Entera Bio Ltd. Ordinary Shares - ENTX STOCK NEWS

Entera Bio Ltd. (NASDAQ: ENTX) announced the acceptance of its Type D meeting protocol by the FDA, aimed at initiating a Phase 3 study of EB613, an oral therapy for osteoporosis, in H2 2023. The pivotal study will assess the impact of EB613 on bone mineral density in postmenopausal women. This study design follows FDA agreement on key elements, including the primary endpoint as Total Hip Bone Mineral Density. Entera is positioned uniquely in its field as the first company allowed to run a placebo-controlled study focusing on BMD instead of fractures. The FDA's feedback is expected by March 30, 2023, marking a critical step toward potential NDA submission.

Entera Bio Ltd. (NASDAQ: ENTX) announced its participation in the SVB Securities Global Biopharma Conference from February 13-16, 2023. The company will present on February 16 at 8:00 AM ET in Track III. Entera specializes in the development of orally delivered peptides and therapeutic proteins, particularly focusing on unmet medical needs. Its lead product candidates include EB613 for osteoporosis and EB612 for hypoparathyroidism, both in clinical development. Notably, EB613 is the first oral version of synthetic hPTH (1-34), the active ingredient of Forteo®, which generated $1.7 billion in peak sales in 2018. The corporate presentation will be archived for 90 days on their website.

Entera Bio Ltd. (NASDAQ: ENTX) reported its third-quarter 2022 financial results, revealing revenues of just $8,000, a sharp decline from $140,000 in Q3 2021. The decrease is attributed to the completion of pre-clinical R&D services for Amgen. A significant highlight includes the FDA's agreement for a pivotal Phase 3 study of EB613, the first oral PTH treatment for osteoporosis. Entera expects to initiate patient enrollment in 2023 and has cash reserves of $14.3 million, sufficient to fund operations until Q2 2023.

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.