---
schema_version: "secwatch.filing_event.v1"
accession: "0001178913-22-003937"
form_type: "8-K"
ticker: "ENTXW"
cik: "0001638097"
company_name: "Entera Bio Ltd."
filed_at: "2022-11-10T23:59:59+00:00"
generated_at: "2026-06-21T23:04:41.346982+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Entera Bio announces FDA agreement for single pivotal Phase 3 study of oral PTH tablet EB613 with BMD endpoint

## Summary
- FDA agreed that a single placebo-controlled Phase 3 study with total hip BMD as primary endpoint can support NDA for EB613.
- EB613 is the first daily oral tablet formulation of teriparatide (Forteo), targeting post-menopausal osteoporosis.
- Patient enrollment in the pivotal Phase 3 study is expected to commence in 2023.
- Q3 2022 net loss $3.1M ($0.11 per share); cash $14.3M, expected to fund operations through Q2 2023.
- Revenue was $8K (down from $140K) primarily due to finalization of Amgen pre-clinical services.

## SEC filing metadata
- accession: 0001178913-22-003937
- form_type: 8-K
- ticker: ENTXW
- cik: 0001638097
- company_name: Entera Bio Ltd.
- filed_at: 2022-11-10T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1638097/000117891322003937/0001178913-22-003937-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1638097/000117891322003937/form8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001178913-22-003937
- JSON: https://secwatch.observer/filing/0001178913-22-003937.json
- Plain text: https://secwatch.observer/filing/0001178913-22-003937.txt

## Key facts
- Earnings Releases
  Entera Bio Ltd. reported financial results for the third quarter of 2022.
  - Period: the third quarter of 2022
  - Result: reported results
  source text: Entera Bio Ltd., a company organized under the laws of the State of Israel (“we,” “us,”, “our” or the “Company”), issued a press release announcing its financial results for the three and nine months ended September 30, 2022.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1638097/000117891322003937/0001178913-22-003937-index.htm

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