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. (NASDAQ: ENTX) generates a steady flow of news as a clinical-stage biopharmaceutical company developing oral peptide and protein replacement therapies. News coverage on this page focuses on the company’s progress with its proprietary N-Tab™ oral peptide platform and its pipeline of tablet-based biologic candidates.
Investors and followers of ENTX can use this news feed to track key developments around EB613, Entera Bio’s lead oral PTH(1-34) (teriparatide) osteoanabolic tablet for postmenopausal women with osteoporosis or low bone mineral density. Updates often include Phase 2 clinical data, post-hoc analyses of bone mineral density outcomes, presentations at bone and endocrine conferences, and regulatory milestones such as FDA alignment on Phase 3 trial design and acceptance of total hip BMD as a primary endpoint.
The news stream also highlights progress in the EB612 program for hypoparathyroidism, including preclinical pharmacokinetic and pharmacodynamic data for a proprietary long-acting PTH analog formulated as a once-daily oral tablet. Coverage extends to Entera Bio’s collaboration with OPKO Health on oral GLP-2 and oxyntomodulin tablet candidates, with reports on preclinical data for short bowel syndrome and obesity programs presented at international nutrition and endocrine meetings.
In addition, readers will find quarterly financial results, business updates, participation in healthcare and investor conferences, and commentary from company leadership on strategy and clinical priorities. This page brings together ENTX press releases and related announcements so that investors, clinicians and other stakeholders can follow the company’s clinical, regulatory and collaboration milestones in one place.
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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.
Entera Bio Ltd. (NASDAQ: ENTX) announced on March 23, 2023, that it has regained compliance with NASDAQ's minimum bid price requirement. This follows a previous notification from NASDAQ on November 21, 2022, when the company failed to maintain a minimum bid price of $1.00 per share for 30 consecutive business days. Entera's ordinary shares have closed at $1.00 or higher for the last 14 consecutive business days, thus resolving the compliance issue. The company remains listed on The NASDAQ Capital Market and adheres to all applicable listing standards.