| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | June 6, 2025 4:00 P.M. |
| Form: | S-3 | ||||||
| |||||||
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8-K - Entera Bio Ltd. (0001638097) (Filer)
8-K - Entera Bio Ltd. (0001638097) (Filer)
10-Q - Entera Bio Ltd. (0001638097) (Filer)
3 - Entera Bio Ltd. (0001638097) (Issuer)
3 - Entera Bio Ltd. (0001638097) (Issuer)
4 - Entera Bio Ltd. (0001638097) (Issuer)
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. "
This is the third program that successfully combines Entera's oral peptide N-Tab® platform with OPKO's advanced protein chemistry capabilities The companies have accelerated this program and aim to file an investigational new drug (IND) application in late 2026 Injectable and oral oxyntomodulin (dual GLP-1/glucagon analog) for metabolic and fibrotic disorders advancing with initial Phase 1 data from injectable oxyntomodulin (OXM) expected in late 2026; oral OXM to enter clinic thereafter Industry veteran Steve Rubin joins Entera's board MIAMI and TEL AVIV, Israel, Feb. 04, 2026 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK), through its wholly owned subsidiary, OPKO Biologics (OPKO
Final EB613 Phase 3 Protocol Submission to FDA Planned for Q1 2026, Following December 19th 2025 FDA Ruling Next-Generation EB613 Phase 1 Bridging Study Progressing with Results Expected During Q1 2026 Oral Hypoparathyroidism Tablet Program to Accelerate with Lead Long-Acting PTH Variants Strategic Partnership Discussions Advancing Across Pipeline JERUSALEM, Jan. 21, 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 its expected corporate milestones for the first quarter of 2026. "We expect to achieve three important goals during Q1 2026
4 - Entera Bio Ltd. (0001638097) (Issuer)
4 - Entera Bio Ltd. (0001638097) (Issuer)
4 - Entera Bio Ltd. (0001638097) (Issuer)
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
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
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
SC 13G/A - Entera Bio Ltd. (0001638097) (Subject)
SC 13G/A - Entera Bio Ltd. (0001638097) (Subject)
SC 13G/A - Entera Bio Ltd. (0001638097) (Subject)