Company: ENTXW
Filing Date: 2025-07-28
Form Type: 8-K
Source: 0001178913-25-002484
Chunk: 1

Company: Entera Bio Ltd.
Filing Date: 2025-07-28
Form: 8-K
Item: Item 8.01
Chunk 1
---
Item 8.01 Other Events.

On July 28, 2025, the Company announced that in a written response to a Type A meeting request, the U. S. Food and Drug Administration
(the “ FDA”) agreed with the Company’s proposal that the New Drug Application filing for EB613 (oral PTH (1-34), teriparatide) would be supported by a single
multinational, randomized, double-blind, placebo-controlled, 24-month phase 3 study in women with postmenopausal osteoporosis, where change in total hip Bone Mineral Density (BMD) is evaluated as the primary endpoint, and incidence of new or
worsening vertebral fractures is evaluated as the key secondary endpoint.

On June 12, 2025, Entera received a written agreement from the FDA that comprehensive nonclinical developmental and reproductive
toxicity (DART) studies are not required given the totality of evidence generated from Forteo®, published literature, and EB613 nonclinical studies.

On May 14, 2025, Entera received a written concurrence from the FDA that dedicated oral carcinogenicity studies are not warranted for
EB613 given the totality of evidence generated from the literature and nonclinical studies conducted with EB613.