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) 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.
Entera Bio Ltd. (NASDAQ: ENTX) announced participation in the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. CEO Spiros Jamas will present an overview of the company’s business during this virtual event. A webcast of the presentation will be available on Entera's website starting March 9 at 7 a.m. ET. Entera is focused on developing orally delivered large molecule therapeutics, with key products like EB613 and EB612 in Phase 2 clinical development.
Entera Bio Ltd. (NASDAQ: ENTX) announced the publication of its Phase 2a study results for EB612 in the Journal of Bone and Mineral Research. The study demonstrated a 42% reduction in calcium supplement use (p=0.001) among patients with hypoparathyroidism. Significant improvements included maintenance of serum calcium levels, a 23% decrease in serum phosphate (p=0.0003), and a 5% increase in quality of life scores (p=0.03). The trial involved 19 patients, with 17 completing it without serious adverse events. Entera plans to enhance EB612 formulations and start a new trial in 2022.
Entera Bio Ltd. (NASDAQ: ENTX) has initiated a research program to develop an oral GLP-2 analog using its proprietary platform technology. This move aims to provide an alternative to the current injectable treatment for short bowel syndrome, teduglutide, which generated $574 million in sales in 2019. The company believes GLP-2 analogs could address various metabolic diseases, enhancing patient compliance and reducing costs. Entera's technology has significant potential in the oral delivery of large molecules, aligning with a growing market for biologics valued at $20 billion annually.
Entera Bio Ltd. (NASDAQ: ENTX) announced a Letter to Shareholders from newly appointed CEO Spiros Jamas, emphasizing the company's progress in developing orally delivered therapeutics. They bolstered their balance sheet with $8.6 million in cash, funding clinical programs into Q3 2021. Key highlights include FDA approval for their oral osteoporosis drug, EB613, and positive interim data from clinical trials. The potential market for EB613 is projected to grow to $20 billion if successful. The company also reported positive results for EB612, an oral treatment for hypoparathyroidism, meeting all trial endpoints.
Entera Bio Ltd. (NASDAQ: ENTX) has received FDA approval to proceed with the initial U.S. clinical trial for EB613, an orally delivered human parathyroid hormone (1-34) aimed at treating osteoporosis. This positions EB613 as a pioneering once-daily oral treatment for osteoporosis patients. The ongoing Phase 2 trial's biomarker data is expected in Q1 2021, with final bone mineral density results anticipated in Q2 2021. The company aims for a pivotal Phase 3 trial post-analysis, highlighting the unmet need for oral PTH therapies.
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