Clinical Development ProgressThe next-generation oral formulation EB613 entering clinical trials, combined with favorable pharmacokinetic and pharmacodynamic data that support filing an Investigational New Drug application, could lower development risk and improve commercial prospects.
Regulatory PathwayFDA qualification of bone mineral density as a surrogate endpoint and agreement that a single Phase 3 study using total hip BMD can support a New Drug Application reduces pivotal trial risk and clarifies the approval pathway for Entera Bio's osteoporosis candidate.
Strategic CollaborationExpanded collaboration with a larger biotechnology partner establishes equal ownership and shared development costs for an oral parathyroid hormone program, lowering Entera Bio's financial burden and supporting accelerated program advancement.