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 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.
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.