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. (NASDAQ: ENTX) generates a steady flow of news as a clinical-stage biopharmaceutical company developing oral peptide and protein replacement therapies. News coverage on this page focuses on the company’s progress with its proprietary N-Tab™ oral peptide platform and its pipeline of tablet-based biologic candidates.
Investors and followers of ENTX can use this news feed to track key developments around EB613, Entera Bio’s lead oral PTH(1-34) (teriparatide) osteoanabolic tablet for postmenopausal women with osteoporosis or low bone mineral density. Updates often include Phase 2 clinical data, post-hoc analyses of bone mineral density outcomes, presentations at bone and endocrine conferences, and regulatory milestones such as FDA alignment on Phase 3 trial design and acceptance of total hip BMD as a primary endpoint.
The news stream also highlights progress in the EB612 program for hypoparathyroidism, including preclinical pharmacokinetic and pharmacodynamic data for a proprietary long-acting PTH analog formulated as a once-daily oral tablet. Coverage extends to Entera Bio’s collaboration with OPKO Health on oral GLP-2 and oxyntomodulin tablet candidates, with reports on preclinical data for short bowel syndrome and obesity programs presented at international nutrition and endocrine meetings.
In addition, readers will find quarterly financial results, business updates, participation in healthcare and investor conferences, and commentary from company leadership on strategy and clinical priorities. This page brings together ENTX press releases and related announcements so that investors, clinicians and other stakeholders can follow the company’s clinical, regulatory and collaboration milestones in one place.
Entera Bio (NASDAQ: ENTX) reported preclinical PK–PD data for its EB612 program showing a proprietary long-acting PTH analog administered as a single oral tablet produced a markedly longer plasma half-life and sustained serum calcium elevation for >3 days in a five‑animal minipig study versus unmodified PTH(1‑34) controls, which showed no calcium response. The company said no adverse events were observed and positions the data as support for development of a once-daily oral PTH tablet for hypoparathyroidism. Entera plans to present the data at an upcoming medical conference.
Entera Bio (Nasdaq: ENTX) announced that CEO Miranda Toledano will participate in a fireside chat at the 8th Annual Evercore ISI Healthcare Conference on Dec 3, 2025 at 9:10–9:30 AM local time in Sevilla A.
The company said the event is in person in Coral Gables, Florida (Dec 3–5) and will be webcast live with a replay available for 90 days. Entera is a clinical-stage developer of oral peptide and protein replacement therapies using its N-Tab platform; lead candidate EB613 showed positive Phase 2 biomarker and BMD results in a 161-patient study.
Entera Bio (NASDAQ: ENTX) reported Q3 2025 results and program updates on November 14, 2025. The FDA agreed that a single 24-month multinational Phase 3 of EB613 with change in total hip BMD as the primary endpoint and new/worsening vertebral fractures as key secondary would support an NDA.
Phase 2 data showed rapid gains in trabecular and cortical bone indices and consistent BMD increases in women within 10 years of menopause. Cash and cash equivalents totaled $16.6 million (including $8.0M restricted), net loss was $3.2M for Q3, and cash runway is expected through the middle of Q3 2026. GLP-2 PK showed ~15‑hour half-life (18x improvement vs teduglutide); IND for oral OXM planned H1 2026.
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.