TEL AVIV, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide and protein replacement therapies, today announced that the Company’s Chief Executive Officer, Miranda Toledano, will be participating in a fireside chat at the Leerink Partners Global Healthcare Conference 2026, details as below. Leerink Partners Global Healthcare Conference 2026 (Fireside Chat and 1x1 Meetings) Date and Time: March 11, 2026 at 10:40 a.m. Easte ...

Core Viewpoint - Entera Bio Ltd. has announced that several members of its Board of Directors, including the Chairman, have made open market purchases of the Company's ordinary shares, indicating confidence in the Company's future prospects [1][2]. Group 1: Board Purchases - The purchases were made by Geno J. Germano (Chairman), Steven D. Rubin, Haya Taitel, and Sean Ellis, all Directors of the Company [2]. - These transactions were conducted at prevailing market prices and are reported in filings with the U.S. Securities and Exchange Commission [2]. Group 2: Company Overview - Entera Bio is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs [4]. - The Company utilizes a proprietary technology platform (N-Tab®) and has a pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1, and GLP-2 [4]. - The most advanced product candidate, EB613, is being developed as the first oral osteoanabolic treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis [4]. - A Phase 2 study of EB613 met primary and secondary endpoints, demonstrating its potential effectiveness [4]. - Entera is also developing the first oral oxyntomodulin for obesity and metabolic syndromes, and the first oral GLP-2 peptide for rare malabsorption conditions in collaboration with OPKO Health [4].

Core Insights - Entera Bio Ltd. has appointed Geno J. Germano as Chairman of the Board, effective February 4, 2026, succeeding Gerald Lieberman [1] - The company is advancing two oral PTH peptide programs into clinical testing in 2026, including a Phase 3 study for EB613 in osteoporosis and a first-in-human study for Long-Acting Oral PTH in hypoparathyroidism [2] Company Developments - Entera's lead clinical asset, EB613, is positioned to transform osteoporosis treatment by providing an oral anabolic therapy, which could broaden its use among patients [3] - The company has established a foundation for its oral peptide pipeline and is transitioning to late-stage clinical testing, with Germano's leadership expected to enhance its development and commercialization efforts [3][4] Leadership Background - Geno J. Germano brings over 30 years of experience in the pharmaceutical and life sciences sectors, having held senior roles at Pfizer, including leading a $14 billion innovative medicines portfolio [4] - Germano's previous board experience includes roles at various biotechnology companies, indicating a strong background in guiding clinical-stage firms [4] Product Pipeline - Entera is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab® technology platform [5] - The company's most advanced product, EB613, is being developed as the first oral treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis [5] - Additional programs include an oral PTH(1-34) tablet for hypoparathyroidism and an oral oxyntomodulin for obesity and metabolic syndromes [5]

Core Insights - Entera Bio Ltd. has received FDA qualification for total hip bone mineral density (BMD) as a validated regulatory endpoint for osteoporosis drug development, which supports its regulatory strategy for EB613 [1][2] - The company aims to democratize anabolic treatment for osteoporosis, addressing the significant unmet medical needs of over 200 million women globally who are estimated to have osteoporosis [2][5] Company Overview - Entera is a clinical-stage company focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [7] - The company's lead product, EB613, is being developed as the first oral, once-daily anabolic tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis [4][7] Product Development - EB613 has shown efficacy in a Phase 2 study, meeting all biomarker and BMD endpoints without significant safety concerns, indicating its potential as a transformative treatment option [4] - The FDA's broad qualification of total hip BMD may simplify the regulatory pathway for EB613, allowing for a single Phase 3 study to support a New Drug Application (NDA) [2][3] Industry Context - Osteoporosis is a major public health issue, responsible for over 2 million fractures annually in the US, with significant medical costs projected to rise from $57 billion in 2018 to $95 billion by 2040 [5] - The aging population is expected to increase the incidence of osteoporosis-related fractures, highlighting the need for novel products with enhanced efficacy and ease of use [6]

