Entera Bio submits streamlined Phase 3 protocol to U.S. FDA for EB613

Entera Bio (ENTX) announced the submission to the U.S. Food and Drug Administration of a clinical amendment providing a streamlined Phase 3 protocol, statistical analysis plan, and open-label extension synopsis to the Company’s Investigational New Drug (IND) 505(b)(2) submission, to evaluate EB613. Entera anticipates FDA feedback within 60 days. The Company expects to initiate the Phase 3 study in late 2026, with topline results anticipated in the second half of 2028 – approximately one year earlier than previously expected. “This submission marks a pivotal inflection point for Entera and potentially enables us to get EB613 to patients faster,” said Miranda Toledano, Chief Executive Officer of Entera. “Our goal with EB613 is to democratize anabolic treatment and enable millions of women and men to protect their bones earlier and potentially deter the catastrophic consequences of fracture. In a silent and asymptomatic disease, access and ease of administration matters.”