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. develops orally delivered peptide and protein replacement therapies as a clinical-stage biopharmaceutical company. News about ENTX centers on its N-Tab® oral peptide platform and pipeline candidates, including EB613, an oral PTH(1-34) tablet for osteoporosis, and EB612, a long-acting oral PTH peptide replacement tablet for hypoparathyroidism.
Recurring updates also cover FDA communications and clinical-development plans, OPKO collaboration activity, financial results, private placements and warrant-linked capital actions, board and governance changes, and medical-community discussions around osteoporosis and oral anabolic therapy.
Entera Bio (Nasdaq: ENTX) reported a post-hoc analysis from its Phase 2 EB613 trial showing significant bone mineral density (BMD) gains at six months in early postmenopausal women (≤10 years since last menstrual period) presented at NAMS on Oct 23, 2025. At the 2.5 mg dose, EB613 vs placebo produced lumbar spine +3.1% (p=0.05), total hip +2.3% (p=0.03), and femoral neck +2.0% in the early postmenopausal subgroup (n=8 treated, n=19 placebo). Results were comparable to women >10 years post-menopause (femoral neck +3.2%, p=0.02; lumbar spine +2.5%, p=0.08). Entera plans a global registrational Phase 3 study after July 2025 FDA concurrence, positioning EB613 as a potential first-in-class oral anabolic option to expand access to bone-building therapy.
Entera Bio (NASDAQ: ENTX) will present new Phase 2 clinical data for EB613 at the North American Menopause Society (NAMS) 2025 Annual Meeting in Orlando, Oct 21–25, 2025.
The poster (P-66) reports six-month bone mineral density (BMD) outcomes in early postmenopausal women with low bone mass or osteoporosis, evaluating oral PTH[1-34] tablets as a potential anabolic option earlier in treatment where injectables are underutilized. Presentation is a poster session on Oct 23, 2025, 6:15–7:15 PM in Windemere Exhibit Hall.
Entera Bio (NASDAQ: ENTX) presented positive pharmacokinetic data for its first-in-class oral GLP-2 tablet (OPK-8801003) at the 2025 ESPEN Congress. The treatment, developed in collaboration with OPKO Health, aims to revolutionize care for 30,000 Short Bowel Syndrome (SBS) patients currently dependent on daily injections.
The preclinical data showed remarkable results: a 15-hour plasma half-life (18x longer than current treatment Gattex®), peak plasma concentrations of ~200 ng/ml, and sustained exposure for over 24 hours. The current GLP-2 market leader, Gattex®, generates $800 million in annual sales despite requiring daily subcutaneous injections.
Entera Bio (NASDAQ: ENTX) presented positive Phase 2 clinical data for EB613, its oral treatment for postmenopausal osteoporosis, at the ASBMR 2025 Annual Meeting. The study demonstrated significant improvements in both trabecular and cortical bone after 6 months of treatment.
Key results include increases in femoral neck trabecular volumetric BMD by 4.4% vs placebo (p0.03) and improvements in cortical surface BMD. The company also presented promising pharmacokinetic data for its Next-Gen EB613 single tablet candidate, with plans to initiate a Phase 1 trial in late 2025.Following FDA concurrence in July 2025, Entera Bio plans to initiate a global registrational Phase 3 study. The development aims to address the treatment gap in osteoporosis care, as less than 30% of at-risk patients currently receive adequate treatment with available medications.
Entera Bio (NASDAQ: ENTX), a developer of oral peptides and proteins replacement therapies, will present data from three key programs at major conferences in September 2025. The presentations include clinical data for EB613, their oral PTH(1-34) tablet for osteoporosis treatment, at ASBMR 2025, featuring results from a Phase 2 study of 161 post-menopausal women.
The company will also present data on their Next-Gen EB613 tablet and a novel oral GLP-2 analog for Short Bowel Syndrome at ESPEN Congress. Additionally, CEO Miranda Toledano will deliver a corporate overview at the H.C. Wainwright Global Investment Conference.
Entera Bio (NASDAQ:ENTX) reported significant progress in Q2 2025, highlighted by FDA's agreement on using Bone Mineral Density (BMD) as the primary endpoint for EB613's Phase 3 program - a potential first oral anabolic osteoporosis treatment. The FDA also waived requirements for additional safety studies, streamlining the regulatory pathway.
The company maintains a strong financial position with $18.9 million in cash, including $8.0 million restricted for OPKO collaboration, providing runway through mid-Q3 2026. Q2 resulted in a net loss of $2.7 million ($0.06 per share), compared to $2.1 million in Q2 2024.
Pipeline developments include promising preclinical data for their obesity program with OPKO, featuring oral GLP-1/glucagon dual agonist showing comparable plasma levels to Wegovy™. Additionally, their next-generation EB613 is expected to enter Phase 1 trials in November 2025.
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.