secwatch.observer — SEC 8-K summary
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Issuer:     Entera Bio Ltd. (ENTXW)
CIK:        0001638097
Form:       8-K
Filed at:   2026-03-04T23:59:59+00:00
Accession:  0001178913-26-000714
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1638097/000117891326000714/0001178913-26-000714-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1638097/000117891326000714/zk2634484.htm
  HTML page:      https://secwatch.observer/filing/0001178913-26-000714

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer