ENTX May 28, 2026ENTXConferences/Events
Entera’s EB613, First-in-Class Oral PTH(1-34) Anabolic for Osteoporosis - Single Tablet Data Selected for Late Breaking Oral Presentation at ENDO 2026 Annual Meeting; Additional Oral Peptide Pipeline Data Accepted for Presentation
Entera Bio Ltd. announced that its EB613 tablet, an oral PTH(1-34) anabolic treatment for osteoporosis, has been selected for a Late Breaking Oral Presentation at the ENDO 2026 Annual Meeting. The presentation will showcase new clinical data supporting EB613 as the final candidate for a planned Phase 3 study in postmenopausal women. Additionally, other abstracts from Entera's oral peptide pipeline have been accepted for presentation.
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ENTX Apr 14, 2026ENTXConferences/Events
Entera Bio to Host Key Opinion Leader Webinar Highlighting the Osteoporosis Treatment Landscape and the Opportunity for EB613
Entera Bio Ltd. is set to host a Key Opinion Leader webinar on April 20, 2026, focusing on osteoporosis treatment and its candidate EB613. The event will feature discussions with leading experts on women's bone health and the current treatment landscape. EB613 has shown positive results in clinical trials, positioning it as a potential first oral anabolic therapy for osteoporosis.
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ENTX Apr 2, 2026ENTXGeneral
Entera Bio Announces Pricing of $10.0 Million Direct Investment by BVF Partners with Potential for up to $24.5 Million in Total Proceeds
Entera Bio Ltd. has announced a private placement led by BVF Partners, raising approximately $10 million, with the potential for total proceeds of $24.5 million. The funds will be used to initiate a Phase 3 study of EB613, an oral treatment for postmenopausal women with osteoporosis. The placement is set to close around April 2, 2026.
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ENTX Mar 30, 2026ENTXPhases
Entera Bio Announces Full Year 2025 Financial Results and Provides Business Updates
Entera Bio announced its financial results for 2025, highlighting significant progress in its pipeline, including the submission of a Phase 3 protocol for EB613, an oral anabolic peptide for osteoporosis. The company aims to make anabolic treatment more accessible. Despite a net loss of $11.4 million, Entera is optimistic about its innovative oral peptide therapies.
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ENTX Mar 4, 2026ENTXPhases
Entera Bio Submits Streamlined Phase 3 Protocol to Initiate Registrational Program for EB613 in Postmenopausal Women with Osteoporosis
Entera Bio has submitted a streamlined Phase 3 protocol to the FDA for EB613, an oral treatment for postmenopausal osteoporosis. The study aims to evaluate the drug's efficacy in increasing total hip bone mineral density (BMD) over 12 months. The new single tablet formulation is expected to enhance patient compliance and accelerate the path to approval, with topline results anticipated in late 2028.
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ENTX Feb 26, 2026ENTXConferences/Events
Entera Bio to Participate in the Leerink Partners 2026 Global Healthcare Conference
Entera Bio Ltd. announced that CEO Miranda Toledano will participate in the Leerink Partners Global Healthcare Conference 2026. The event will take place on March 11, 2026, in Miami, Florida. A live webcast will be available for those unable to attend in person, with a replay accessible for 365 days. Entera is known for its innovative oral peptide therapies.
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ENTX Feb 11, 2026ENTXGeneral
Entera Bio Announces Open Market Purchases of Company Stock by Board Members
Entera Bio Ltd. announced that several board members, including the Chairman, purchased shares in the company, reflecting their confidence in its future. This follows a previous purchase by the CEO. Entera is focused on developing oral peptide therapies, with promising clinical trial results for its lead candidate, EB613, aimed at treating osteoporosis.
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ENTX Feb 9, 2026ENTXGeneral
Entera Bio Appoints Former Pfizer Executive Geno J. Germano as Chairman of the Board Ahead of Key Milestones
Entera Bio Ltd. has appointed Geno J. Germano as Chairman of the Board, effective February 4, 2026. This leadership change comes as the company prepares to advance two oral peptide programs into clinical trials, including a Phase 3 study for EB613 in osteoporosis. Germano's extensive experience in the biopharmaceutical industry is expected to benefit Entera as it moves forward with its innovative therapies.
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ENTX Feb 4, 2026ENTXGeneral
OPKO Health and Entera Bio Expand Partnership to Advance First-in-Class Oral Long Acting PTH Tablet for Patients with Hypoparathyroidism
OPKO Health and Entera Bio have expanded their partnership to develop a first-in-class oral long-acting PTH tablet for hypoparathyroidism. The companies aim to file an IND application with the FDA by late 2026, leveraging Entera's N-Tab technology and OPKO's protein chemistry expertise. This collaboration seeks to provide a more convenient treatment option for patients currently reliant on daily injections.
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ENTX Jan 22, 2026ENTXPhases
Entera Bio Announces Upcoming Q1 2026 Corporate Priorities and Pipeline Outlook
Entera Bio has outlined its corporate priorities for Q1 2026, including the submission of its EB613 Phase 3 protocol to the FDA. The company is also progressing with its Next-Gen EB613 Phase 1 bridging study, with results expected soon. Additionally, Entera plans to accelerate its hypoparathyroidism program and is engaging in strategic partnership discussions.
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ENTX Dec 24, 2025ENTXFDA Updates
Entera Bio Congratulates the FNIH-ASBMR-SABRE Team on FDA’s Qualification of Total Hip BMD as Regulatory Endpoint: Huge Win for Osteoporosis Innovation
Entera Bio has expressed its congratulations to the FNIH-ASBMR-SABRE team following the FDA's qualification of total hip bone mineral density (BMD) as a regulatory endpoint for osteoporosis drug development. This qualification supports Entera's strategy for its oral treatment, EB613, which aims to provide a new anabolic option for patients. The FDA's decision is expected to simplify the path for Entera's future regulatory submissions.
