ENTX
NASDAQEntera Bio Ltd.
Price$1.54+0.20 (+15.30%)
01:30 PM07:45 PM
News · 26 weeks49-45%
2025-12-282026-06-21
Mix2590d
- Other11(44%)
- SEC Filings11(44%)
- Insider3(12%)
Latest news
25 items- PRPositive FDA Feedback on Phase 3 Brings Entera Bio's Oral Osteoporosis Pill One Step Closer to MarketEntera 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
- PREntera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with OsteoporosisThe 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
- PREntera Reports Robust Preclinical Data for EB612 (Oral LA-PTH(1-34)) for Hypoparathyroidism and EB618 (Oral GLP-1/Glucagon) for Obesity at ENDO 2026EB612, 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
- PRENDO 2026 Oral Presentation Highlights Comparative Clinical Data for Entera's Breakthrough Single Tablet EB613 (First-in-Class Oral PTH(1-34) Anabolic for Osteoporosis)The pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single tablet EB613, multi-tablet EB613 and Forteo® reported for the first time as an oral presentation at ENDO 2026 Single tablet EB613 achieved a comparable PK/PD profile to Forteo® and multi-tablet EB613, which was evaluated in Entera's Phase 2 study in postmenopausal women with osteoporosis and low bone mass This major scientific achievement supports advancing single tablet EB613 into Entera's planned Phase 3 study of EB613 in postmenopausal women with osteoporosis TEL AVIV, June 15, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today r
- SECSEC Form DEFA14A filed by Entera Bio Ltd.DEFA14A - Entera Bio Ltd. (0001638097) (Filer)
- SECSEC Form DEF 14A filed by Entera Bio Ltd.DEF 14A - Entera Bio Ltd. (0001638097) (Filer)
- PREntera'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 PresentationTEL AVIV, May 28, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today announced that multiple abstracts across its oral peptide pipeline have been accepted for presentation at ENDO 2026, the annual meeting of the Endocrine Society, taking place June 13-16, 2026 in Chicago, Illinois, USA. Notably, new clinical data supporting Entera's single EB613 tablet as the final candidate for its planned Phase 3 study in postmenopausal women with osteoporosis was selected for a Late Breaking Oral Presentation. Abstract Title: Transforming Anabolic Treatments for Osteoporosis: New Clinical Data Supports a Single EB613 T
- SECSEC Form EFFECT filed by Entera Bio Ltd.EFFECT - Entera Bio Ltd. (0001638097) (Filer)
- SECSEC Form 424B3 filed by Entera Bio Ltd.424B3 - Entera Bio Ltd. (0001638097) (Filer)
- SECSEC Form PRE 14A filed by Entera Bio Ltd.PRE 14A - Entera Bio Ltd. (0001638097) (Filer)
- INSIDERChief Operating Officer Galitzer Hillel was granted 72,993 units of Ordinary Shares, increasing direct ownership by 81% to 163,566 units (SEC Form 4)4 - Entera Bio Ltd. (0001638097) (Issuer)
- INSIDERChief Financial Officer Yaacov-Garbeli Dana was granted 58,394 units of Ordinary Shares (SEC Form 4)4 - Entera Bio Ltd. (0001638097) (Issuer)
- INSIDERChief of R&D Burshtein Gregory was granted 87,591 units of Ordinary Shares, increasing direct ownership by 86% to 189,033 units (SEC Form 4)4 - Entera Bio Ltd. (0001638097) (Issuer)
- SECSEC Form S-3 filed by Entera Bio Ltd.S-3 - Entera Bio Ltd. (0001638097) (Filer)
- SECSEC Form 10-Q filed by Entera Bio Ltd.10-Q - Entera Bio Ltd. (0001638097) (Filer)
- SECEntera Bio Ltd. filed SEC Form 8-K: Results of Operations and Financial Condition, Regulation FD Disclosure, Financial Statements and Exhibits8-K - Entera Bio Ltd. (0001638097) (Filer)
- PREntera Announces First Quarter 2026 Financial Results and Updates Across its Oral Peptide ProgramsEB613, 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
- PRBriefCast Publishes Transcript: Entera Bio's Osteoporosis KOL Roundtable on EB613 - Oral Anabolic Tablet OpportunityIn a virtual Key Opinion Leader (KOL) roundtable hosted today, Entera Bio (NASDAQ:ENTX) convened globally recognized authorities in osteoporosis and women's health to discuss the current osteoporosis treatment landscape and the opportunity for its lead clinical candidate, EB613 - being developed as the first and only oral anabolic (bone-forming) tablet for osteoporosis. The discussion featured Dr. Felicia Cosman, Professor of Medicine at Columbia University and a globally recognized authority in osteoporosis and anabolic therapies, and Dr. Steven Goldstein, Professor of Obstetrics and Gynecology at NYU Grossman School of Medicine and former President of both the International Menopause Soci
