Entera Bio submits streamlined Phase 3 protocol for EB613 to FDA; topline data H2 2028

Entera Bio Ltd.

Phase 3 trial to enroll 750 postmenopausal women with osteoporosis; primary endpoint total hip BMD at 12 months.
Single tablet final commercial formulation (Next-Gen EB613) replaces multi-tablet candidate; no bridging needed.
FDA feedback expected within 60 days; topline results anticipated in second half of 2028, one year earlier than prior guidance.
12-month open-label extension study submitted; will run in parallel with potential NDA review.

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