Entera Bio Ltd. Ordinary Shares - ENTX STOCK NEWS

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.