---
schema_version: "secwatch.filing_event.v1"
accession: "0001178913-26-000714"
form_type: "8-K"
ticker: "ENTXW"
cik: "0001638097"
company_name: "Entera Bio Ltd."
filed_at: "2026-03-04T23:59:59+00:00"
generated_at: "2026-05-15T21:41:33.015365+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Entera Bio submits streamlined Phase 3 protocol for EB613 to FDA; topline data H2 2028

## Summary
- Phase 3 trial to enroll 750 postmenopausal women with osteoporosis; primary endpoint total hip BMD at 12 months.
- Single tablet final commercial formulation (Next-Gen EB613) replaces multi-tablet candidate; no bridging needed.
- FDA feedback expected within 60 days; topline results anticipated in second half of 2028, one year earlier than prior guidance.
- 12-month open-label extension study submitted; will run in parallel with potential NDA review.

## SEC filing metadata
- accession: 0001178913-26-000714
- form_type: 8-K
- ticker: ENTXW
- cik: 0001638097
- company_name: Entera Bio Ltd.
- filed_at: 2026-03-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1638097/000117891326000714/0001178913-26-000714-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1638097/000117891326000714/zk2634484.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001178913-26-000714
- JSON: https://secwatch.observer/filing/0001178913-26-000714.json
- Plain text: https://secwatch.observer/filing/0001178913-26-000714.txt

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