Welcome to our dedicated page for Entera Bio news (Ticker: ENTX), a resource for investors and traders seeking the latest updates and insights on Entera Bio stock.
Entera Bio Ltd (ENTX) is a clinical-stage biopharmaceutical company pioneering oral peptide therapies for chronic conditions like osteoporosis and hypoparathyroidism. This page provides investors and industry professionals with timely updates on the company’s clinical trials, regulatory milestones, and strategic initiatives.
Access the latest press releases and news about Entera Bio’s proprietary drug delivery platform, which aims to transform treatment paradigms by replacing injectable therapies with oral alternatives. Track developments across their pipeline, including phase advancements for lead candidates and collaborations advancing oral macromolecule research.
Key updates include progress on EB613 for bone health, EB612 for hormone regulation, and innovations in peptide absorption technology. Bookmark this page to stay informed about financial disclosures, partnership announcements, and scientific breakthroughs directly from the source.
Entera Bio (NASDAQ: ENTX) has received FDA agreement on using Bone Mineral Density (BMD) as the primary endpoint for its Phase 3 study of EB613, an oral treatment for post-menopausal osteoporosis. The FDA approved a 24-month phase 3 study design where total hip BMD will be the primary endpoint, with vertebral fractures as a secondary endpoint.
This represents a significant shift from traditional osteoporosis drug trials that required fracture incidence as the primary endpoint. The development aims to create the first oral, once-daily anabolic tablet for osteoporosis treatment, addressing a market of over 200 million women globally who suffer from the condition.
Entera Bio (NASDAQ: ENTX) and OPKO Health (NASDAQ: OPK) announced their abstract on oral GLP-2 tablet treatment for Short Bowel Syndrome (SBS) has been selected for presentation at the 47th ESPEN Congress in Prague (September 13-16, 2025).
The program combines OPKO's proprietary long-acting GLP-2 agonist with Entera's N-Tab™ technology, aiming to provide an oral alternative to GATTEX® (teduglutide), which currently requires daily subcutaneous injections. The oral tablet format could potentially improve treatment compliance and enable more personalized care for SBS patients.
Entera Bio (NASDAQ: ENTX) announced that new data for its EB613 oral PTH(1-34) tablet for osteoporosis treatment will be presented at the ASBMR 2025 Annual Meeting. The Phase 2 study involved 161 postmenopausal women with low bone mass or osteoporosis, testing four dose levels against placebo for 6 months.
The study demonstrated that EB613 significantly increased BMD at measured skeletal sites compared to baseline and placebo, with biochemical markers suggesting dual effects of stimulating formation and inhibiting bone resorption. The company aims to develop EB613 as the first once-daily oral anabolic treatment for postmenopausal women with high-risk osteoporosis.
Entera Bio (NASDAQ: ENTX) and OPKO Health (NASDAQ: OPK) announced their abstract for oral OPK-88006, a first-in-class dual GLP-1/glucagon agonist tablet, has been selected for presentation at ENDO 2025 in San Francisco. The drug candidate, developed through their collaboration, is being advanced as both a once-daily tablet and a weekly subcutaneous injection for treating obesity and metabolic disorders.
The oral formulation combines OPKO's long-acting oxyntomodulin analog with Entera's N-Tab™ technology. The companies plan to file an IND application with the FDA later in 2025 for both formulations, followed by Phase 1 clinical studies.
Entera Bio (NASDAQ: ENTX) presented promising Phase 2 study results for EB613, their innovative once-daily oral PTH(1-34) tablet for postmenopausal osteoporosis treatment, at the 2025 WCO-IOF-ESCEO Congress in Rome.
The study involving 161 postmenopausal women demonstrated that after 6 months of treatment, EB613 showed significant improvements in bone mineral density (BMD) compared to placebo. The 3D-DXA analysis revealed increases in integral volumetric BMD, trabecular volumetric BMD, cortical thickness, and cortical surface BMD.
The results indicate early beneficial effects on both trabecular and cortical bone of the proximal femur, suggesting potential rapid bone strengthening and fracture resistance. This development is particularly significant as postmenopausal osteoporosis affects an estimated 200 million women globally, with 50% of women over 50 at risk of fragility fractures.
Entera Bio (NASDAQ: ENTX) reported its financial results for 2024, marking a transformational year in developing oral peptide therapies. The company's flagship product, EB613, the first oral PTH(1-34) tablet for osteoporosis, made significant progress with published Phase 2 trial results in JBMR.
Key developments include successful results in their GLP-1/Glucagon program with OPKO Health, showing significant systemic exposure and glucose reduction. The company also advanced their GLP-2 peptide tablets program for Short Bowel Syndrome, demonstrating 10-fold higher plasma levels compared to existing treatments.
Financial highlights: Cash position of $21 million as of March 2025, sufficient until Q3 2026. R&D expenses remained stable at $4.5 million, while G&A expenses increased to $5.1 million. Net loss for 2024 was $9.5 million ($0.25 per share) compared to $8.9 million ($0.31 per share) in 2023.
OPKO Health (NASDAQ: OPK) and Entera Bio (NASDAQ: ENTX) have formed a collaboration agreement to develop the first oral dual agonist GLP-1/glucagon peptide tablet for treating obesity and metabolic disorders. The program combines OPKO's OPK-88006 with Entera's N-Tab™ technology, following favorable data reported in September 2024.
The partnership structure gives OPKO a 60% ownership stake and Entera a 40% stake, with corresponding cost-sharing responsibilities. OPKO has purchased 3,685,226 Entera shares at $2.17 per share, with proceeds funding Entera's Phase 1 development costs. Post-Phase 1, Entera can maintain its 40% stake by continuing funding, or opt-out to retain 15% ownership while OPKO increases to 85%.
The companies plan to file an Investigational New Drug application with the FDA later this year. The treatment utilizes oxyntomodulin, a natural hormone that suppresses appetite, induces weight loss, and offers cardioprotective and anti-fibrotic benefits. Currently, no approved dual GLP-1/Glucagon agonists exist in the market.
Entera Bio (NASDAQ: ENTX), a pioneer in developing oral peptide and protein replacement therapies in tablet form, has announced its participation in three major upcoming events in 2025.
The company will attend the Leerink Partners Global Healthcare Conference on March 12 in Miami, FL, where they will conduct in-person one-on-one meetings. At the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO), Entera will deliver an oral presentation on April 11 at 10:00 GMT in the Roma Convention Center's Auditorium A, followed by a poster presentation (Poster #P1265) on April 13 from 8:30-13:00. Additionally, the company will participate in the BIO International Convention scheduled for June 16-19 at the Boston Convention & Exhibition Center.
Entera Bio (NASDAQ: ENTX) announced that two abstracts related to EB613, their oral PTH(1-34) tablet treatment for post-menopausal osteoporosis, have been accepted for presentation at the WCO-IOF-ESCEO congress in Rome (April 10-13, 2025). The presentations will focus on the effects of EB613 on trabecular and cortical bone using 3D-DXA, and its impact on bone modeling versus remodeling.
In a Phase 2 placebo-controlled study, EB613 demonstrated rapid onset and significant BMD increases across all skeletal sites over 6 months, along with increased bone formation (P1NP) and reduced bone resorption (CTX). The treatment is being developed as the first once-daily oral anabolic therapy for high-risk post-menopausal women with osteoporosis, targeting a condition that affects an estimated 200 million women globally.
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