone mineral density at 12 months as the primary endpoint. [7]
Entities / Keywords
LyGenesis: thymus program, Dr. Eric Lagasse, Breakthrough T1D, pancreatic islet transplantation, Type 1 diabetes, immune tolerance
Phathom Pharmaceuticals: VOQUEZNA, vonoprazan, pHalcon-EoE-201, eosinophilic esophagitis, EoE, PCAB
GLP-1 therapies: semaglutide, diabetes, smell disturbance, taste disturbance, EHR analysis, JAMA Otolaryngology
MAILES study: testosterone, incident Type 2 diabetes, men, Southern Adelaide Diabetes and Endocrine Service
Eli Lilly: orforglipron, LY3502970, dulaglutide, LY2189265, pediatric Type 2 diabetes, oral GLP-1
Organon Canada, Henlius: BILDYOS, TUZEMTY, denosumab, PROLIA, XGEVA, biosimilars, osteoporosis, oncology bone events
Entera Bio: EB613, oral PTH(1-34), oral teriparatide, postmenopausal osteoporosis, total hip BMD, N-Tab platform
Houston Methodist: second harmonic generation microscopy, SHG, papillary thyroid cancer, collagen signatures, thyroid nodules
References
- https://www.prnewswire.com/news-releases/lygenesis-receives-award-from-breakthrough-t1d-to-fund-a-research-project-to-induce-immune-tolerance-to-pancreatic-islet-transplantation-302810495.html
- https://firstwordpharma.com/story/7643148
- https://www.reuters.com/business/healthcare-pharmaceuticals/glp-1s-linked-smell-taste-impairment-diabetes-patients-2026-06-26/
- https://www.endocrinologyadvisor.com/news/testosterone-levels-incident-type-2-diabetes-risk-men/
- https://www.theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/3003217/lilly-targets-youth-diabetes-with-new-oral-glp-1-trial-expanding-its-glp-1-footprint/
- https://www.organon.com/canada-en/organon-canada-and-henlius-expand-access-to-denosumab-treatments-with-launch-of-bildyos-denosumab-injection-and-tuzemty-denosumab-injection-biosimilars-to-prolia-and-xgeva/
- https://www.globenewswire.com/news-release/2026/06/23/3315992/0/en/positive-fda-feedback-on-phase-3-brings-entera-bio-s-oral-osteoporosis-pill-one-step-closer-to-market.html
- https://medicalxpress.com/news/2026-06-based-imaging-thyroid-cancer-diagnosis.html
