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Form 8-K Entera Bio Ltd. For: Jul 14

Thu, 16 Jul 2026 16:07:00 -0400

si-local-file:///var/storage/secattach/20260716/26779707.html

Form 8-K Entera Bio Ltd. For: Jul 14

Thu, 16 Jul 2026 16:07:00 -0400

si-local-file:///var/storage/secattach/20260716/26779707.html

Form 4 Entera Bio Ltd. For: Jul 14 Filed by: Toledano Miranda Jayne

Thu, 16 Jul 2026 16:05:00 -0400

si-local-file:///var/storage/secattach/20260716/26779671.html

Form 4 Entera Bio Ltd. For: Jul 14 Filed by: Toledano Miranda Jayne

Thu, 16 Jul 2026 16:05:00 -0400

si-local-file:///var/storage/secattach/20260716/26779671.html

H.C. Wainwright Reiterates Buy Rating on Entera Bio (ENTX)

Wed, 24 Jun 2026 06:46:37 -0400

H.C. Wainwright analyst Raghuram Selvaraju reiterated a Buy rating and $9.00 price target on Entera Bio (NASDAQ: ENTX).

The analyst commented: "This week, Entera Bio reported that it has received positive feedback from the FDA on its Phase 3 registrational protocol for EB613 (oral PTH(1-34), teriparatide), the first oral anabolic (bone-building) tablet in development for the treatment of osteoporosis. FDA feedback is in response to a clinical amendment submitted by Entera to its Investigational New Drug (IND) application, as announced in March 2026. The agency accepted Entera’s plan to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial in approximately 750

FDA backs Entera Bio's Phase 3 trial plan for oral osteoporosis drug

Mon, 22 Jun 2026 08:30:26 -0400

Entera Bio Ltd. (NASDAQ: ENTX) said it received positive feedback from the U.S. Food and Drug Administration on its Phase 3 registrational protocol for EB613, an oral teriparatide tablet in development for postmenopausal women with osteoporosis.

The FDA accepted Entera's plan to conduct a single, randomized, double-blind, placebo-controlled Phase 3 trial in approximately 750 postmenopausal women. The primary endpoint is the percent change from baseline in total hip bone mineral density (BMD) at 12 months. Results from this trial would support a potential New Drug Application (NDA) submission for EB613 under the 505(b)(2) pathway, which includes a scientific bridge analysis comparing

Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis

Mon, 22 Jun 2026 08:30:00 -0400

The planned Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of total hip bone mineral density (BMD) at Month 12, would support Entera’s plan to submit a New Drug Application (NDA) for EB613

Entera expects to submit its NDA for EB613 based on 12-month data, with an open-label extension study to follow patients through 24 months to supplement EB613’s safety, durability of effect and sequence data

Phase 3 initiation is planned for late 2026 with topline data anticipated in the second half of 2028

TEL AVIV, June

Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis

Mon, 22 Jun 2026 08:30:00 -0400

Phase 3 initiation is planned for late 2026 with topline data anticipated in the second half of 2028

TEL AVIV, June

ENTERA BIO shares preclinical data for two pipeline drugs at ENDO 2026

Tue, 16 Jun 2026 08:33:28 -0400

Entera Bio Ltd. (NASDAQ: ENTX) presented preclinical data for two pipeline candidates, EB612 and EB618, at ENDO 2026, the annual meeting of the Endocrine Society, on June 16, 2026. Both programs are being co-developed with OPKO Health Inc. (NASDAQ: OPK) on a 50/50 basis.

EB612 is a long-acting PTH(1-34) analog formulated as an oral tablet for hypoparathyroidism. In a thyroparathyroidectomized rat model, daily dosing for seven days restored serum calcium and reduced phosphate to levels comparable to sham control animals. In a minipig model, a single oral dose reached peak plasma levels two to three hours post-dose, with drug detectable in

ENTERA BIO shares preclinical data for two pipeline drugs at ENDO 2026

Tue, 16 Jun 2026 08:33:28 -0400

ENTERA BIO shares preclinical data for two pipeline drugs at ENDO 2026

Tue, 16 Jun 2026 08:33:28 -0400

ENTERA BIO shares preclinical data for two pipeline drugs at ENDO 2026

Tue, 16 Jun 2026 08:33:28 -0400

ENTERA BIO shares preclinical data for two pipeline drugs at ENDO 2026

Tue, 16 Jun 2026 08:33:28 -0400

Entera Reports Robust Preclinical Data for EB612 (Oral LA-PTH(1-34)) for Hypoparathyroidism and EB618 (Oral GLP-1/Glucagon) for Obesity at ENDO 2026