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ENTX Dec 22, 2025ENTXPhases
Entera Bio Announces New Data Supporting Further Development of a Proprietary First-in-Class Oral, Long-Acting PTH Tablet for Patients with Hypoparathyroidism (EB612 Program)
Entera Bio has announced promising new data for its EB612 program, which focuses on a long-acting oral parathyroid hormone (PTH) tablet for hypoparathyroidism. The preclinical results indicate a significantly longer plasma half-life and sustained calcium levels compared to existing treatments. This advancement aims to simplify treatment for patients, moving from multiple daily doses to a single daily tablet.
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ENTX Oct 23, 2025ENTXPhases
Entera Bio Presents Positive New Clinical Data from EB613 Phase 2 Trial Demonstrating Significant Bone Density Improvements in Early Postmenopausal Women
Entera Bio has presented positive clinical data from its Phase 2 trial of EB613 at the NAMS 2025 meeting. The oral PTH(1-34) treatment demonstrated significant increases in bone mineral density among early postmenopausal women. Entera plans to initiate a global Phase 3 study following FDA concurrence in July 2025.
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ENTX Oct 16, 2025ENTXPhases
Entera Bio to Present New Clinical Data from Phase 2 Trial of EB613 at the 2025 North American Menopause Society (NAMS) Annual Meeting
Entera Bio Ltd. will present new clinical data from its Phase 2 trial of EB613 at the NAMS 2025 Annual Meeting. The data focuses on early postmenopausal women with low bone mass or osteoporosis, highlighting the potential of EB613 as an oral anabolic therapy. This marks Entera's first presentation at NAMS, emphasizing the need for accessible treatment options in this demographic.
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ENTX Sep 15, 2025ENTXFDA Updates
Entera Bio Reports Positive PK Data for First-in-Class Oral GLP-2 Tablet Treatment for Patients with Short Bowel Syndrome at the 2025 ESPEN Congress
Entera Bio has reported positive pharmacokinetic data for its first-in-class oral GLP-2 tablet aimed at treating Short Bowel Syndrome (SBS) during the 2025 ESPEN Congress. This oral therapy could significantly improve the treatment landscape for approximately 30,000 SBS patients who currently depend on daily injections. The collaboration with OPKO Health is expected to bolster the development of this innovative therapy.
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ENTX Sep 8, 2025ENTXPhases
Entera Bio Presents Positive Effects of EB613 on Both Trabecular and Cortical Bone in Postmenopausal Women with Osteoporosis at ASBMR 2025
Entera Bio presented positive data on EB613 at the ASBMR 2025 Annual Meeting, highlighting significant improvements in both trabecular and cortical bone after six months of treatment in postmenopausal women with osteoporosis. The company plans to initiate a global Phase 3 study following FDA concurrence in July 2025. Additionally, promising pharmacokinetic data for a next-generation EB613 tablet candidate was shared.
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ENTX Aug 28, 2025ENTXPhases
Entera Bio to Unveil Clinical and Non-Clinical Data Across 3 Oral Peptide Programs at Upcoming September Conferences
Entera Bio Ltd. announced it will present data on three oral peptide programs at upcoming September conferences. The highlights include EB613, an oral anabolic treatment for postmenopausal osteoporosis, which has shown positive Phase 2 results. The company is preparing for a Phase 3 registration study with FDA alignment, indicating a significant step forward in their clinical development.
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ENTX Aug 8, 2025ENTXFDA Updates
Entera Bio Announces Second Quarter 2025 Financial Results and Business Updates
Entera Bio Ltd. reported its Q2 2025 financial results, highlighting a pivotal FDA agreement for EB613's Phase 3 program. The company has a strong cash position of $18.9 million, enabling continued development of its pipeline, including oral therapies for osteoporosis and obesity. However, it also reported a net loss of $2.7 million, reflecting increased R&D expenses.
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ENTX Jul 28, 2025ENTXFDA Updates
Entera Bio Receives FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study in Post-Menopausal Women with Osteoporosis
Entera Bio has received FDA agreement to use bone mineral density (BMD) as the primary endpoint in its Phase 3 study for EB613, aimed at treating postmenopausal osteoporosis. This decision allows Entera to proceed without waiting for the qualification of BMD as a regulatory endpoint. The study will evaluate changes in total hip BMD over 24 months, with the incidence of vertebral fractures as a secondary endpoint. EB613 is positioned as the first oral anabolic treatment for osteoporosis.
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ENTX Jul 8, 2025ENTXConferences/Events
OPKO Health and Entera Bio Announce Abstract on PK/PD of Oral GLP-2 Tablet for the Treatment of Short Bowel Syndrome Selected for 2025 ESPEN Congress
OPKO Health and Entera Bio announced their abstract on a first-in-class oral GLP-2 analog for treating short bowel syndrome has been selected for presentation at the 2025 ESPEN Congress. This oral tablet aims to improve patient compliance compared to existing injectable therapies. The companies believe this innovation could enhance personalized care for patients suffering from this condition.
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ENTX Jun 25, 2025ENTXConferences/Events
OPKO Health and Entera Bio 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 Meeting
OPKO Health and Entera Bio announced that their investigational oral tablet OPK-88006 will be presented at the ENDO 2025 annual meeting. This dual GLP-1/glucagon agonist aims to provide treatment for obesity and metabolic disorders. The companies plan to file an Investigational New Drug application with the FDA later this year, with Phase 1 clinical studies in the pipeline.
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