ENTX

FDA Agreement on EB613: The FDA has approved Entera Bio's proposal for a Phase 3 study of EB613, focusing on bone mineral density (BMD) as the primary endpoint, which aims to support a New Drug Application for the first oral treatment for osteoporosis in post-menopausal women.

Phase 2 Data Highlights: Recent presentations at major medical conferences showcased EB613's significant efficacy in increasing both trabecular and cortical bone indices in younger post-menopausal women, indicating rapid bone strengthening comparable to existing injectable treatments.

Next-Generation EB613 and Other Programs: Entera is on track to initiate a Phase 1 trial for a next-generation version of EB613 in late 2025, while also advancing oral therapies for short bowel syndrome and obesity in collaboration with OPKO Health.

Financial Overview: For the quarter ending September 30, 2025, Entera reported a net loss of $3.2 million, with cash reserves expected to support operations through mid-2026, reflecting ongoing investments in research and development for its innovative oral peptide therapies.

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.

Encouraging Pharmacokinetic Data: Entera Bio Ltd. reported promising pharmacokinetic results for its oral GLP-2 analog therapy, OPK-8801003, aimed at treating short bowel syndrome (SBS), which could offer a more convenient alternative to the current injectable treatment, Gattex.

Market Potential and Investor Sentiment: The positive findings may enhance investor confidence in Entera's pipeline and the N-Tab oral peptide platform, as the therapy addresses a significant unmet need in a rare disease market valued at nearly $800 million annually, despite Entera's stock facing recent declines.