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) 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.
On August 23, 2021, Entera Bio Ltd. (NASDAQ: ENTX) announced its upcoming annual shareholders meeting scheduled for October 4, 2021. Entera is focused on developing orally delivered large molecule therapeutics to address unmet medical needs in areas where injectable therapies face adoption challenges. Its leading candidates, EB613 for osteoporosis and EB612 for hypoparathyroidism, are currently in clinical development. The company also collaborates with Amgen Inc. to leverage its proprietary oral delivery technology.
Entera Bio Ltd. (NASDAQ: ENTX) announced that CEO Spiros Jamas will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 3:30 pm ET. The conference runs from September 13-15, 2021, in New York. Entera focuses on innovative oral delivery systems for large molecule therapeutics, addressing significant unmet medical needs. Their lead candidates include EB613 for osteoporosis and EB612 for hypoparathyroidism, currently in clinical development. The company also collaborates with biopharma firms, including Amgen.
Entera Bio Ltd. (NASDAQ: ENTX) announced positive results from its Phase 2 clinical trial of EB613, an oral therapy for osteoporosis, achieving primary and key secondary endpoints. The trial demonstrated a 3.78% increase in lumbar spine bone mineral density after six months. The company is preparing for an End of Phase 2 meeting with the FDA to advance to a pivotal Phase 3 study, expected to start in Q2 2022. Financially, Entera reported $266,000 in revenue for the first half of 2021, with a net comprehensive loss of $14.6 million, or $0.63 per share.
Entera Bio Ltd. (NASDAQ: ENTX) will report its business and financial results for Q2 2021 on August 16, 2021, at 6:30 AM ET. A conference call led by management will follow at 8:30 AM EDT, allowing stakeholders to engage in a Q&A session. Entera is focused on developing orally delivered large molecule therapeutics, particularly EB613 for osteoporosis and EB612 for hypoparathyroidism, which are currently in clinical development. The company has completed a phase 2 study for EB613 and collaborates with Amgen for technology licensing.
Entera Bio Ltd. (NASDAQ: ENTX) announced that its Phase 2 clinical trial for oral EB613, aimed at treating osteoporosis, met its primary endpoint by significantly increasing P1NP, a bone formation marker, at three months. This positions EB613 as a potential first oral anabolic agent for osteoporosis, addressing the unmet need for injectable alternatives like Forteo®. Full three-month data will be presented at the ASBMR Annual Meeting in October. Entera plans to initiate a pivotal Phase 3 trial against Forteo in 2022, highlighting the promising outlook for EB613.