---
title: "Key Developments in Endocrinology for October 16, 2026"
id: "endocrine-news-0-pharma-friday-october-16-2026"
canonical_url: "https://medichelpline.com/clinical-feed/endocrine-news-0-pharma-friday-october-16-2026"
content_type: "clinical_feed_article"
specialty: "Endocrinology"
source_name: "Endocrine News"
source_url: "https://endocrinenews.endocrine.org/pharma-friday-october-16-2026/"
published_at: "2026-10-16T16:31:00.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Key Developments in Endocrinology for October 16, 2026
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/endocrine-news-0-pharma-friday-october-16-2026
- **Specialty:** [Endocrinology](https://medichelpline.com/clinical-feed/endocrinology.md)
- **Primary Source:** Endocrine News
- **Source URL:** [Original Journal Publication](https://endocrinenews.endocrine.org/pharma-friday-october-16-2026/)
- **Published At:** 2026-10-16T16:31:00.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- **Ascendis Pharma** received a positive CHMP opinion for **TransCon CNP** for treating **achondroplasia** in children. Final EC decision anticipated in Q4 2026. - **SAB Biotherapeutics** gained FDA Fast Track designation for **SAB-142**, an immunotherapy for **Stage 3 type 1 diabetes**. - **Insulet Corporation** launched **Omnipod Discover™**, a data platform enhancing diabetes management for **Omnipod 5** users in the U.S. - **VeraMorph** is developing an oral formulation of **fulvestrant** for **ER+ metastatic breast cancer**, with positive preclinical results and NIH funding. - **Rezolute, Inc.** completed enrollment in their Phase 3 **upLIFT** study for **ersodetug** in tumor-induced **hyperinsulinism**.
## Clinical Analysis & Structured Key Points
[Skip to content](https://endocrinenews.endocrine.org/pharma-friday-october-16-2026/#wp--skip-link--target) [Endocrine News](https://endocrinenews.endocrine.org) [![Endocrine News](https://endocrinenews.endocrine.org/wp-content/uploads/es-reversed.svg)](https://endocrinenews.endocrine.org/) * [Topics](https://endocrinenews.endocrine.org/category/health-topic/diabetes/) * [Diabetes](https://endocrinenews.endocrine.org/category/health-topic/diabetes/) * [Obesity](https://endocrinenews.endocrine.org/category/health-topic/obesity/) * [Adrenal](https://endocrinenews.endocrine.org/category/health-topic/adrenal/) * [Bone and Mineral](https://endocrinenews.endocrine.org/category/health-topic/bone-and-mineral/) * [Cardiometabolic](https://endocrinenews.endocrine.org/category/health-topic/cardiometabolic/) * [Endocrine Disruptors](https://endocrinenews.endocrine.org/category/health-topic/endocrine-disruptors/) * [Head Glands](https://endocrinenews.endocrine.org/category/health-topic/head-glands/) * [Kidney Issues](https://endocrinenews.endocrine.org/category/health-topic/kidney-issues/) * [Neoplasia and Cancer](https://endocrinenews.endocrine.org/category/health-topic/neoplasia-and-cancer/) * [Pancreas](https://endocrinenews.endocrine.org/category/health-topic/pancreas/) * [Reproductive Issues](https://endocrinenews.endocrine.org/category/health-topic/reproductive-issues/) * [Thyroid](https://endocrinenews.endocrine.org/category/health-topic/thyroid/) * [Pediatric Health](https://endocrinenews.endocrine.org/category/patient-populations/pediatric-health/) * [Men’s Health](https://endocrinenews.endocrine.org/category/patient-populations/mens-health/) * [Women’s Health](https://endocrinenews.endocrine.org/category/patient-populations/womens-health/) * [Why Endocrinology?](https://endocrinenews.endocrine.org/category/why-endocrinology/) * [Practice](https://endocrinenews.endocrine.org/category/practice/) * [Your Practice](https://endocrinenews.endocrine.org/category/practice/your-practice/) * [Your Patients](https://endocrinenews.endocrine.org/category/practice/your-patients/) * [Product / Technology](https://endocrinenews.endocrine.org/category/practice/product-technology/) * [Endocrinology Workforce](https://endocrinenews.endocrine.org/category/endocrinology-workforce/) * [Lab Notes](https://endocrinenews.endocrine.org/category/lab-notes/) * [Q&A](https://endocrinenews.endocrine.org/category/lab-notes/q-a/) * [Your Laboratory](https://endocrinenews.endocrine.org/category/your-laboratory/) * [Products and Technological Advancements in Endocrinology](https://endocrinenews.endocrine.org/category/lab-notes/products-technology/) * [Advocacy](https://endocrinenews.endocrine.org/category/advocacy/) * [Clinical](https://endocrinenews.endocrine.org/category/advocacy/clinical/) * [Research](https://endocrinenews.endocrine.org/category/advocacy/research/) * [InTouch](https://endocrinenews.endocrine.org/intouch/) * [Member