Entera Bio Ltd Stock Price, News & Analysis

Entera Bio Ltd. (NASDAQ: ENTX) has received FDA agreement that a single Phase 3 clinical trial can support a New Drug Application for EB613, an oral treatment for post-menopausal osteoporosis. The primary endpoint will be the change in Total Hip Bone Mineral Density (BMD). The trial involves 400 patients over 24 months, focusing on low BMD individuals without major fractures. Success in the Phase 2 study indicates potential efficacy. EB613 offers a convenient oral alternative to existing injectable therapies, representing a significant market opportunity.

Entera Bio Ltd. (NASDAQ: ENTX) will host a webinar on September 28, 2022, discussing its lead asset EB613 and its potential for osteoporosis treatment. The event features esteemed KOLs from Columbia University and Mayo Clinic, who will examine the current osteoporosis landscape and unmet needs in post-menopausal women. Entera will present Phase 2 data on EB613, a proprietary oral formulation of teriparatide, and outline its proposed Phase 3 plan submitted to the FDA. The webinar will also include a live Q&A session.

Entera Bio Ltd. (NASDAQ: ENTX) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 3:30 PM ET. The company's CEO, Miranda Toledano, will present and hold one-on-one meetings during the event. Entera specializes in developing orally delivered peptides and therapeutic proteins, focusing on addressing unmet medical needs where injectable therapies face challenges. Their advanced products include EB613 for osteoporosis and EB612 for hypoparathyroidism, with a Phase 2 study recently completed for EB613.

Entera Bio Ltd. (NASDAQ: ENTX) announced a key poster presentation at the ASBMR Annual Meeting 2022 for its Phase 2 study of EB613 (EBP05), an oral formulation of PTH for postmenopausal women with low bone mass. This study demonstrated significant correlations between EB613 dosages and blood levels, achieving primary and secondary endpoints, specifically in lumbar spine BMD after 6 months. The findings suggest EB613's potential as a convenient treatment option in osteoanabolic therapy, positioning it as a competitor to existing injectable treatments.

Entera Bio Ltd. (NASDAQ: ENTX) reported its financial results for the quarter ending June 30, 2022, showing revenues of $112,000, down from $226,000 in 2021. The company experienced an operating loss of $7.1 million and a net loss of $6.97 million, compared to $4.9 million in the same period last year. Entera holds $17.3 million in cash, sufficient to fund operations until mid-2023. Notably, the company submitted a protocol for EB613 to the FDA and is developing an optimized formulation of EB612, which may reduce administration frequency. The clinical pipeline expansion continues with new anti-inflammatory candidates.

Entera Bio Ltd. (NASDAQ: ENTX) announced the formation of a Clinical and Scientific Advisory Board (CSAB) comprised of experts in bone diseases and metabolic disorders. The company will present new data from its Phase 2 study of Oral PTH (EB613) at the ASBMR National Meeting on September 11, 2022, in Austin, Texas. The study showed significant increases in bone mineral density, particularly in postmenopausal women. CEO Miranda Toledano emphasized the importance of the CSAB's expertise in advancing Entera's clinical development strategy.

Entera Bio Ltd. (NASDAQ: ENTX) has achieved significant milestones in the development of its oral drug, EB613, for osteoporosis treatment. The FDA approved a Type C Meeting request to discuss the revised Phase 3 study, allowing for an 18-month double-blind trial aimed at assessing Bone Mineral Density (BMD) as a surrogate endpoint. The pivotal study is designed to facilitate potential approval without a fracture study. Additionally, Miranda Toledano has been appointed CEO, succeeding Dr. Spiros Jamas, to lead Entera’s strategic reorientation in pivotal clinical development.

Entera Bio Ltd. (NASDAQ: ENTX) announced the resignation of Dr. Phillip Schwartz, President of Research & Development and co-founder, effective July 21, 2022. Dr. Schwartz, who also stepped down from the Board on June 15, 2022, will continue as a consultant. He emphasized his confidence in the new management team and provided insights on Entera's pivotal drug candidates, EB613 for osteoporosis and EB612 for hypoparathyroidism, currently in clinical development. Entera aims to leverage its proprietary oral delivery technology to address significant unmet medical needs in these areas.

Entera Bio Ltd. (NASDAQ: ENTX) appointed Miranda Toledano as Chief Business Officer, Chief Financial Officer, and Head of Corporate Strategy, effective immediately. Toledano, a board member since 2018, brings nearly 25 years of experience in biotechnology and finance. Her leadership will be crucial as Entera advances its lead program, EB613, aimed at treating osteoporosis in post-menopausal women. The company aims to expand its oral delivery platform for therapeutics while collaborating with strategic partners.