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. develops orally delivered peptide and protein replacement therapies as a clinical-stage biopharmaceutical company. News about ENTX centers on its N-Tab® oral peptide platform and pipeline candidates, including EB613, an oral PTH(1-34) tablet for osteoporosis, and EB612, a long-acting oral PTH peptide replacement tablet for hypoparathyroidism.
Recurring updates also cover FDA communications and clinical-development plans, OPKO collaboration activity, financial results, private placements and warrant-linked capital actions, board and governance changes, and medical-community discussions around osteoporosis and oral anabolic therapy.
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.
Entera Bio (Nasdaq: ENTX) announced that CEO Miranda Toledano will participate in a fireside chat at the 8th Annual Evercore ISI Healthcare Conference on Dec 3, 2025 at 9:10–9:30 AM local time in Sevilla A.
The company said the event is in person in Coral Gables, Florida (Dec 3–5) and will be webcast live with a replay available for 90 days. Entera is a clinical-stage developer of oral peptide and protein replacement therapies using its N-Tab platform; lead candidate EB613 showed positive Phase 2 biomarker and BMD results in a 161-patient study.
Entera Bio (NASDAQ: ENTX) reported Q3 2025 results and program updates on November 14, 2025. The FDA agreed that a single 24-month multinational Phase 3 of EB613 with change in total hip BMD as the primary endpoint and new/worsening vertebral fractures as key secondary would support an NDA.
Phase 2 data showed rapid gains in trabecular and cortical bone indices and consistent BMD increases in women within 10 years of menopause. Cash and cash equivalents totaled $16.6 million (including $8.0M restricted), net loss was $3.2M for Q3, and cash runway is expected through the middle of Q3 2026. GLP-2 PK showed ~15‑hour half-life (18x improvement vs teduglutide); IND for oral OXM planned H1 2026.