---
schema_version: "secwatch.filing_event.v1"
accession: "0001178913-22-003589"
form_type: "8-K"
ticker: "ENTXW"
cik: "0001638097"
company_name: "Entera Bio Ltd."
filed_at: "2022-10-06T23:59:59+00:00"
generated_at: "2026-06-23T05:04:00.598262+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Entera Bio receives FDA agreement that single Phase 3 study could support NDA for EB613

## Summary
- FDA agreed single Phase 3 placebo-controlled trial could support NDA for oral teriparatide EB613 via 505(b)(2) pathway.
- Primary endpoint: change in Total Hip BMD at 24 months in post-menopausal osteoporosis patients.
- Planned 400 EB613 patients with 2:1 randomization; eligible patients BMD T-score ≤-2.5 to 3.0, no major fracture history.
- Company to submit relative PK data comparing oral EB613 to subcutaneous Forteo.
- Expects to initiate Phase 3 enrollment in 2023.

## SEC filing metadata
- accession: 0001178913-22-003589
- form_type: 8-K
- ticker: ENTXW
- cik: 0001638097
- company_name: Entera Bio Ltd.
- filed_at: 2022-10-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1638097/000117891322003589/0001178913-22-003589-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1638097/000117891322003589/form8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001178913-22-003589
- JSON: https://secwatch.observer/filing/0001178913-22-003589.json
- Plain text: https://secwatch.observer/filing/0001178913-22-003589.txt

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