Entera Bio Q1 2026: EB613 Oral PTH(1-34) Tablet Phase 3 Plan Submitted to FDA, 750-Patient Postmenopausal Osteoporosis Trial Slated for Late 2026, Topline H2 2028
Entera Bio reported Q1 2026 May 8 with $20.4M cash and an updated Phase 3 plan for EB613, an oral once-daily PTH(1-34) tablet that would be the first oral osteoanabolic for postmenopausal osteoporosis. The streamlined Phase 3 protocol — submitted to the FDA in March — covers 750 postmenopausal women with primary endpoint of total hip BMD change from baseline at month 12. Trial initiation is targeted for late 2026, with topline H2 2028 — roughly one year earlier than previously guided. The molecule applies Entera's N-Tab oral peptide platform to teriparatide, the active ingredient in Forteo. The Phase 2 dose-ranging study in 161 patients met primary (PD/bone-turnover biomarker) and secondary (BMD) endpoints.