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B. Riley Securities initiated coverage of Entera Bio with a rating of Buy and set a new price target of $9.00
Aegis Capital initiated coverage of Entera Bio with a rating of Buy and set a new price target of $12.00
Maxim Group reiterated coverage of Entera Bio with a rating of Buy and set a new price target of $10.00 from $5.00 previously
Entera Bio (NASDAQ:ENTX) may have just cleared its biggest regulatory hurdle yet. The FDA has provided positive feedback on the Phase 3 protocol for EB613, the company's oral osteoporosis tablet, creating a clear path toward potential approval and bringing what could become the first oral anabolic osteoporosis treatment one step closer to market. To view the original report published on June 22, 2026, click here or follow the link:https://www.benzinga.com/content/60014792/positive-fda-feedback-phase-3-entera-bio-just-got-answer-market-was-waiting NY, June 23, 2026 (GLOBE NEWSWIRE) -- CATALYST REPORT // Yesterday brought what may turn out to be the most consequential regulatory update
The planned Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of total hip bone mineral density (BMD) at Month 12, would support Entera’s plan to submit a New Drug Application (NDA) for EB613 Entera expects to submit its NDA for EB613 based on 12-month data, with an open-label extension study to follow patients through 24 months to supplement EB613’s safety, durability of effect and sequence data Phase 3 initiation is planned for late 2026 with topline data anticipated in the second half of 2028 TEL AVIV, June 22, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera" or the "Company"), a leader in the development of oral pepti
EB612, a first-in-class long-acting PTH(1-34) oral peptide for hypoparathyroidism, produced robust bioavailability and sustained increases in calcium across three preclinical models; IND is expected in late 2026 EB618, a first-in-class dual GLP-1/glucagon oral receptor agonist (oxyntomodulin) for obesity and metabolic disorders, showed dose-proportional pharmacokinetics and a robust effect on blood glucose in non-human primates TEL AVIV, June 16, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera"), a leader in the development of oral peptides, reported preclinical data at ENDO 2026, the annual meeting of the Endocrine Society, for its EB612 and EB618 pipeline programs. Bo
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4 - Entera Bio Ltd. (0001638097) (Issuer)
4 - Entera Bio Ltd. (0001638097) (Issuer)
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JERUSALEM, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today announced its financial results for the third quarter of 2022 and provided the following corporate updates. Corporate Updates: Achieved FDA Agreement for Pivotal Study of EB613, the World's First Daily Bone Forming Oral PTH Tablet On October 6th, 2022, Entera announced that it had successfully completed its Type C meeting and reached a record agreement with the U.S. Food and Drug Administration (FDA) that a single pivotal Phase 3 placebo-controlled study could support a New Drug Application (NDA)
Registrational study design for lead clinical asset, EB613, as the first oral PTH anabolic to treat post-menopausal women at high risk of osteoporosis, is underwayCompany reschedules conference call and webcast to Wednesday, May 18 at 8:00 AM EDT BOSTON and JERUSALEM, May 12, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, today announced its financial and operating results for the quarter ended March 31, 2022. First Quarter 2022 and Recent Highlights EB613 Clinical Update: Entera's lead clinical candidate, EB613, an oral formulation of human parathyroid hormone (1-34), o
BOSTON and JERUSALEM, April 28, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, announced today it will report business and financial results for the three months ended March 31, 2022 on Thursday, May 12, 2022 at 8:30 AM EDT. Thursday, May 12, 2022, 8:30 AM EDTDomestic: 877-269-7756International: 201-689-7817Israel: 1809406247Conference ID: 13728252 Webcast: Entera Bio Earnings Webcast A replay of the webcast will be archived on Entera's website for approximately 45 days following the call. About Entera BioEntera is a leader in the development of orally delivered large molecule therapeutics for use in a
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TEL AVIV, Feb. 09, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide and protein replacement therapies, today announced that its Board of Directors has appointed Geno J. Germano as Chairman of the Board, effective February 4, 2026. Mr. Germano succeeds Gerald Lieberman, who is stepping down as Chairman. The appointment follows a period of accelerating progress across Entera's pipeline as the Company plans to advance two oral PTH peptide programs into clinical testing within 2026, a Phase 3 registrational study for EB613 in osteoporosis and a first-in-human study for Long-Acting Oral PTH in hypoparathyroidism. "
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 submit
JERUSALEM, May 15, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), ("Entera" or the "Company"), a leader in the development of orally delivered peptides and small therapeutic proteins, today announced the appointment of Rachel B Wagman, MD, FACE, FACP, as Key Clinical Advisor and Member of its Scientific Advisory Board. Dr. Wagman brings more than 20 years of metabolic bone disease and women's health research and drug development experience to Entera. She has successfully advanced the development of five molecules, including the osteoporosis products teriparatide (Forteo®), denosumab (Prolia®) and romosozumab (Evenity®) through clinical development, registration, and lifecycle mana