---
schema_version: "secwatch.filing_event.v1"
accession: "0001178913-25-002484"
form_type: "8-K"
ticker: "ENTXW"
cik: "0001638097"
company_name: "Entera Bio Ltd."
filed_at: "2025-07-28T23:59:59+00:00"
generated_at: "2026-05-18T00:17:54.942375+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Entera Bio wins FDA agreement to use BMD as primary endpoint for EB613 Phase 3 osteoporosis study

## Summary
- FDA agreed single 24-month, placebo-controlled Phase 3 study with total hip BMD as primary endpoint; fracture incidence as key secondary.
- Shift from traditional fracture-endpoint trials; no dedicated oral carcinogenicity or DART studies required by FDA.
- Phase 3 study targets postmenopausal women; EB613 is first oral anabolic tablet for osteoporosis.
- FDA's SABRE qualification still expected later this year but not needed to proceed.
- CEO Miranda Toledano calls it a major milestone; no new osteoporosis drug approved by FDA since 2019.

## SEC filing metadata
- accession: 0001178913-25-002484
- form_type: 8-K
- ticker: ENTXW
- cik: 0001638097
- company_name: Entera Bio Ltd.
- filed_at: 2025-07-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1638097/000117891325002484/0001178913-25-002484-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1638097/000117891325002484/zk2533483.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001178913-25-002484
- JSON: https://secwatch.observer/filing/0001178913-25-002484.json
- Plain text: https://secwatch.observer/filing/0001178913-25-002484.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.