News](https://endocrinenews.endocrine.org/category/in-touch/member-news-in-touch/) * [Society News](https://endocrinenews.endocrine.org/category/in-touch/society-news/) * [Podcast](https://www.endocrine.org/podcast) * [Current Issue Download](https://endocrinenews.endocrine.org/magazine/current-issue/) * [My Profile](https://ams.endocrine.org/eweb/) * [Log In](https://endocrinenews.endocrine.org/auth/login) * [Log Out](https://endocrinenews.endocrine.org/auth/logout) * [Topics](https://endocrinenews.endocrine.org/category/health-topic/diabetes/) * [Diabetes](https://endocrinenews.endocrine.org/category/health-topic/diabetes/) * [Obesity](https://endocrinenews.endocrine.org/category/health-topic/obesity/) * [Adrenal](https://endocrinenews.endocrine.org/category/health-topic/adrenal/) * [Bone and Mineral](https://endocrinenews.endocrine.org/category/health-topic/bone-and-mineral/) * [Cardiometabolic](https://endocrinenews.endocrine.org/category/health-topic/cardiometabolic/) * [Endocrine Disruptors](https://endocrinenews.endocrine.org/category/health-topic/endocrine-disruptors/) * [Head Glands](https://endocrinenews.endocrine.org/category/health-topic/head-glands/) * [Kidney Issues](https://endocrinenews.endocrine.org/category/health-topic/kidney-issues/) * [Neoplasia and Cancer](https://endocrinenews.endocrine.org/category/health-topic/neoplasia-and-cancer/) * [Pancreas](https://endocrinenews.endocrine.org/category/health-topic/pancreas/) * [Reproductive Issues](https://endocrinenews.endocrine.org/category/health-topic/reproductive-issues/) * [Thyroid](https://endocrinenews.endocrine.org/category/health-topic/thyroid/) * [Pediatric Health](https://endocrinenews.endocrine.org/category/patient-populations/pediatric-health/) * [Men’s Health](https://endocrinenews.endocrine.org/category/patient-populations/mens-health/) * [Women’s Health](https://endocrinenews.endocrine.org/category/patient-populations/womens-health/) * [Why Endocrinology?](https://endocrinenews.endocrine.org/category/why-endocrinology/) * [Practice](https://endocrinenews.endocrine.org/category/practice/) * [Your Practice](https://endocrinenews.endocrine.org/category/practice/your-practice/) * [Your Patients](https://endocrinenews.endocrine.org/category/practice/your-patients/) * [Product / Technology](https://endocrinenews.endocrine.org/category/practice/product-technology/) * [Endocrinology Workforce](https://endocrinenews.endocrine.org/category/endocrinology-workforce/) * [Lab Notes](https://endocrinenews.endocrine.org/category/lab-notes/) * [Q&A](https://endocrinenews.endocrine.org/category/lab-notes/q-a/) * [Your Laboratory](https://endocrinenews.endocrine.org/category/your-laboratory/) * [Products and Technological Advancements in Endocrinology](https://endocrinenews.endocrine.org/category/lab-notes/products-technology/) * [Advocacy](https://endocrinenews.endocrine.org/category/advocacy/) * [Clinical](https://endocrinenews.endocrine.org/category/advocacy/clinical/) * [Research](https://endocrinenews.endocrine.org/category/advocacy/research/) * [InTouch](https://endocrinenews.endocrine.org/intouch/) * [Member News](https://endocrinenews.endocrine.org/category/in-touch/member-news-in-touch/) * [Society News](https://endocrinenews.endocrine.org/category/in-touch/society-news/) * [Podcast](https://www.endocrine.org/podcast) * [Current Issue Download](https://endocrinenews.endocrine.org/magazine/current-issue/) * [My Profile](https://ams.endocrine.org/eweb/) * [Log In](https://endocrinenews.endocrine.org/auth/login) * [Log Out](https://endocrinenews.endocrine.org/auth/logout) Search Search [Current Issue Download](https://endocrinenews.endocrine.org/magazine-issues/october-2026/) [Login](https://endocrinenews.endocrine.org/auth/login/?redirect=https://endocrinenews.endocrine.org/pharma-friday-october-16-2026/) ![](https://endocrinenews.endocrine.org/wp-content/themes/mg-starter/assets/images/Endocrine_News_standard_logo.svg) * * * # Pharma Friday – October 16, 2026 October 16, 2026 Print this article Share this article ![](https://endocrinenews.endocrine.org/wp-content/uploads/pharmaaaaa3.jpg) #### An _Endocrine News_ roundup of the week’s pharmaceutical news, breakthroughs, and general information. * ## Once-Weekly TransCon® CNP (Navepegritide) Receives Positive CHMP Opinion for the Treatment of Achondroplasia in Children On October 16, Ascendis