Core Insights - Entera Bio Ltd. is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs, utilizing its proprietary N-Tab™ technology platform [3] Company Overview - Entera Bio is developing first-in-class oral peptide programs targeting PTH(1-34), GLP-1, and GLP-2, with its most advanced product candidate, EB613, aimed at treating post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [3] - The company has successfully completed a placebo-controlled, dose-ranging Phase 2 study of EB613 tablets, which met both primary and secondary endpoints [3] - Other product candidates include EB612 for hypoparathyroidism and an oral oxyntomodulin for obesity and metabolic syndromes, as well as an oral GLP-2 peptide for rare malabsorption conditions in collaboration with OPKO Health [3] Upcoming Events - The CEO of Entera Bio, Miranda Toledano, will participate in a fireside chat at the 8th Annual Evercore ISI Healthcare Conference on December 3, 2024, in Coral Gables, Florida [2]

Core Insights - Entera Bio Ltd. will present new clinical data from its Phase 2 trial of EB613 at the North American Menopause Society (NAMS) 2025 Annual Meeting, marking its first presentation at this event [1][2] - The presentation will focus on bone mineral density outcomes in early postmenopausal women with low bone mass or osteoporosis, highlighting the potential role of EB613 in earlier treatment stages [2][3] Company Overview - Entera Bio is a clinical stage company developing oral peptide and protein replacement therapies, aiming to transform the standard of care for significant unmet medical needs [6] - The company's lead product candidate, EB613, is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis, specifically targeting postmenopausal women with low bone mass [5][6] Product Details - EB613 has shown efficacy in a Phase 2, 6-month, placebo-controlled study involving 161 patients, meeting all biomarker and bone mineral density endpoints without significant safety concerns [5] - The treatment produced rapid increases in biochemical markers of bone formation and reductions in markers of bone resorption, along with increased bone mineral density in key areas [5] Market Context - Anabolic therapies for osteoporosis are underutilized, primarily due to their availability only as injections, which limits access for many eligible patients [3][5] - Entera Bio's oral formulation of EB613 has the potential to broaden access for over 200 million women worldwide living with osteoporosis, addressing a critical gap in treatment options [3][5]

Core Viewpoint - Entera Bio Ltd. has received FDA agreement to support the NDA marketing application filing for EB613 based on a single 24-month phase 3 study, marking a significant regulatory milestone for the company and the osteoporosis community [1][2] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company's lead product candidate, EB613, is an oral anabolic treatment for post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [5] Product Development - EB613 is designed as the first oral, once-daily anabolic tablet treatment for osteoporosis, aiming to increase skeletal mass, improve bone microarchitecture, and reduce fracture risk [3][4] - A phase 2 study of EB613 demonstrated significant efficacy, meeting all biomarker and BMD endpoints without major safety concerns [4] Regulatory Context - The FDA's agreement allows Entera to advance its clinical development program without waiting for the qualification of the SABRE initiative, which aims to establish BMD as a regulatory endpoint [2][6] - The SABRE initiative has shown that treatment-related gains in total-hip BMD can predict fracture-risk reduction, with a correlation coefficient of 0.73 [6] Market Need - Osteoporosis affects over 200 million women globally, with a significant portion remaining undertreated despite available injectable treatments [3] - The lack of new FDA-approved osteoporosis drugs since 2019 highlights the urgent need for innovative treatments like EB613 [3]

Core Insights - Entera Bio Ltd. is advancing EB613, an oral anabolic treatment for postmenopausal women with osteoporosis, which has been selected for presentation at the ASBMR 2025 Annual Meeting [1][4] - EB613 is designed to be the first once-daily oral PTH(1-34) tablet, aiming to provide a viable treatment option for patients at high risk of fractures [2][4] - The Phase 2 study demonstrated significant increases in bone mineral density (BMD) across all measured skeletal sites compared to baseline and placebo [2][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company is preparing to initiate a Phase 3 registrational study for EB613 following FDA qualification of a quantitative BMD endpoint [5] - Entera's pipeline includes other innovative oral therapies targeting conditions such as hypoparathyroidism and obesity [5] Industry Context - Osteoporosis is a significant health concern, affecting approximately 200 million women globally, with a high risk of fragility fractures in older adults [3] - The current injectable anabolic treatments are not suitable for many patients, highlighting the need for oral alternatives like EB613 [4]