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 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.
Entera Bio Ltd (NASDAQ: ENTX) announced plans to initiate a multi-national Phase 3 trial in 2022 for EB613, an oral formulation of human parathyroid hormone aimed at treating osteoporosis. Following a successful End-of-Phase 2 meeting with the FDA, the company confirmed that a fracture study is not required, with lumbar spine BMD at 12 months as the primary endpoint. If approved, EB613 would become the first oral anabolic osteoporosis treatment, potentially expanding patient access. With over 200 million osteoporosis patients globally, Entera anticipates significant market growth.
Entera Bio Ltd. (NASDAQ: ENTX) announced its financial results for Q3 2021, revealing revenues of $406,000, significantly up from $144,000 in Q3 2020. The Phase 2 clinical trial for EB613 showed promising results in increasing bone mineral density in osteoporosis patients, leading to plans for a Phase 3 trial in 2022. The company has a strong cash position of $27.4 million, which supports its operations through Q4 2022. Additionally, operating expenses decreased, but the net comprehensive loss widened to $17.1 million, up from $7.7 million in the same period last year.
Entera Bio Ltd. (NASDAQ: ENTX) announced promising results from preclinical in vivo studies showcasing its proprietary oral delivery technology, which demonstrates enhanced absorption for large biologic drugs. This technology underpins Entera's lead product, EB613, currently in Phase 3 clinical development for osteoporosis, with a pivotal study set for 2022. Researchers reported a significant increase in blood PTH levels using a dual mechanism combining protease inhibitors and permeation enhancers, making oral dosing a viable alternative to injections, which may improve patient compliance and treatment outcomes.
Entera Bio Ltd. (NASDAQ: ENTX) announced positive results from its completed Phase 2 trial of EB613, an oral formulation of human parathyroid hormone (PTH) aimed at treating osteoporosis. Key findings showed a significant placebo-adjusted increase of 3.78% in lumbar spine bone mineral density (BMD) after six months of treatment with the 2.5 mg dosage. Additionally, increases in BMD at the femoral neck and total hip were noted. The pivotal Phase 3 registration study is expected to commence in 2022. The safety profile was consistent with injectable PTH, with no serious adverse events reported.
Entera Bio Ltd. (NASDAQ: ENTX) announced its selection for a late-breaking oral presentation at the ASBMR Annual Meeting, showcasing results from its Phase 2 study on EB613 for treating osteoporosis in postmenopausal women. The presentation will highlight the 6-month bone mineral density (BMD) results, confirming dose-related efficacy. Scheduled for October 4, 2021, this position aims to attract interest from potential clinical investigators and prescribers. Entera is gearing up for a pivotal Phase 3 study, as CEO Spiros Jamas noted positive peer reviews enhancing the presentation's significance.