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 the new 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] Leadership Changes - Geno J. Germano brings over three decades of leadership experience in the pharmaceutical and life sciences sectors, having held senior roles at Pfizer, including Group President of Pfizer's Global Innovative Pharmaceutical Business, managing a portfolio worth approximately $14 billion [4] - The CEO of Entera, Miranda Toledano, expressed gratitude for the contributions of the outgoing Chairman and emphasized the importance of Germano's experience in scaling therapeutic platforms [3] Product Development - Entera's lead clinical asset, EB613, is positioned to transform osteoporosis treatment by providing an oral anabolic therapy, which could facilitate earlier intervention in treatment paradigms [3] - The company is also developing other oral peptide therapies, including EB612 for hypoparathyroidism and a dual-targeted GLP-1/glucagon peptide for obesity and metabolic syndromes [5]

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 Viewpoint - OPKO Health and Entera Bio are expanding their collaboration to develop innovative oral peptide therapies, including a long-acting PTH analog for hypoparathyroidism and an oral oxyntomodulin for metabolic disorders, with IND applications expected in late 2026 [3][4][5]. Group 1: Collaboration and Development Programs - The collaboration between OPKO and Entera aims to advance the first oral long-acting PTH analog (LA-PTH) as a once-daily tablet for hypoparathyroidism, with an IND application planned for late 2026 [3][4]. - The companies are also developing an injectable and oral oxyntomodulin (OXM) for metabolic and fibrotic disorders, with initial Phase 1 data from the injectable form expected in late 2026 [1][8]. - Under the expanded collaboration agreement, both companies will hold a 50% ownership interest in the LA-PTH program and share development costs equally, while maintaining a 60%/40% ownership structure for the oral OXM program [5]. Group 2: Key Personnel Changes - Steve Rubin, an industry veteran with extensive experience in corporate governance and drug development, has joined Entera's board of directors, replacing Gerry Ostrov [2][6]. Group 3: Clinical Data and Market Potential - Preclinical data for the oral LA-PTH program suggests it could transform treatment for hypoparathyroidism, which currently relies on daily injections of the only approved PTH replacement therapy [7]. - Entera's previous clinical data for its EB612 program indicated significant reductions in calcium supplement use and maintenance of serum calcium levels, although the regimen required multiple daily doses [7]. - The oral oxyntomodulin is positioned as a dual GLP-1/glucagon agonist with potential benefits for obesity and metabolic disorders, with no approved dual agonists currently available [8].

Core Insights - Entera Bio Ltd. is set to achieve significant milestones in Q1 2026, focusing on the development of oral peptide therapies for osteoporosis and hypoparathyroidism [2][3] Group 1: Corporate Milestones - The company plans to submit its final Phase 3 protocol for EB613 to the FDA in Q1 2026, following a favorable FDA ruling on December 19, 2025 [4] - Results from the Phase 1 bridging study of Next-Gen EB613 are expected by the end of Q1 2026, indicating progress in the development of this next-generation candidate [5] - Entera aims to accelerate its hypoparathyroidism program in 2026, leveraging robust preclinical data for a long-acting PTH analog [6] Group 2: Product Development - EB613 is being developed as the first oral PTH(1-34) anabolic tablet treatment specifically for post-menopausal women with osteoporosis [4][6] - The company is also advancing its EB612 program, which focuses on an oral long-acting PTH(1-34) peptide tablet for patients with hypoparathyroidism [6] - Entera is exploring strategic partnerships to optimize the development and commercialization of its oral peptide programs [6] Group 3: Company Vision - Entera Bio is committed to addressing significant unmet medical needs through innovative oral peptide therapies, aiming to transform the standard of care in various therapeutic areas [7]