Pharma A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for once-weekly TransCon CNP (navepegritide) in the European Union for the treatment of achondroplasia in children two years of age and older whose epiphyses are not closed. The final European Commission (EC) decision on Ascendis Pharma’s Marketing Authorisation Application (MAA) is expected during Q4 2026. ![](https://endocrinenews.endocrine.org/wp-content/uploads/ascendis-final-logo-7-23-15-1-1024x343.png) “We are pleased to receive this positive opinion reflecting the unique profile of TransCon CNP,” said Jan Mikkelsen, president and chief executive officer at Ascendis Pharma. “With a highly favorable response from the achondroplasia community to its differentiated profile, TransCon CNP remains a foundational product in our growth disorder portfolio, positioned to support our Vision 2030 objectives.” CHMP adopted its positive opinion following its review of the MAA for TransCon CNP, which included clinical data from three randomized, double-blind, placebo-controlled clinical trials and up to three years of open-label extension data. The pivotal ApproaCH Trial data is available in _JAMA Pediatrics_. TransCon CNP was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained. If authorized by the EC, Ascendis expects its first EU launch of TransCon CNP under the brand name YUVIWEL® to be in Germany during Q1 2027. #### **About Achondroplasia** Achondroplasia is a rare genetic condition arising from a systemic fibroblast growth factor receptor 3 (FGFR3) variant that leads to an imbalance in the effects of the FGFR3 and CNP signaling pathways, estimated to affect more than 250,000 people worldwide. While historically considered a bone growth disorder, the FGFR3 variant seen in achondroplasia is expressed in tissues throughout the body, causing serious muscular, neurological, and cardiorespiratory complications in addition to skeletal dysplasia. Medical complications of achondroplasia vary across different stages of life. Throughout infancy and childhood, observed complications include spinal abnormalities, enlarged brain ventricles, impaired muscle strength and stamina, hearing deficits and chronic ear infections, upper airway obstructions, sleep-disordered breathing, hip problems, leg bowing, and chronic pain; many of these persist or worsen in adulthood. These medical complications can affect physical well-being and quality of life, and may be impacted by a range of individual, clinical, and social factors. Some individuals with achondroplasia require multiple procedures and surgeries to address specific functional or anatomical concerns. ## SAB BIO Receives FDA Fast Track Designation for SAB-142 in Stage 3 Type 1 Diabetes On October 13, **[SAB Biotherapeutics, Inc.](https://www.sab.bio/)** , announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SAB-142, a potentially disease-modifying immunotherapy being developed for the treatment of individuals with new-onset Stage 3 type 1 diabetes. SAB Biotherapeutics, Inc., is a clinical-stage biopharmaceutical company developing a fully human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes and other autoimmune diseases. ![](https://endocrinenews.endocrine.org/wp-content/uploads/SAB_BIO_Primary_Logo_Color_CMYK_6in_w_300ppi-002-1024x421.jpg) Fast Track designation is intended to facilitate the development and expedite the review of therapies for serious conditions where there is an unmet medical need and to help bring important new treatments to patients earlier. “Receiving FDA Fast Track designation is an important regulatory milestone for SAB-142 and reflects the agency’s determination that the program has the potential to address an unmet medical need for people diagnosed with type 1 diabetes,” said **Samuel J. Reich, Chief Executive Officer of SAB BIO**. “We look forward to continuing to work closely with the FDA as we advance the SAB-142 clinical program. This designation represents meaningful progress toward our goal of bringing SAB-142 to people living with type 1 diabetes as quickly as possible and transforming the meaning of a type 1 diabetes diagnosis.” SAB-142 is currently being evaluated in the registrational Phase 2b SAFEGUARD study in people within 100 days of a Stage 3 type 1 diabetes diagnosis, with enrollment expected to be completed in Q4 2026 and topline data anticipated in 2H 2027. The program is further supported by the investigator-led Phase 3 PRISE-hATG study, which is designed to evaluate SAB-142 in people with Stage 3 type 