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.
Entera Bio Ltd. (NASDAQ: ENTX) will host a webinar on September 28, 2022, discussing its lead asset EB613 and its potential for osteoporosis treatment. The event features esteemed KOLs from Columbia University and Mayo Clinic, who will examine the current osteoporosis landscape and unmet needs in post-menopausal women. Entera will present Phase 2 data on EB613, a proprietary oral formulation of teriparatide, and outline its proposed Phase 3 plan submitted to the FDA. The webinar will also include a live Q&A session.
Entera Bio Ltd. (NASDAQ: ENTX) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 3:30 PM ET. The company's CEO, Miranda Toledano, will present and hold one-on-one meetings during the event. Entera specializes in developing orally delivered peptides and therapeutic proteins, focusing on addressing unmet medical needs where injectable therapies face challenges. Their advanced products include EB613 for osteoporosis and EB612 for hypoparathyroidism, with a Phase 2 study recently completed for EB613.
Entera Bio Ltd. (NASDAQ: ENTX) announced a key poster presentation at the ASBMR Annual Meeting 2022 for its Phase 2 study of EB613 (EBP05), an oral formulation of PTH for postmenopausal women with low bone mass. This study demonstrated significant correlations between EB613 dosages and blood levels, achieving primary and secondary endpoints, specifically in lumbar spine BMD after 6 months. The findings suggest EB613's potential as a convenient treatment option in osteoanabolic therapy, positioning it as a competitor to existing injectable treatments.
Entera Bio Ltd. (NASDAQ: ENTX) reported its financial results for the quarter ending June 30, 2022, showing revenues of $112,000, down from $226,000 in 2021. The company experienced an operating loss of $7.1 million and a net loss of $6.97 million, compared to $4.9 million in the same period last year. Entera holds $17.3 million in cash, sufficient to fund operations until mid-2023. Notably, the company submitted a protocol for EB613 to the FDA and is developing an optimized formulation of EB612, which may reduce administration frequency. The clinical pipeline expansion continues with new anti-inflammatory candidates.
Entera Bio Ltd. (NASDAQ: ENTX) announced the formation of a Clinical and Scientific Advisory Board (CSAB) comprised of experts in bone diseases and metabolic disorders. The company will present new data from its Phase 2 study of Oral PTH (EB613) at the ASBMR National Meeting on September 11, 2022, in Austin, Texas. The study showed significant increases in bone mineral density, particularly in postmenopausal women. CEO Miranda Toledano emphasized the importance of the CSAB's expertise in advancing Entera's clinical development strategy.
Entera Bio Ltd. (NASDAQ: ENTX) has achieved significant milestones in the development of its oral drug, EB613, for osteoporosis treatment. The FDA approved a Type C Meeting request to discuss the revised Phase 3 study, allowing for an 18-month double-blind trial aimed at assessing Bone Mineral Density (BMD) as a surrogate endpoint. The pivotal study is designed to facilitate potential approval without a fracture study. Additionally, Miranda Toledano has been appointed CEO, succeeding Dr. Spiros Jamas, to lead Entera’s strategic reorientation in pivotal clinical development.
Entera Bio Ltd. (NASDAQ: ENTX) announced the resignation of Dr. Phillip Schwartz, President of Research & Development and co-founder, effective July 21, 2022. Dr. Schwartz, who also stepped down from the Board on June 15, 2022, will continue as a consultant. He emphasized his confidence in the new management team and provided insights on Entera's pivotal drug candidates, EB613 for osteoporosis and EB612 for hypoparathyroidism, currently in clinical development. Entera aims to leverage its proprietary oral delivery technology to address significant unmet medical needs in these areas.
Entera Bio Ltd. (NASDAQ: ENTX) appointed Miranda Toledano as Chief Business Officer, Chief Financial Officer, and Head of Corporate Strategy, effective immediately. Toledano, a board member since 2018, brings nearly 25 years of experience in biotechnology and finance. Her leadership will be crucial as Entera advances its lead program, EB613, aimed at treating osteoporosis in post-menopausal women. The company aims to expand its oral delivery platform for therapeutics while collaborating with strategic partners.
Entera Bio Ltd. (NASDAQ: ENTX) has commenced the registrational study design for its lead clinical asset, EB613, an oral treatment for post-menopausal women at high risk of osteoporosis. The FDA has completed its review of the Chemistry Manufacturing and Control for EB613, paving the way for a pivotal Phase 3 trial. Financially, Entera reported a revenue drop to $68,000 for Q1 2022, down from $157,000 in Q1 2021, while operating expenses rose to $3.8 million, leading to a net loss of $3.8 million, or $0.13 per share. The company has cash reserves of $20.1 million as of March 31, 2022.
Entera Bio Ltd (NASDAQ: ENTX) announced the filing of multiple U.S. patent applications to bolster its intellectual property and support future development of its oral delivery platform technology. This technology aims to enhance bioavailability and reduce drug costs compared to existing oral delivery systems for peptides. Additionally, the company is focusing on specific molecules, such as parathyroid hormone and glucagon-like peptides, for various therapeutic indications. CEO Spiros Jamas highlighted the potential for strategic partnerships to advance their innovations.