Primary-source record
MaterialTrial registry change
Entera Bio receives FDA feedback on EB613 Phase 3 protocol
FDA accepted the single Phase 3 study design (750 postmenopausal women, total hip BMD at 12 months) and open-label extension for EB613. The company now has a defined registrational path and expects to start the trial in late 2026 with topline results in the second half of 2028.
Key facts
- Filed
- Jun 23, 2026, 12:50 PM
- Event
- Trial registry change
- Direction
- Positive
- Company
ENTXEntera Bio- Asset
- EB613
- Source
- Company press release
- Confidence
- Sourced
- primary endpoint
- total hip BMD at 12 months
- phase3 enrollment
- 750
Source excerpt
Positive FDA Feedback on Phase 3 Brings Entera Bio's Oral Osteoporosis Pill One Step Closer to Market Entera Bio (NASDAQ: ENTX) may have just cleared its biggest regulatory hurdle yet. The FDA has provided positive feedback on the Phase 3 protocol for EB613, the company's oral osteoporosis tablet, creating a clear path toward potential approval and bringing what could become the first oral anabolic osteoporosis treatment one step closer to market. To view the original report published on June 22, 2026, click here or follow the link: https://www.benzinga.com/content/60014792/positive-fda-feedback-phase-3-entera-bio-just-got-answer-market-was-waiting NY, June 23, 2026 (GLOBE NEWSWIRE) -- CATALYST REPORT // Yesterday brought what may turn out to be the most consequential regulatory update in Entera Bio's history. Entera Bio (NASDAQ: ENTX) announced that it has received positive FDA feedback on the registrational Phase 3 protocol for EB613, its oral PTH(1-34) tablet under development for postmenopausal osteoporosis. The agency accepted the company's proposed registrational strategy: a single randomized, double-blind, placebo-controlled Phase 3 study in approximately 750 postmenopausal women, using total hip bone mineral density at 12 months as the primary endpoint to support a future New Drug Application submission. For investors who have followed the story closely, this was arguably the question that mattered most heading into the summer. Could Entera Bio translate years of cl