1 diabetes from 100 days to two years following diagnosis. ## Insulet’s Omnipod Now Available in the U.S. On October 12, **[Insulet Corporation](https://www.insulet.com/)** announced the U.S. full market release of Omnipod Discover**™** ,a web-based data platform designed for Omnipod 5 users, their caregivers, and healthcare providers (HCPs). Omnipod Discover turns critical diabetes data into clear visualizations and personalized insights, giving people with diabetes and their HCPs a shared understanding of therapy patterns to make more informed diabetes management decisions. “The future of diabetes care is not just about generating more data, it’s about making that data meaningful,” said Trang Ly, MBBS, FRACP, PhD, senior vice president and chief medical officer at Insulet. “Omnipod Discover simplifies data review for Omnipod 5 users and their healthcare providers so they spend less time gathering information and more time collaborating on diabetes management.” With Omnipod Discover, Omnipod 5 users get simple, personalized glucose and insulin delivery reports sent directly to their smartphone weekly, so they know where to focus their diabetes management efforts. Omnipod Discover also helps HCPs make confident clinical recommendations from a concise report by overlaying a licensed Ambulatory Glucose Profile (AGP) with key adjustable pump settings and bolus events. ![](https://endocrinenews.endocrine.org/wp-content/uploads/logo_insulet_grape_rgb_no-tagline_2000x983-1024x503.jpg) Omnipod Discover has already been adopted in the United States by more than 15,000 Omnipod 5 users and over 1,800 healthcare professionals as part of Insulet’s limited market release program in the U. S. It is also available to users and HCPs in Spain, Australia, Saudi Arabia, Qatar, Kuwait, UAE, and Israel. “In today’s AID (automated insulin delivery) era, clinicians need actionable insights, not more data. Omnipod Discover brings key diabetes metrics and insights together in a streamlined, easy-to-use workflow that supports clinical decision-making and patient conversations,” said Martin Sarkar, DO, ECNU, endocrinologist at EndoCARE Diabetes & Wellness Center in Frederick, Md. “It also gives people with diabetes greater visibility into their therapy, helping foster engagement and trust. Omnipod Discover is an important step toward a more connected diabetes ecosystem that supports both providers and patients.” In June, Insulet presented Real-World Glycemic Outcomes using the Omnipod Discover platform at the American Diabetes Association’s Scientific Sessions in New Orleans, La. Use of Omnipod Discover was associated with improvements in time in range (TIR), with 32% of users seeing a clinically meaningful increase in TIR of 3% or more. These findings support the vital role that user engagement with Omnipod Discover can play in diabetes self-management. The platform is now available to all Omnipod 5 users nationwide, with healthcare professionals able to enroll through onboarding and training provided by their dedicated Omnipod sales representative. ## **VeraMorph Completes Positive Pre-IND Meeting on Oral Fulvestrant Product, Receives NIH Grant** Veramorph LLC ([VeraMorph](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.veramorph.com&esheet=54622371&newsitemid=20261014279184&lan=en-US&anchor=VeraMorph&index=1&md5=58253027d23517e42ef1f9e90d2e4dfb)) is a specialty pharmaceutical company utilizing its “degradable gel” oral drug delivery platform to develop a pipeline of clinically differentiated orally reformulated drug products. The lead product is the first effective oral formulation of fulvestrant, which is the potential best in class endocrine therapy for estrogen receptor positive (ER+) metastatic breast cancer (mBC) patients without ESR1 gene mutations. ![](https://endocrinenews.endocrine.org/wp-content/uploads/veramorph-logo.jpg) The potential clinical benefit of orally administered fulvestrant is to prolong survival and improve compliance, which is typically correlated with better outcomes, and quality of life for ER+ mBC patients. VeraMorph’s degradable gel technology will enable this outcome by maximizing the drug’s oral bioavailability, which has already demonstrated 20 times higher maximum plasma concentrations in preclinical studies relative to the current injectable product without generating severe adverse events. The initial beneficiaries of oral fulvestrant’s improved exposure are the roughly 70% of ER+ mBC patients that retain a wild-type ESR1 gene. Several oral