Welcome to our dedicated page for Entera Bio news (Ticker: ENTX), a resource for investors and traders seeking the latest updates and insights on Entera Bio stock.
Entera Bio Ltd. (NASDAQ: ENTX) generates a steady flow of news as a clinical-stage biopharmaceutical company developing oral peptide and protein replacement therapies. News coverage on this page focuses on the company’s progress with its proprietary N-Tab™ oral peptide platform and its pipeline of tablet-based biologic candidates.
Investors and followers of ENTX can use this news feed to track key developments around EB613, Entera Bio’s lead oral PTH(1-34) (teriparatide) osteoanabolic tablet for postmenopausal women with osteoporosis or low bone mineral density. Updates often include Phase 2 clinical data, post-hoc analyses of bone mineral density outcomes, presentations at bone and endocrine conferences, and regulatory milestones such as FDA alignment on Phase 3 trial design and acceptance of total hip BMD as a primary endpoint.
The news stream also highlights progress in the EB612 program for hypoparathyroidism, including preclinical pharmacokinetic and pharmacodynamic data for a proprietary long-acting PTH analog formulated as a once-daily oral tablet. Coverage extends to Entera Bio’s collaboration with OPKO Health on oral GLP-2 and oxyntomodulin tablet candidates, with reports on preclinical data for short bowel syndrome and obesity programs presented at international nutrition and endocrine meetings.
In addition, readers will find quarterly financial results, business updates, participation in healthcare and investor conferences, and commentary from company leadership on strategy and clinical priorities. This page brings together ENTX press releases and related announcements so that investors, clinicians and other stakeholders can follow the company’s clinical, regulatory and collaboration milestones in one place.
Entera Bio (Nasdaq: ENTX) agreed to a private placement led by BVF Partners to sell 7,827,789 units at $1.2775 per unit for gross proceeds of approximately $10.0 million, with potential additional proceeds of ~$14.5 million if warrants are exercised, for total possible proceeds of ~$24.5 million.
Each unit includes one ordinary share (or a pre-funded warrant) and a five-year warrant to buy 1.5 shares at $1.24 (an 11.7% premium to the March 31 close). Proceeds are intended to support initiation of the phase 3 EB613 registrational study and general corporate purposes.
Entera Bio (NASDAQ: ENTX) reported 2025 results and pipeline progress. Cash and equivalents were $14.9M (includes $7.8M restricted); cash runway is expected through mid‑Q3 2026. The company advanced EB613 to a streamlined Phase 3 plan, secured FDA Type A alignment on BMD as a primary endpoint, and expanded an OPKO collaboration to accelerate EB612.
Entera submitted a Phase 3 protocol amendment for EB613, expects FDA feedback in late April 2026, plans study start in late 2026 and potential topline in H2 2028.
Entera Bio (NASDAQ: ENTX) submitted a streamlined Phase 3 protocol, statistical analysis plan and 12-month open-label extension synopsis to the FDA to support an NDA for EB613 (oral teriparatide).
The multinational randomized trial targets 750 postmenopausal women with total hip BMD as the primary endpoint at month 12. Entera plans to use a single-tablet Next-Gen EB613 formulation, expects FDA feedback within 60 days, to start dosing in late 2026 and aims for topline data in H2 2028.
Entera Bio (NASDAQ: ENTX) announced that CEO Miranda Toledano will take part in a fireside chat at the Leerink Partners Global Healthcare Conference 2026.
The session is scheduled for March 11, 2026 at 10:40 a.m. ET in Miami; a live webcast and slides will be available, with a replay accessible for 365 days.
Entera Bio (NASDAQ: ENTX) announced that several board members, including Chairman Geno J. Germano, made open market purchases of the company’s ordinary shares on Feb 11, 2026.
The news notes prior insider buying by CEO Miranda Toledano in December 2025 and says transaction details and prices are reported in SEC filings.
Entera Bio (NASDAQ: ENTX) appointed Geno J. Germano as Chairman of the Board, effective February 4, 2026, succeeding Gerald Lieberman. Entera plans to advance two oral PTH peptide programs into clinical testing in 2026, including a Phase 3 registrational study for EB613 in osteoporosis and a first-in-human study for Long-Acting Oral PTH in hypoparathyroidism. Mr. Germano brings over three decades of biopharma leadership, including leading an approximately $14 billion innovative medicines portfolio at Pfizer, and board experience across multiple biotech companies.
Entera Bio (NASDAQ:ENTX) and OPKO Health expanded their 2025 collaboration to advance a first-in-class oral long-acting PTH (LA-PTH) tablet for hypoparathyroidism, combining OPKO's long-acting PTH variants with Entera's N-Tab® oral peptide platform.
The companies will each hold a 50% pro-rata ownership of the LA-PTH program and share development costs 50/50, and expect to file an IND in late 2026. The firms maintain a 60%/40% (OPKO/Entera) split for the oral oxyntomodulin (OXM) program; Phase 1 injectable OXM data is expected by end of 2026. Steve Rubin joined Entera's board as Gerry Ostrov steps down.
Entera Bio (NASDAQ: ENTX) outlined Q1 2026 corporate priorities focused on its oral PTH programs. Key near-term milestones: final EB613 Phase 3 protocol submission to FDA planned for Q1 2026 following FDA alignment and a December 19, 2025 qualification of BMD as a regulatory endpoint. A Next‑Gen EB613 Phase 1 bridging study that began in Nov 2025 is progressing with results expected by end of Q1 2026. The company also plans to accelerate EB612, its long‑acting oral PTH candidate for hypoparathyroidism, into clinic in 2026 based on preclinical PK/PD data announced in Dec 2025.
Entera noted prior Phase 2 EB613 results (n=161) met primary PD and secondary BMD endpoints and said it is pursuing strategic partnerships across the pipeline.
Entera Bio (NASDAQ: ENTX) congratulated the FNIH‑ASBMR‑SABRE team after the FDA on Dec 23, 2025 broadly qualified total hip BMD as a validated surrogate regulatory endpoint for novel osteoporosis drugs in post‑menopausal women at risk of fracture.
Entera highlighted that this qualification reinforces its July 2025 FDA alignment that a single Phase 3 using total hip BMD as the primary endpoint could support an NDA for EB613, and said the move may simplify and accelerate osteoporosis drug development while acknowledging remaining ethical and trial recruitment challenges.
Entera Bio (NASDAQ: ENTX) reported preclinical PK–PD data for its EB612 program showing a proprietary long-acting PTH analog administered as a single oral tablet produced a markedly longer plasma half-life and sustained serum calcium elevation for >3 days in a five‑animal minipig study versus unmodified PTH(1‑34) controls, which showed no calcium response. The company said no adverse events were observed and positions the data as support for development of a once-daily oral PTH tablet for hypoparathyroidism. Entera plans to present the data at an upcoming medical conference.