secwatch.observer — SEC 8-K summary
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Issuer:     Entera Bio Ltd. (ENTXW)
CIK:        0001638097
Form:       8-K
Filed at:   2022-10-06T23:59:59+00:00
Accession:  0001178913-22-003589
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1638097/000117891322003589/0001178913-22-003589-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1638097/000117891322003589/form8k.htm
  HTML page:      https://secwatch.observer/filing/0001178913-22-003589

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