Welcome to our dedicated page for Entera Bio Ltd. Ordinary Shares news (Ticker: ENTX), a resource for investors and traders seeking the latest updates and insights on Entera Bio Ltd. Ordinary Shares stock.
Entera Bio Ltd. (ENTX) is a biotechnology firm based in Israel, specializing in the development of orally delivered macromolecule therapeutics. These include peptides and therapeutic proteins aimed at treating chronic medical conditions with an unmet need. The company’s innovative approach focuses on oral administration, which has the potential to significantly change treatment paradigms.
Entera Bio's leading product candidates include EB613 and EB612. EB613 is designed to treat osteoporosis in a once-daily, oral mini tablet form of synthetic human PTH (1-34) (teriparatide). It has shown promising results in Phase 2 clinical trials, meeting both primary and secondary endpoints. Entera Bio plans to initiate a Phase 3 study for EB613 in 2024, following FDA guidelines. EB612 is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism.
Beyond these, Entera Bio is advancing several other oral peptide therapies. These include an oral oxyntomodulin tablet for obesity and an oral GLP-2 peptide tablet for rare malabsorption conditions like short bowel syndrome, in collaboration with OPKO Health.
Entera Bio leverages a proprietary technology platform that boosts the oral bioavailability of peptides, making them effective alternatives to injectable therapies. This platform is pivotal in their ongoing projects and future pipeline products, which they aim to bring to clinical phases by 2025.
In terms of financials, Entera Bio has demonstrated robust performance, as reflected in their latest financial results for the year ending December 31, 2023. The company continues to focus on strategic partnerships and advancing their research to fulfill significant unmet medical needs.
For the latest updates and news about Entera Bio Ltd., including their latest product developments and financial results, visit Entera Bio's official website.
Entera Bio Ltd. (NASDAQ: ENTX) has announced the appointment of Dr. Steven R. Goldstein to its Clinical and Scientific Advisory Board. Dr. Goldstein, a prominent figure in menopause research, will play a crucial role in the development of Entera's EB613 program. This innovative therapy aims to provide an oral treatment for post-menopausal osteoporosis, addressing a significant medical need in women's health. The company emphasizes the importance of actively managing bone health for post-menopausal women, especially given the high mortality rates associated with untreated osteoporosis. Entera’s EB613 is designed to be the first oral osteoanabolic therapy, offering hope for improved treatment outcomes.
Entera Bio Ltd. (NASDAQ: ENTX) announced feedback from its Type D Meeting with the FDA regarding its EB613 program for treating postmenopausal osteoporosis. The FDA accepted the use of Total Hip Bone Mineral Density (BMD) as a primary endpoint in a proposed 24-month placebo-controlled Phase 3 trial. They also affirmed the proposed pharmacokinetic study design aligns with FDA expectations. Entera CEO expressed gratitude for the FDA's support, emphasizing the potential of EB613 as the first oral osteoanabolic treatment for millions of women. The company is preparing to advance its EB612 program for hypoparathyroidism into Phase 2 by 2024.
Entera Bio Ltd. (NASDAQ: ENTX) reported its 2022 financial results, indicating significant corporate progress, particularly with its EB613 program aimed at osteoporosis treatment. Total revenues decreased to $134,000 from $571,000 in 2021, resulting in a net loss of $13.1 million, or $0.45 per share. R&D expenses also dropped to $5.8 million, while G&A expenses rose to $7.3 million due to increased compensation. Entera anticipates having sufficient cash of $12.3 million to support operations through Q3 2024 and plans to advance its EB612 program for hypoparathyroidism into Phase 2 in 2024.
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