EB613

June 23, 2026: Entera Bio (NASDAQ: ENTX) said it received positive FDA feedback on the registrational Phase 3 protocol for EB613, its oral PTH(1-34) (teriparatide) tablet for postmenopausal osteoporosis. The FDA accepted the company’s proposed registrational strategy of a single randomized, double-blind, placebo-controlled Phase 3 trial in ~750 postmenopausal women, with total hip bone mineral density at 12 months as the primary endpoint to support a future NDA. The agency also agreed with plans to follow patients in an open-label extension to provide additional safety, durability, and treatment-sequencing data.

Entera expects to initiate the Phase 3 study in late 2026 and anticipates topline results in 2H 2028.

The article also notes Entera presented at ENDO 2026 a Late-Breaking Oral Presentation reporting that a single-tablet version of EB613 showed pharmacokinetic/pharmacodynamic comparability to injectable Forteo and to a multi-tablet EB613 version that previously generated positive Phase 2 results.

Additional pipeline items mentioned: EB612 (oral long-acting PTH for hypoparathyroidism) and EB618 (oral GLP-1/glucagon peptide for obesity/metabolic disease), both in collaboration with OPKO Health, with new data presented at ENDO 2026.