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 Ltd. (NASDAQ: ENTX) announced a conference call to discuss the results of its successful Phase 2 clinical trial of EB613 for osteoporosis treatment. EB613 is an oral formulation of human parathyroid hormone (1-34) intended to be the first oral anabolic product for osteoporosis patients. The call will include insights from Dr. Liana Tripto-Shkolnik and Entera's leadership team, scheduled for June 30, 2021. Entera aims to address the challenges of delivering large molecules orally, with EB613 and EB612 currently in Phase 2 development.
Entera Bio Ltd. (NASDAQ: ENTX) announced significant results from its Phase 2 trial of EB613, an oral treatment for osteoporosis. The 2.5 mg dose showed a 3.78% increase in lumbar spine BMD after 6 months, exceeding placebo. The study met its primary endpoint with a statistically significant rise in P1NP, a bone formation biomarker. EB613 demonstrated an excellent safety profile, with no serious drug-related adverse events. An End of Phase 2 meeting with the FDA is anticipated to discuss advancing to a pivotal Phase 3 study against Forteo, highlighting EB613's potential as the first oral anabolic therapy for osteoporosis.
Entera Bio Ltd. (NASDAQ: ENTX) has been granted a critical European patent for its oral delivery technology aimed at large molecule therapeutics, particularly for osteoporosis and hypoparathyroidism. This patent enhances Entera's intellectual property portfolio, facilitating its leadership in the oral delivery of proteins. The company anticipates releasing final bone mineral density (BMD) results from its Phase 2 study of EB 613 in Q2 2021, with plans to pursue a pivotal Phase 3 study next year, provided data are favorable.
Entera Bio Ltd. (NASDAQ: ENTX) announced positive outcomes from its Phase 2 EB613 clinical trial for osteoporosis, achieving its primary 3-month efficacy endpoint. The study recorded significant increases in bone formation biomarkers in the 2.5 mg dose group. Financial results for Q1 2021 showed revenues of $157,000, up from $42,000 year-over-year, but a net comprehensive loss of $9.5 million or $0.43 per share. Entera maintains a healthy cash position of over $16 million, expected to sustain operations until Q2 2022. The company plans to present final 6-month BMD data soon and meet with the FDA for future trial discussions.
Entera Bio Ltd. (NASDAQ: ENTX) has announced the appointment of Ron Mayron to its Board of Directors, succeeding Zeev Bronfeld, a long-time board member since 2010. Mayron brings extensive healthcare expertise from previous roles, including CEO of Teva Israel & Africa. Chairman Jerry Lieberman emphasized Mayron's experience in commercializing pharma products, which may bolster Entera's pipeline of oral drug candidates. Entera focuses on developing large molecule therapeutics, with products like EB613 and EB612 in Phase 2 clinical trials.
Entera Bio Ltd. (NASDAQ: ENTX) appointed Ramesh Ratan as U.S. Chief Financial Officer, succeeding Jonathan Lieber. Ratan brings over 40 years of financial and operational experience from various biomedical and tech firms, previously serving as CFO at AOBiome and other companies. His expertise includes raising over $300 million and enhancing strategic alliances. CEO Spiros Jamas praised Ratan's strategic thinking and operational background, noting its potential to strengthen Entera’s management team. The company focuses on developing oral therapeutics for significant medical needs.
Entera Bio Ltd. (NASDAQ: ENTX) announced it will present a poster on the pharmacokinetics of its oral human growth hormone (hGH) formulation at the 31st Annual European Pharma Congress on April 28-29, 2021. This innovative formulation, targeting a market projected to grow from $3.7 billion in 2020 to $8.5 billion by 2027, demonstrated significant gastrointestinal absorption in preclinical studies. CEO Spiros Jamas highlighted the potential advantages of oral delivery, including improved patient compliance and reduced pain associated with injections.
Entera Bio Ltd. (NASDAQ: ENTX) announced significant advancements in its clinical trials and financial results. The FDA approved the Investigational New Drug application for EB613, an oral treatment for osteoporosis, with Phase 2 trial completion in Israel involving 161 subjects. Interim results indicate a positive impact on bone mineral density. Financially, Entera reported revenues of $365,000 for 2020, up from $236,000 in 2019, while operating losses decreased to $11.1 million. The company expects sufficient funding through Q2 2022, highlighting strong collaboration with Amgen and potential future trials.
Entera Bio Ltd. (NASDAQ: ENTX) will report its business and financial results for the year ended December 30, 2020, on March 18, 2021, before U.S. markets open. A conference call with management is scheduled for the same day at 8:30 a.m. EDT, where results will be discussed, followed by a Q&A session. Entera specializes in orally delivered large molecule therapeutics, with key products EB613 and EB612 in Phase 2 clinical trials for osteoporosis and hypoparathyroidism, respectively. The company also collaborates with biopharmaceutical firms, including Amgen.
Entera Bio Ltd. (NASDAQ: ENTX) announced positive results from its Phase 2 clinical trial of EB613, an oral treatment for osteoporosis. The 3-month data indicated a significant increase in the P1NP biomarker (P 0.04), which reflects new bone formation. Secondary endpoints also showed increases in Osteocalcin and decreases in CTX, suggesting potential improvements in bone mineral density (BMD). Overall, EB613 was well tolerated, with no severe adverse events reported. Entera aims to present full 6-month results in Q2 2021.