Entera Bio Gets FDA Nod for Single Phase 3 Trial of First Oral Osteoporosis Tablet

Regulation
โดย GlobeNewswire·Read original
Summary · why it matters

Entera Bio has received positive FDA feedback on its Phase 3 protocol for EB613, the first oral anabolic tablet in development for postmenopausal osteoporosis. The FDA accepted a single randomized, double-blind, placebo-controlled trial in approximately 750 postmenopausal women, with total hip bone mineral density at 12 months as the primary endpoint, to support a New Drug Application under the 505(b)(2) pathway. The company plans to initiate the study in late 2026 and expects topline data in the second half of 2028, with an open-label extension following patients through 24 months to provide additional safety and durability data.

Impact on stocks 1

Health Care▲ · 1 stocks
© 2026 MarketDXNews