Entera Bio (ENTX) received positive feedback from the US Food and Drug Administration on the proposed Phase 3 registrational study design for EB613, its oral osteoporosis therapy for postmenopausal women, the company said Monday.

The company said the planned study will enroll about 750 patients, with the percent change in total hip bone mineral density at 12 months serving as the primary endpoint to support a potential New Drug Application filing.

Entera said the FDA endorsed its proposed 24-month open-label extension study and accepted the overall registrational strategy, including a planned NDA submission based on 12-month data, supplemented by longer-term safety follow-up.

The company expects to begin the Phase 3 trial in late 2026 and report topline results in the second half of 2028.