Welcome to our dedicated page for Entera Bio news (Ticker: ENTX), a resource for investors and traders seeking the latest updates and insights on Entera Bio stock.
Entera Bio Ltd. develops orally delivered peptide and protein replacement therapies as a clinical-stage biopharmaceutical company. News about ENTX centers on its N-Tab® oral peptide platform and pipeline candidates, including EB613, an oral PTH(1-34) tablet for osteoporosis, and EB612, a long-acting oral PTH peptide replacement tablet for hypoparathyroidism.
Recurring updates also cover FDA communications and clinical-development plans, OPKO collaboration activity, financial results, private placements and warrant-linked capital actions, board and governance changes, and medical-community discussions around osteoporosis and oral anabolic therapy.
Entera Bio Ltd. (NASDAQ: ENTX) has announced the appointment of Dr. Steven R. Goldstein to its Clinical and Scientific Advisory Board. