Entera Bio Advances Phase 3 EB613 Osteoporosis Tablet With FDA Protocol Submission Planned for Q1 2026

Reuters
Jan 21
Entera Bio Advances Phase 3 EB613 Osteoporosis Tablet With FDA Protocol Submission Planned for Q1 2026

Entera Bio Ltd. has announced several upcoming milestones for the first quarter of 2026 related to its oral peptide and protein replacement therapy pipeline. The company plans to submit the final Phase 3 protocol for EB613, its oral PTH(1-34) anabolic tablet for post-menopausal women with osteoporosis, to the FDA in Q1 2026, following recent regulatory developments. Additionally, a Phase 1 bridging study of the next-generation EB613, which began in November 2025, is progressing on schedule, with results expected by the end of Q1 2026. Entera Bio also intends to accelerate its oral hypoparathyroidism tablet program, moving its lead long-acting PTH analog into clinical development in 2026. Results from the ongoing studies have not yet been presented but are anticipated in the near future.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Entera Bio Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001160243-en) on January 21, 2026, and is solely responsible for the information contained therein.

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