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Form 8-K Entera Bio Ltd. For: Mar 04

Wed, 04 Mar 2026 09:01:00 -0500

si-local-file:///var/storage/secattach/20260304/26108045.html

Form 8-K Entera Bio Ltd. For: Mar 04

Wed, 04 Mar 2026 09:01:00 -0500

si-local-file:///var/storage/secattach/20260304/26108045.html

Entera Bio submits streamlined Phase 3 protocol for oral osteoporosis drug

Wed, 04 Mar 2026 08:30:11 -0500

Entera Bio Ltd. (NASDAQ: ENTX) submitted a streamlined Phase 3 protocol to the U.S. Food and Drug Administration for its oral osteoporosis treatment EB613. The company anticipates FDA feedback within 60 days.

The planned Phase 3 trial will evaluate EB613 in 750 postmenopausal women with osteoporosis, measuring changes in total hip bone mineral density at 12 months rather than the previously planned 24 months. This adjustment reduces the required enrollment compared to previous development assumptions.

Entera will advance a single tablet formulation of EB613 directly into Phase 3, replacing the previous multi-tablet version. The company completed a bridging study to support this

Entera Bio Submits Streamlined Phase 3 Protocol to Initiate Registrational Program for EB613 in Postmenopausal Women with Osteoporosis

Wed, 04 Mar 2026 08:30:00 -0500

Phase 3 study designed with total hip BMD primary endpoint assessed at 12 months, rather than at 24 months

EB613 single tablet final commercial formulation (Next-Gen EB613) replaces multi-tablet EB613 as Phase 3 candidate, following successful bridging study

Topline data anticipated in the second half of 2028, approximately one year earlier than previously expected; Entera commits to a 12-month extension study to run in parallel with potential NDA review

TEL AVIV, March 04, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide

Entera Bio Submits Streamlined Phase 3 Protocol to Initiate Registrational Program for EB613 in Postmenopausal Women with Osteoporosis

Wed, 04 Mar 2026 08:30:00 -0500

Phase 3 study designed with total hip BMD primary endpoint assessed at 12 months, rather than at 24 months

EB613 single tablet final commercial formulation (Next-Gen EB613) replaces multi-tablet EB613 as Phase 3 candidate, following successful bridging study

TEL AVIV, March 04, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide

Entera Bio to Participate in the Leerink Partners 2026 Global Healthcare Conference

Thu, 26 Feb 2026 08:00:00 -0500

TEL AVIV, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide and protein replacement therapies, today announced that the Company’s Chief Executive Officer, Miranda Toledano, will be participating in a fireside chat at the Leerink Partners Global Healthcare Conference 2026, details as below.

Leerink Partners Global Healthcare Conference 2026 (Fireside Chat and 1x1 Meetings)