- PREntera Bio to Host Key Opinion Leader Webinar Highlighting the Osteoporosis Treatment Landscape and the Opportunity for EB613TEL AVIV, Israel, April 14, 2026 (GLOBE NEWSWIRE) -- TEL AVIV, Israel, April 14, 2026 -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today announced it will host a virtual Key Opinion Leader (KOL) webinar focused on the osteoporosis treatment landscape and the opportunity for its lead clinical candidate, EB613 (oral PTH (1-34) tablet), on Monday, April 20, 2026 at 11:00 AM Eastern Time. Attendance for the event requires registration. Participants may register at the following link: https://events.zoom.us/ev/AjJwNRe2lJ20ip76GJ4k0Ee_SLHBTKEcb9Iabu7PDwVyGRBCzqr_~AqIJON0d6_lhurfYvEmThe3o4X3G0iFAy9zFmuBnQMCqifflBtC23k66Fg The roundt
- PRGreenberg Traurig Represents Israel-based Entera Bio in $10M Private Placement Led by BVF PartnersMIAMI, April 6, 2026 /PRNewswire/ -- Global law firm Greenberg Traurig, P.A. advised Israel-based Entera Bio Ltd. (NASDAQ:ENTX), a clinical-stage biotechnology company focused on the development of oral peptide and protein replacement therapies, in a $10 million private placement led by funds affiliated with private investment firm BVF Partners L.P. Under the terms of the transaction, which closed April 2, Entera issued and sold an aggregate of 7,827,789 units at a purchase price of $1.2775 per unit, according to the company's press release. Each unit consists of one ordinary sh
- SECEntera Bio Ltd. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits8-K - Entera Bio Ltd. (0001638097) (Filer)
- PREntera Bio Announces Pricing of $10.0 Million Direct Investment by BVF Partners with Potential for up to $24.5 Million in Total ProceedsTEL AVIV, Israel, April 02, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today announced that it has entered into a securities purchase agreement for a private placement (the "Private Placement") led by funds affiliated with BVF Partners L.P. ("BVF"). The Private Placement is expected to close on or about April 2, 2026, subject to customary closing conditions. Pursuant to the Private Placement, the Company agreed to issue and sell an aggregate of 7,827,789 units (the "Units") at a purchase price of $1.2775 per Unit. Each Unit consists of (i) one ordinary share of Entera (or, in lieu thereof, one pre-funde
- SECSEC Form 10-K filed by Entera Bio Ltd.10-K - Entera Bio Ltd. (0001638097) (Filer)
- SECEntera Bio Ltd. filed SEC Form 8-K: Results of Operations and Financial Condition, Regulation FD Disclosure, Financial Statements and Exhibits8-K - Entera Bio Ltd. (0001638097) (Filer)
- PREntera Bio Announces Full Year 2025 Financial Results and Provides Business UpdatesEB613, 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) -
ENTX FAQ
6 questionsWhat does Entera Bio Ltd. do?
Entera Bio Ltd., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of orally delivered large molecule therapeutics for unmet medical needs. The company's lead product candidates include the EB612, an oral parathyroid hormone product candidate, which is in Phase 2 clinical trials for the treatment of hypoparathyroidism; and EB613 that is in Phase 2 clinical trials for the treatment of osteoporosis. It is also developing EB613 for the treatment of non-union fractures. The company has a research collaboration and license agreement with the Amgen Inc...Where does ENTX stock trade?
Entera Bio Ltd. (ENTX) is listed on NASDAQ.What sector and industry is ENTX in?
Entera Bio Ltd. operates in the Health Care sector, Biotechnology: Biological Products (No Diagnostic Substances) industry.When did Entera Bio Ltd. go public?
Entera Bio Ltd. (ENTX) completed its IPO in 2018.What companies are similar to ENTX?
Notable peers in the same industry include AMGN (Amgen Inc.), GILD (Gilead Sciences Inc.), ARGX (argenx SE), RVMD (Revolution Medicines Inc.), BIIB (Biogen Inc.). Compare ENTX side-by-side with any of them on Quantisnow.How can I track ENTX on Quantisnow?
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