Entera Bio Eyes Phase 3 Start for Oral Osteoporosis Drug EB613 After FDA Agreement
Entera Bio has reached an agreement with the FDA on a 12-month, placebo-controlled registrational trial design for its oral osteoporosis drug candidate EB613, and plans to begin a Phase 3 study.
Why it matters — The FDA agreement clears a key regulatory path for EB613, moving Entera Bio's lead candidate closer to potential approval in the osteoporosis space.