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 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.
Entera Bio Ltd. (NASDAQ: ENTX) has appointed Spiros Jamas as its new CEO effective January 4, 2021, succeeding interim CEO Dr. Roger Garceau. Dr. Jamas brings over 30 years of biopharmaceutical experience, aiming to advance Entera’s osteoporosis treatment EB613 and hypoparathyroidism treatment EB612, both in Phase 2 trials. The company anticipates key data readouts in the first half of 2021, presenting potential growth opportunities. Shareholder approval is required for Dr. Jamas' engagement terms.
Entera Bio Ltd. (NASDAQ: ENTX) announced the completion of enrollment in its Phase 2 clinical trial of EB613, aimed at treating osteoporosis. A total of 161 subjects were randomized, with interim data showing a 2.15% mean increase in lumbar spine bone mineral density (BMD) compared to placebo. The company plans to report additional biomarker data in Q1 and Q2 of 2021. Financially, Entera reported revenues of $144,000 for the nine months ended September 30, 2020, alongside an operating loss of $(8.8) million and a net loss of $(7.7) million. Cash reserves stood at $7.1 million as of September 30, 2020.