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

Entera Bio Ltd.

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.

item 2.02 item 7.01 item 9.01

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Entera Bio Ltd. reported financial results for the third quarter of 2022.

Period: the third quarter of 2022
Result: reported results

Exact text from the filing

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.

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Source: SEC EDGAR

accession 0001178913-22-003937

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