alternatives to fulvestrant have been approved for patients with ESR1 mutations after progression on a prior endocrine therapy (i.e., in the second line setting). In contrast, fulvestrant efficacy is independent of ESR1 mutation status. With this context, an oral fulvestrant product could capture a substantial portion of the estimated $3B to $6B oral selective estrogen receptor degrader (SERD) therapy market. VeraMorph plans to develop a dosage strength of oral fulvestrant that achieves an equivalent area under the curve (AUC) over 28 days relative to the approved monthly injectable product. The proposed clinical strategy comprises an initial dose range finding study, a PK bridging study, and an additional safety study given the new route of administration and use of a novel excipient. During a pre-IND meeting, the FDA conveyed openness to the proposed clinical strategy that entails generating clinical data from healthy volunteers. Based on this feedback, VeraMorph expects to submit an NDA in 2029. Using funds from an SBIR Phase I grant sponsored by the NIH, VeraMorph recently replicated results indicating non-inferior efficacy of oral fulvestrant relative to the approved injectable product in orthotopic and metastatic models of ER+ mBC. Based on these positive results, VeraMorph has received a $2.1M NIH SBIR Phase II grant in order to complete remaining IND-enabling studies on oral fulvestrant as well as PDX studies to generate additional preclinical proof of concept data. These studies will enable VeraMorph to bring oral fulvestrant into the clinic in 2027. VeraMorph is actively raising a Seed round to finance the upcoming dose ranging study on oral fulvestrant, including the scale-up of production processes for the degradable gel technology and corresponding oral solid dosages to produce clinical trial material. These funds will enable validation of the safety and effectiveness of VeraMorph’s platform technology and the oral fulvestrant product in humans. All of these efforts are aligned with VeraMorph’s mission, which is to improve and prolong the lives of patients across all indications with cost-effective therapies by enabling the full potential of existing therapies. ## Rezolute Announces Completion of Enrollment in Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism On October 14, **Rezolute, Inc.** , a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), announced that the open-label Phase 3 study of ersodetug in tumor HI (upLIFT) is now fully enrolled and topline data are expected mid-December 2026. The company plans to continue its expanded access program for purposes of providing ersodetug on a compassionate use basis to individuals living with serious and refractory hypoglycemia due to tumor HI. ![](https://endocrinenews.endocrine.org/wp-content/uploads/Rezolute-Logo.jpg) The upLIFT study is a single-arm, open-label, registrational study in 16 participants with insu
## Related Clinical Research

- [Pharma Friday roundup: FDA OKs Emcitate for MCT8 deficiency; Lynkuet priority review; Lilly’s Onsw](https://medichelpline.com/clinical-feed/endocrine-news-0-pharma-friday-oct-2-2026.md)
- [Representative Kim Schrier Named Democratic Co-Chair of Congressional Diabetes Caucus](https://medichelpline.com/clinical-feed/endocrine-news-1-representative-kim-schrier-to-serve-as-diabetes-caucus-co-chair-starting-in.md)
- [Higher moderate-to-vigorous physical activity linked to lower type 2 diabetes risk](https://medichelpline.com/clinical-feed/medical-news-today-0-more-moderate-to-vigorous-physical-activity-could-reduce-type-2-diabetes-risk.md)
- [Scalable encapsulation of pluripotent stem cell-derived islets in high-concentration alginate bead](https://medichelpline.com/clinical-feed/biorxiv-13-bridging-scale-up-to-transplantation-pluripotent-stem-cell-derived-pancreatic.md)
- [GLP-1 receptor agonists and PMOS: evidence, mechanisms, and who may benefit](https://medichelpline.com/clinical-feed/medical-news-today-0-can-glp-1s-really-help-treat-pmos-experts-answer-3-key-questions.md)

## Navigation
- [← Back to Endocrinology Feed](https://medichelpline.com/clinical-feed/endocrinology.md)
- [← All Clinical Specialties](https://medichelpline.com/clinical-feed.md)
## Medical & Regulatory Disclaimer

> [!CAUTION]
> MedicHelpline content is structured for research, educational, and professional discovery purposes. It does not constitute individual medical advice, clinical diagnosis, or treatment recommendations.
> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.