Core Insights - Entera Bio Ltd. is set to submit its final Phase 3 protocol for EB613 to the FDA in Q1 2026, following a favorable ruling in December 2025 [1][3] - The company is advancing its Next-Generation EB613 Phase 1 bridging study, with results anticipated by the end of Q1 2026 [1][4] - Entera is accelerating its oral hypoparathyroidism tablet program with long-acting PTH variants and is engaged in strategic partnership discussions to enhance its pipeline [1][5] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies for significant unmet medical needs, utilizing its proprietary N-Tab™ technology [6] - The company's lead product, EB613, is an oral PTH(1-34) anabolic tablet aimed at post-menopausal women with osteoporosis, having met primary and secondary endpoints in a Phase 2 study [6] - Entera is also developing EB612, an oral long-acting PTH(1-34) peptide tablet for hypoparathyroidism, and other oral peptide therapies targeting obesity and rare malabsorption conditions [6]

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. has received FDA qualification for total hip bone mineral density (BMD) as a validated regulatory endpoint for osteoporosis drug development, which supports the company's strategy for its product EB613 [1][2] - The FDA's position may simplify the regulatory pathway for Entera, allowing a single Phase 3 study with total hip BMD as the primary endpoint to support a New Drug Application (NDA) for EB613 [2] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, aiming to transform the standard of care for significant unmet medical needs [7] - The company's lead product candidate, 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] Industry Context - Osteoporosis affects over 200 million women globally, with a significant number remaining undertreated; no new osteoporosis drug has been approved by the FDA since 2019 [2][5] - Osteoporosis is a major public health issue, leading to over 2 million fractures annually in the US, with projected medical costs for osteoporotic fractures expected to rise from $57 billion in 2018 to $95 billion by 2040 [5] 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 novel treatment option [4] - The development of validated surrogate endpoints like BMD may facilitate faster drug development and address the ethical challenges associated with osteoporosis clinical trials [6]

Core Insights - Entera Bio Ltd. announced new in vivo pharmacokinetic and pharmacodynamic data supporting the development of a long-acting parathyroid hormone (PTH) analog for hypoparathyroidism, aiming to create the first once-daily tablet treatment [1][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab® platform to address significant unmet medical needs [7] - The company is advancing multiple programs, including EB612 for hypoparathyroidism and EB613 for osteoporosis, with a goal of transforming the standard of care through oral formulations [7] Product Development - The EB612 program aims to provide a single, once-daily PTH tablet, addressing the dosing burden associated with current treatments that require daily or weekly injections [3][4] - Recent preclinical findings showed that the proprietary PTH analog achieved a significantly longer plasma half-life and sustained calcium elevation for over three days, compared to unmodified PTH(1-34) controls, which did not elicit a calcium response [1][9] Clinical Evidence - A previous Phase 2 study demonstrated a 42% reduction in median calcium supplement use while maintaining serum calcium levels above the lower limit for hypoparathyroidism patients, although it involved a four-times-a-day dosing regimen [3] - The recent minipig study confirmed the pharmacokinetic and pharmacodynamic profile of the new PTH analog, supporting its potential for once-daily dosing [5][9] Future Plans - Entera plans to present the new data at an upcoming medical conference, indicating ongoing commitment to advancing its clinical programs [6]

Core Insights - Entera Bio Ltd. announced new in vivo pharmacokinetic and pharmacodynamic data supporting the development of a long-acting parathyroid hormone (PTH) analog for hypoparathyroidism, which could lead to a once-daily oral tablet treatment [1][4] Group 1: Product Development - The proprietary PTH analog achieved sustained calcium elevation for over three days from a single oral tablet, contrasting with unmodified PTH(1-34) controls that showed no calcium response [1][8] - Entera's previous Phase 2 study demonstrated a 42% reduction in median calcium supplement use while maintaining serum calcium levels above the lower limit for hypoparathyroidism patients [3] - The current preclinical data represent a significant advancement towards a single, once-daily tablet, addressing the dosing burden of existing treatments [3][5] Group 2: Market Context - Hypoparathyroidism is a rare endocrine disorder characterized by deficient PTH production, leading to hypocalcemia and hyperphosphatemia, with current treatments requiring daily or weekly injections [2] - The only approved PTH replacement treatment requires daily injections, highlighting the need for more convenient alternatives [2] Group 3: Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab platform [7] - The company is also developing other oral peptide programs targeting conditions such as osteoporosis and obesity, indicating a broad pipeline aimed at significant unmet medical needs [7]