ENTX

EB613, the first oral anabolic (bone building) peptide tablet for postmenopausal women with osteoporosis – Phase 3 protocol submitted with FDA feedback expected imminently; incremental data submitted to ENDO2026 and ASBMR EB612, the first oral long-acting PTH peptide replacement tablet for hypoparathyroidism – Expanded 50/50 partnership with OPKO; intention to file IND in late 2026; data submitted to ENDO2026 EB618, the first oral OXM (dual GLP-1/Glucagon) tablet for metabolic and fibrotic conditions – data submitted to ENDO2026 Direct Investment led by BVF Partners L.P. to support EB613 pivotal study acceleration and working capital TEL AVIV, May 08, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today reported financial results and key business updates for the quarter ended March 31, 2026. “The first quarter of 2026 solidified Entera’s position as the leading oral peptide therapeutics company. Our N-Tab® platform is developing arguably the richest pipeline of clinical and near-clinical first in class assets, and we are driven by our mission to develop transformative medicines and invest in therapeutic spaces that have been ignored and require urgent attention,” said Miranda Toledano, CEO of Entera. “This begins with our EB613 journey to develop the first oral anabolic to potentially help millions of women preserve their bone health while advocating for much needed innovation in a therapeutic space which disproportionately affects the health of women. In March 2026, we submitted documents to FDA related to EB613’s potential registrational package. This quarter, we also completed a critical Phase 1 bridging study for the single, final tablet formulation of EB613. Additionally, we submitted PK and TPTX proof of concept data for EB612 in hypoparathyroidism and NHP PK data for EB618 in metabolic conditions to ENDO2026 and ASBMR. Each of these milestones has been executed with a strong focus on capital efficiency by a core team that has a unifying commitment to succeed in developing therapeutics that matter,” said Miranda Toledano, Chief Executive Officer of Entera. Key Recent Highlights EB613: First Oral PTH(1-34) Anabolic Tablet for Osteoporosis Streamlined Phase 3 Protocol Submitted to FDA: In March 2026, Entera announced it had submitted a clinical amendment to the FDA provid...

EB613, the first oral anabolic (bone building) peptide tablet for postmenopausal women with osteoporosis – FDA Type A endpoint alignment in July 2025, Phase 3 protocol submitted to the FDA with comments expected in early Q2 2026 EB612, the first long-acting oral PTH peptide replacement tablet for patients with hypoparathyroidism - final variants selected, pre-IND initiatives underway with intention to file IND in late 2026 in partnership with OPKO EB618, the first Oral OXM (GLP-1/Glucagon) peptide tablet for patients with metabolic syndromes – PK/PD validation complete, intention to file IND pursuant to OPKO Phase 1 SAD/MAD SC injection data TEL AVIV, March 27, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today reported financial results and key business updates for the year ended December 31, 2025. "2025 was a landmark year for Entera, our EB613 program and for the osteoporosis community as a whole. We are eager to initiate our important phase 3 study for EB613 and thank the investigator and patient community for their enthusiasm to take part in this mission. While current injectable anabolic or bone forming agents are accepted or accessed by a minority of osteoporosis patients in whom they should be used, our mission with EB613 is to democratize anabolic treatment. EB613 is being developed as the first oral bone building tablet so potentially, every woman and man can have the opportunity to protect their bones whether they are being treated with a primary care practitioner or a specialist,” said Miranda Toledano, Chief Executive Officer of Entera. “Throughout 2025, we also met every milestone relating to our pipeline and advanced each program with the utmost capital efficiency. Our N-Tab® oral peptide platform delivered differentiated preclinical data on LA-PTH, GLP-1/Glucagon and GLP-2 targets in partnership with OPKO Health, Inc. (“OPKO”). We believe these assets will further drive value for patients with hypoparathyroidism, metabolic syndromes and rare gastrointestinal chronic conditions.” Key Recent Highlights EB613: First Oral PTH(1-34) Anabolic Tablet for Osteoporosis Streamlined Phase 3 Protocol Submitted to FDA: In March 2026, Entera submitted a clinical amendment to the FDA providing a streamlined Phase 3 protocol, statistical analysis plan, and open-label extens...

FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study EB613 Phase 2 Data Demonstrating Consistent Efficacy across Younger Post-Menopausal Women with Osteoporosis and its Impact on Trabecular and Cortical Bone Indices, Highlighted at NAMS and ASBMR Next-Generation EB613 Remains on Track for Phase 1 Initiation in Late 2025 Pre-Clinical Data for Oral OXM in Obesity and Oral GLP-2 in Short Bowel Syndrome in Collaboration with OPKO Presented at ENDO2025 and ESPEN JERUSALEM, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptide and protein replacement therapies, today reported financial results and key business updates for the quarter ended September 30, 2025. “Our achievements this quarter are testament to Entera’s leadership position in oral peptide innovation and our team’s unrelenting mission to deliver transformative treatments to patients, starting with post-menopausal women with osteoporosis,” said Miranda Toledano, Chief Executive Officer of Entera. “Our FDA agreement for EB613 this July is unprecedented and underscores the strength of our data and the promise for EB613 to close the treatment chasm in osteoporosis, a disease which disproportionately afflicts women and remains grossly undertreated globally. EB613 data continues to be highlighted across major medical conferences focused on advancing novel treatments in bone metabolism, endrocrine and women’s health, while our N-Tab™ platform consistently delivered across pipeline programs, including our oral GLP-2 program for short bowel syndrome and our oral OXM program in metabolic diseases in partnership with OPKO Health (“OPKO”).” Key Recent Highlights EB613: First Oral PTH(1-34) Anabolic Tablet Treatment for Osteoporosis FDA Agreement on BMD as Primary Endpoint: In a written response to a Type A meeting, the FDA agreed with Entera’s proposal that a single multinational, randomized, double-blind, placebo-controlled, 24-month Phase 3 study where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures as the key secondary endpoint, would support an NDA marketing application for EB613. Strong Phase 2 Data Reinforce Early Onset of EB613 Anabolism: At the ASBMR 2025 Annual Meeting, Entera presented post-hoc 3D-DXA results showing significant...

Explore Entera Bio's Fair Values from the Community and select yours Net loss: US$2.66m (loss widened by 24% from 2Q 2024). US$0.057 loss per share. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. All figures shown in the chart above are for the trailing 12 month (TTM) period Entera Bio shares are down 13% from a week ago. You should learn about the 3 warning signs we've spotted with Entera Bio (including 1 which is a bit unpleasant). Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

FDA provides pivotal agreement on EB613 Phase 3 design, confirming Bone Mineral Density (BMD) as primary endpoint and clearing streamlined pathway for first oral anabolic osteoporosis treatment Significant regulatory and pipeline advancements achieved including FDA waiver of additional safety studies and next-gen EB613 expected to enter Phase 1 in November 2025 Strong momentum across OPKO collaboration with obesity program showing promising preclinical data; and EB612 oral PTH directed hypoparathyroidism program candidate validation Strong balance sheet provides runway through mid-Q3 2026, including dedicated OPKO collaboration funding JERUSALEM, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptide and protein replacement therapies, today reported financial results and key business updates for the quarter ended June 30, 2025. "Last week's FDA agreement on using BMD as the primary endpoint for EB613's Phase 3 program represents a pivotal milestone in our journey to bring the first oral anabolic osteoporosis tablet treatment to market," said Miranda Toledano, Chief Executive Officer of Entera. "This unprecedented regulatory alignment validates both the strength of our clinical data and our strategic vision that began taking shape in July 2022. The concurrence opens the door to addressing a massive unmet need - with less than 25% of the world's 200 million osteoporotic women having access to safe, effective, and affordable treatment options, and no new therapies approved in this space since 2019. Beyond EB613, throughout Q2, we continued building momentum across our entire pipeline, including presenting promising pharmacokinetic data for our oral GLP-1/glucagon dual agonist program with OPKO. With our strengthened cash position of $18.9 million, including dedicated OPKO collaboration funding, we are well-positioned to execute on multiple value-creating milestones across 2025 and beyond.” Key Recent Highlights EB613: First Oral PTH(1-34) Anabolic Treatment for Osteoporosis FDA Agreement that BMD Primary Endpoint Would Support NDA: In a July Type A meeting, FDA provided written concurrence on our Phase 3 study design - a single multinational, randomized, double-blind, placebo-controlled, 24-month study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpo...

Conference call begins at 4:30 p.m. Eastern time today MIAMI, July 31, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three and six months ended June 30, 2025. Highlights from the second quarter of 2025 and recent weeks include the following: Merck advanced Phase 1 Epstein-Barr virus vaccine trial (NCT06655324). This investigational vaccine candidate is being developed in collaboration with Merck and evaluates safety and tolerability in up to 200 healthy adults. Based on analysis of these results, Merck will determine whether and how to proceed with Phase 2 studies. ModeX continued to advance its immuno-oncology and immunology portfolio with four potential clinical candidates progressing. The MDX2001 CMet-Trop2/CD3-CD28 tetraspecific antibody has advanced to the fifth dose level in its Phase 1 clinical trial, with Phase 1b studies in selected solid tumors expected in 2026. MDX2004, a multispecific immune rejuvenator, is expected to enter the clinic later this year. Human clinical trials with the MDX2003 tetraspecific antibody for lymphoma/leukemia are expected to begin in early 2026. Development of multispecific antibodies for immune impaired patients at risk for COVID and influenza continued to progress with support from the Biomedical Advanced Research and Development Authority (BARDA). Presented preclinical data on OPK-88006, OPKO’s novel long-acting glucagon-like peptide-1 receptor/glucagon receptor dual agonist in a poster presentation at the American Diabetes Association 85th Scientific Sessions in June. Clinical pharmacology assessments of OPK-88006 in disease models of obesity and energy expenditure activities were encouraging. The presented data compared the 12-week daily treatment outcomes of OPK-88006, semaglutide and survodutide in a GAN diet induced obese and biopsy confirmed mouse model of metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis. In this study, the therapeutic benefits of OPK-88006 on quantitative biological hallmarks of MASH were superior to semaglutide and survodutide, suggesting that OPK-88006 is a promising GLP-1/glucagon receptor dual agonist for the treatment of MASH. Abstract for first-in-class dual GLP-1/glucagon tablet candidate for patients with obesity and metabolic disorders selected for presentation at the ENDO 2025 annual meetin...

