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) 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.
Entera Bio Ltd (NASDAQ: ENTX) will report its business and financial results for Q1 2022 on May 12, 2022, at 8:30 AM EDT. The company focuses on developing orally delivered large-molecule therapeutics to address significant unmet medical needs. Entera's advanced candidates include EB613 for osteoporosis and EB612 for hypoparathyroidism, which are currently in clinical development. The company also collaborates with biopharmaceutical firms, including Amgen Inc., licensing its proprietary drug delivery technology.
Entera Bio Ltd (NASDAQ: ENTX), a pioneer in orally delivered large molecule therapeutics, announced its participation in the Maxim Virtual Growth Conference on March 30, 2022, at 10:30 AM EDT, featuring a fireside chat format.
Following the event, a webcast replay will be accessible on Entera's investor relations website. Entera focuses on addressing unmet medical needs with its cutting-edge oral drug delivery technology, particularly for osteoporosis and hypoparathyroidism. The company recently completed a phase 2 study for its lead candidate, EB613.
Entera Bio Ltd. (NASDAQ: ENTX) reported 2021 financial results, highlighting a revenue increase to $571,000 from $365,000 in 2020. The company incurred an operating loss of $12.2 million, up from $11.2 million the previous year. Key developments include positive Phase 2 results for EB613 in osteoporosis and EB612 for hypoparathyroidism. Entera plans to initiate Phase 3 trials for EB613 and a new formulation for EB612 in 2022. The company holds $24.9 million in cash as of year-end, projecting an operating loss of $25-$30 million for 2022.
Entera Bio Ltd (NASDAQ: ENTX) will report its financial and business results for the year ended December 31, 2021, on March 8, 2022, at 6:30 AM EST. Following the results, a conference call will be held at 8:30 AM EST, where management will discuss the findings and take questions from participants. The company specializes in orally delivered large molecule therapeutics, focusing on conditions with significant unmet medical needs. Its lead candidates are EB613 for osteoporosis and EB612 for hypoparathyroidism, currently in clinical development.
Entera Bio Ltd (NASDAQ: ENTX) announced that CEO Spiros Jamas, Sc.D., will present a company overview at the Aegis Capital Corp. Virtual Conference on February 23, 2022, at 3:30 PM Eastern. The presentation will detail the pivotal Phase 3 study for its lead drug candidate, EB613, aimed at being the first oral bone-building drug for osteoporosis. More details here.