secwatch.observer — SEC 8-K summary
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Issuer:     Entera Bio Ltd. (ENTXW)
CIK:        0001638097
Form:       8-K
Filed at:   2022-11-10T23:59:59+00:00
Accession:  0001178913-22-003937
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1638097/000117891322003937/0001178913-22-003937-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1638097/000117891322003937/form8k.htm
  HTML page:      https://secwatch.observer/filing/0001178913-22-003937

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