JERUSALEM, May 09, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptide and protein replacement therapies, today reported financial results and key business updates for the quarter ended March 31, 2025. “During Q1 2025, Entera continued to generate intrinsic value with progress across our programs while significantly extending our cash runway into late 2026 via direct investment from marquis investors and our strategic partner, OPKO Health Inc. (“OPKO”). EB613 early mechanistic effects on both trabecular and cortical bone compartments data using 3D-Shaper software analysis was selected for oral presentation out of 1,680 abstracts submitted to the 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases Congress. Subsequent EB613 abstracts have been submitted to both the 2025 American Society for Bone Mineral Research (ASBMR) and the North American Menopause Society (NAMS) conferences. Pre-IND activities for our Next Gen EB613 tablet candidate are in final stages, with plans to initiate a Phase 1 study in H2 2025. Via the execution of our recent license agreement with OPKO, we are fully funded to co-develop Oral OPK-88006 (the first dual acting GLP1/Glucagon single tablet for metabolic diseases) through SAD/MAD Phase 1 studies while retaining a 40% stake in the economics of this important asset. An abstract for Oral OPK-88006 has been submitted to ENDO2025. Finally, we are judiciously strengthening our core team with important appointments including Ms. Leslie Gautam, as Chief Business Officer and Ms. Cherin Smith as Head of Clinical Operations, both of whom have extensive experience in strategic and operational execution in women-centric conditions,” said Miranda Toledano, Chief Executive Officer of Entera. “We continue to optimize and prepare to initiate our proposed pivotal program for EB613, the first and only oral anabolic “bone building” tablet treatment under clinical investigation in postmenopausal women with osteoporosis. The earlier the age at which menopause occurs the greater the risk of long-term impact on bone and heart health. EB613 is specifically intended to provide an oral anabolic treatment in tablet format earlier in an osteoporosis patient’s journey to increase skeletal mass and reduce the risk of fracture. EB613 comprises the first 34 N-terminal amino acid sequence o...

JERUSALEM, March 28, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, today reported financial results and key business achievements for the year ended December 31, 2024. “2024 was a truly transformational year for Entera. We delivered key data read-outs and advanced each of our oral peptide PTH(1-34), GLP1/Glucagon and GLP2 tablet programs, significantly increased our stockholder value, and efficiently strengthened our balance sheet. To our core team with whom I started this journey in late 2022 as a board member, and to our rapidly expanding ecosystem of premier global advisors, I thank you for your commitment and dedication. To our existing and new shareholders, we are grateful for your belief and support of our thesis. To our collaborators, especially, the formidable team at OPKO Health, Inc., we are grateful for your partnership and the opportunity to expand our N-Tab™ platform to additional high value peptides,” said Miranda Toledano, Chief Executive Officer of Entera. “To our potential patient base for whom we are developing EB613: the majority of the estimated 200 million women with osteoporosis who wish to preserve their bone health, who remain underserved with current treatments and who have not been able to access a new therapy since 2019, our dedication to you is firm and unwavering. Osteoporosis is one of the foremost underserved health issues globally which disproportionally afflicts women. Most women experience menopause between the ages of 45 and 55 years. One in three women over age 50 will develop osteoporosis, and one in two of those women will develop an osteoporosis-related fracture. The morbidity and mortality risk of osteoporosis fractures to women outpaces that of breast cancer, stroke and heart attack combined. Nevertheless, most patients remain untreated. Furthermore, existing regulatory guidelines requiring fracture outcomes have curtailed innovation in this significant disease due to ethical, time and sizing of studies required to evaluate new treatments. The SABRE (Study to Advance Bone Mineral Density as a Regulatory Endpoint), based on a statistical meta-analysis of over 170,000 patients across 53 randomized clinical studies and 7 osteoporosis drug classes correlating total hip BMD to fracture outcomes, is undergoing review at FDA. This is...