Entera Bio Ltd Stock Price, News & Analysis

Entera Bio (NASDAQ:ENTX) reported significant progress in Q2 2025, highlighted by FDA's agreement on using Bone Mineral Density (BMD) as the primary endpoint for EB613's Phase 3 program - a potential first oral anabolic osteoporosis treatment. The FDA also waived requirements for additional safety studies, streamlining the regulatory pathway.

The company maintains a strong financial position with $18.9 million in cash, including $8.0 million restricted for OPKO collaboration, providing runway through mid-Q3 2026. Q2 resulted in a net loss of $2.7 million ($0.06 per share), compared to $2.1 million in Q2 2024.

Pipeline developments include promising preclinical data for their obesity program with OPKO, featuring oral GLP-1/glucagon dual agonist showing comparable plasma levels to Wegovy™. Additionally, their next-generation EB613 is expected to enter Phase 1 trials in November 2025.

Entera Bio (NASDAQ: ENTX) has received FDA agreement on using Bone Mineral Density (BMD) as the primary endpoint for its Phase 3 study of EB613, an oral treatment for post-menopausal osteoporosis. The FDA approved a 24-month phase 3 study design where total hip BMD will be the primary endpoint, with vertebral fractures as a secondary endpoint.

This represents a significant shift from traditional osteoporosis drug trials that required fracture incidence as the primary endpoint. The development aims to create the first oral, once-daily anabolic tablet for osteoporosis treatment, addressing a market of over 200 million women globally who suffer from the condition.

Entera Bio (NASDAQ: ENTX) and OPKO Health (NASDAQ: OPK) announced their abstract on oral GLP-2 tablet treatment for Short Bowel Syndrome (SBS) has been selected for presentation at the 47th ESPEN Congress in Prague (September 13-16, 2025).

The program combines OPKO's proprietary long-acting GLP-2 agonist with Entera's N-Tab™ technology, aiming to provide an oral alternative to GATTEX® (teduglutide), which currently requires daily subcutaneous injections. The oral tablet format could potentially improve treatment compliance and enable more personalized care for SBS patients.

Entera Bio (NASDAQ: ENTX) announced that new data for its EB613 oral PTH(1-34) tablet for osteoporosis treatment will be presented at the ASBMR 2025 Annual Meeting. The Phase 2 study involved 161 postmenopausal women with low bone mass or osteoporosis, testing four dose levels against placebo for 6 months.

The study demonstrated that EB613 significantly increased BMD at measured skeletal sites compared to baseline and placebo, with biochemical markers suggesting dual effects of stimulating formation and inhibiting bone resorption. The company aims to develop EB613 as the first once-daily oral anabolic treatment for postmenopausal women with high-risk osteoporosis.

Entera Bio (NASDAQ: ENTX) and OPKO Health (NASDAQ: OPK) announced their abstract for oral OPK-88006, a first-in-class dual GLP-1/glucagon agonist tablet, has been selected for presentation at ENDO 2025 in San Francisco. The drug candidate, developed through their collaboration, is being advanced as both a once-daily tablet and a weekly subcutaneous injection for treating obesity and metabolic disorders.

The oral formulation combines OPKO's long-acting oxyntomodulin analog with Entera's N-Tab™ technology. The companies plan to file an IND application with the FDA later in 2025 for both formulations, followed by Phase 1 clinical studies.

Entera Bio (NASDAQ: ENTX) reported Q1 2025 financial results and business updates. The company's cash position stands at $20.6 million, expected to fund operations through Q3 2026. Key developments include: 1) Progress on EB613, their oral PTH tablet for osteoporosis, with positive 3D-Shaper analysis data selected for presentation at WCO Congress. 2) Partnership with OPKO Health to co-develop Oral OPK-88006, a dual GLP1/Glucagon tablet for metabolic diseases, with Entera retaining 40% stake. 3) Q1 2025 financial results showed R&D expenses of $1.1M (up from $0.7M in Q1 2024) and G&A expenses of $1.4M (up from $1.3M). Net loss was $2.6M or $0.06 per share. 4) Key appointments include Leslie Gautam as Chief Business Officer and Cherin Smith as Head of Clinical Operations. The company plans to initiate Phase 1 study for Next Gen EB613 in H2 2025.

Entera Bio (NASDAQ: ENTX) presented promising Phase 2 study results for EB613, their innovative once-daily oral PTH(1-34) tablet for postmenopausal osteoporosis treatment, at the 2025 WCO-IOF-ESCEO Congress in Rome.

The study involving 161 postmenopausal women demonstrated that after 6 months of treatment, EB613 showed significant improvements in bone mineral density (BMD) compared to placebo. The 3D-DXA analysis revealed increases in integral volumetric BMD, trabecular volumetric BMD, cortical thickness, and cortical surface BMD.

The results indicate early beneficial effects on both trabecular and cortical bone of the proximal femur, suggesting potential rapid bone strengthening and fracture resistance. This development is particularly significant as postmenopausal osteoporosis affects an estimated 200 million women globally, with 50% of women over 50 at risk of fragility fractures.

Entera Bio (NASDAQ: ENTX) reported its financial results for 2024, marking a transformational year in developing oral peptide therapies. The company's flagship product, EB613, the first oral PTH(1-34) tablet for osteoporosis, made significant progress with published Phase 2 trial results in JBMR.

Key developments include successful results in their GLP-1/Glucagon program with OPKO Health, showing significant systemic exposure and glucose reduction. The company also advanced their GLP-2 peptide tablets program for Short Bowel Syndrome, demonstrating 10-fold higher plasma levels compared to existing treatments.

Financial highlights: Cash position of $21 million as of March 2025, sufficient until Q3 2026. R&D expenses remained stable at $4.5 million, while G&A expenses increased to $5.1 million. Net loss for 2024 was $9.5 million ($0.25 per share) compared to $8.9 million ($0.31 per share) in 2023.

OPKO Health (NASDAQ: OPK) and Entera Bio (NASDAQ: ENTX) have formed a collaboration agreement to develop the first oral dual agonist GLP-1/glucagon peptide tablet for treating obesity and metabolic disorders. The program combines OPKO's OPK-88006 with Entera's N-Tab™ technology, following favorable data reported in September 2024.

The partnership structure gives OPKO a 60% ownership stake and Entera a 40% stake, with corresponding cost-sharing responsibilities. OPKO has purchased 3,685,226 Entera shares at $2.17 per share, with proceeds funding Entera's Phase 1 development costs. Post-Phase 1, Entera can maintain its 40% stake by continuing funding, or opt-out to retain 15% ownership while OPKO increases to 85%.

The companies plan to file an Investigational New Drug application with the FDA later this year. The treatment utilizes oxyntomodulin, a natural hormone that suppresses appetite, induces weight loss, and offers cardioprotective and anti-fibrotic benefits. Currently, no approved dual GLP-1/Glucagon agonists exist in the market.