Entera Bio Unveils Promising New Clinical Results from EB613 Phase 2 Trial Showing Notable Bone Density Gains in Early Postmenopausal Women
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 23 2025
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Source: Newsfilter
EB613 Efficacy: New clinical data presented at NAMS 2025 shows that EB613, an oral anabolic treatment, significantly increases bone mineral density (BMD) in both early postmenopausal women and those more than 10 years post-menopause, addressing a critical need in osteoporosis care.
Phase 3 Study Plans: Entera Bio plans to initiate a global Phase 3 study for EB613 following FDA concurrence in July 2025, aiming to provide a first-in-class oral therapy for postmenopausal women at high risk for fractures.
Patient Access and Compliance: The oral formulation of EB613 could enhance patient access to anabolic therapy, which is often underutilized due to the challenges associated with injectable treatments, potentially transforming osteoporosis management.
Company Overview: Entera Bio is focused on developing oral peptide therapies for unmet medical needs, with EB613 being its lead candidate for osteoporosis, alongside other innovative oral treatments for various conditions.
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Analyst Views on ENTX
Wall Street analysts forecast ENTX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ENTX is 10.00 USD with a low forecast of 10.00 USD and a high forecast of 10.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
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Current: 1.470
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Current: 1.470
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About ENTX
Entera Bio Ltd is an Israel-based clinical-stage biopharmaceutical company focused on the development and commercialization of orally delivered large molecule therapeutics for use in areas with unmet medical need and where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company developed a platform that enables the oral delivery of injectable proteins and large molecules. Entera Bio candidates are EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism. Both EB613 and EB612 are oral formulations of human parathyroid hormone (1-34), or Parathormon (PTH). The products are administered via injection.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Entera Bio Plans Final EB613 Protocol Submission to FDA in Q1 2026
- FDA Submission Plan: Entera Bio plans to submit the final Phase 3 protocol for EB613 to the FDA in Q1 2026, following the FDA's broad qualification of bone mineral density as a regulatory endpoint for anti-osteoporosis drugs on December 19, 2025, which is expected to enhance the company's market position in osteoporosis.
- Clinical Study Progress: The Phase 1 bridging study for Next-Gen EB613, initiated in November 2025, is progressing on schedule with results expected by the end of Q1 2026, providing significant commercial and strategic advantages for the company.
- Accelerated Treatment Program: Entera plans to accelerate its hypoparathyroidism treatment program in 2026 based on robust preclinical PK/PD data for a proprietary long-acting PTH analog announced in late December 2025, aiming to meet the urgent market demand for new therapies.
- Strategic Partnership Discussions: The company is actively engaging in strategic partnership discussions to optimize the development and commercialization pathway for its first-in-class oral peptide programs, indicating a strong commitment to investment and innovation in areas of unmet medical needs.
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