Entera Bio Announces Upcoming Q1 2026 Corporate Priorities and Pipeline Outlook

Final EB613 Phase 3 Protocol Submission to FDA Planned for Q1 2026, Following December 19^th 2025 FDA Ruling

Next-Generation EB613 Phase 1 Bridging Study Progressing with Results Expected During Q1 2026                  

Oral Hypoparathyroidism Tablet Program to Accelerate with Lead Long-Acting PTH Variants

Strategic Partnership Discussions Advancing Across Pipeline

JERUSALEM, Jan. 21, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide and protein replacement therapies, today announced its expected corporate milestones for the first quarter of 2026.

“We expect to achieve three important goals during Q1 2026 to drive value for patients with osteoporosis and hypoparathyroidism. We would like to thank the investigators from around the world who participated in our Phase 3 feasibility study, and the patients who are reaching out since our FDA alignment for EB613 in July 2025. We hear  you and remain steadfast in our commitment to advance this important program back into clinic. As a Company, we continue to invest and innovate in therapeutic spaces that have been ignored, require urgent attention and practical treatments and plan to also accelerate our hypoparathyroidism program this year.  This is the second women-centric underserved condition where we believe our oral peptides can make a real difference," said Miranda Toledano, CEO of Entera.

Key Priorities and Expected Milestones for Q1 2026

EB613: First Oral PTH(1-34) Anabolic Tablet Treatment for Post-Menopausal Women with Osteoporosis
Building on Entera’s unprecedented July 29th 2025 alignment with FDA and FDA’s December 19th 2025 broad qualification of BMD as a regulatory endpoint for anti-osteoporosis drugs, Entera is planning to submit its final Phase 3 protocol to FDA in Q1 2026.

Next-Generation EB613
A Phase 1 bridging study of Next-Gen EB613 that initiated in November 2025 is progressing on schedule, with results expected by the end of Q1 2026. The Next-Gen candidate offers significant administration, commercial and strategic advantages.

EB612: Oral Long Acting PTH(1-34) Peptide Tablet for Patients with Hypoparathyroidism
Entera plans to accelerate its hypoparathyroidism program into clinic in 2026 based on robust preclinical PK/PD data for a proprietary long-acting PTH analog announced in late December 2025.