Entera Bio Ltd Stock Price, News & Analysis

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.

Entera Bio (Nasdaq: ENTX) reported a post-hoc analysis from its Phase 2 EB613 trial showing significant bone mineral density (BMD) gains at six months in early postmenopausal women (≤10 years since last menstrual period) presented at NAMS on Oct 23, 2025. At the 2.5 mg dose, EB613 vs placebo produced lumbar spine +3.1% (p=0.05), total hip +2.3% (p=0.03), and femoral neck +2.0% in the early postmenopausal subgroup (n=8 treated, n=19 placebo). Results were comparable to women >10 years post-menopause (femoral neck +3.2%, p=0.02; lumbar spine +2.5%, p=0.08). Entera plans a global registrational Phase 3 study after July 2025 FDA concurrence, positioning EB613 as a potential first-in-class oral anabolic option to expand access to bone-building therapy.

Entera Bio (NASDAQ: ENTX) will present new Phase 2 clinical data for EB613 at the North American Menopause Society (NAMS) 2025 Annual Meeting in Orlando, Oct 21–25, 2025.

The poster (P-66) reports six-month bone mineral density (BMD) outcomes in early postmenopausal women with low bone mass or osteoporosis, evaluating oral PTH[1-34] tablets as a potential anabolic option earlier in treatment where injectables are underutilized. Presentation is a poster session on Oct 23, 2025, 6:15–7:15 PM in Windemere Exhibit Hall.

Entera Bio (NASDAQ: ENTX) presented positive pharmacokinetic data for its first-in-class oral GLP-2 tablet (OPK-8801003) at the 2025 ESPEN Congress. The treatment, developed in collaboration with OPKO Health, aims to revolutionize care for 30,000 Short Bowel Syndrome (SBS) patients currently dependent on daily injections.

The preclinical data showed remarkable results: a 15-hour plasma half-life (18x longer than current treatment Gattex®), peak plasma concentrations of ~200 ng/ml, and sustained exposure for over 24 hours. The current GLP-2 market leader, Gattex®, generates $800 million in annual sales despite requiring daily subcutaneous injections.