Phase 3 study designed with total hip BMD primary endpoint assessed at 12 months, rather than at 24 months EB613 single tablet final commercial formulation (Next-Gen EB613) replaces multi-tablet EB613 as Phase 3 candidate, following successful bridging study Topline data anticipated in the second half of 2028, approximately one year earlier than previously expected; Entera commits to a 12-month extension study to run in parallel with potential NDA review TEL AVIV, March 04, 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 the submission to the U.S. Food and Drug Administration (FDA) of a clinical amendment providing a streamlined Phase 3 protocol, statistical analysis plan (SAP), and open-label extension synopsis to the Company's Investigational New Drug (IND) 505(b)(2) submission, to evaluate EB613 (Oral PTH(1-34), teriparatide).
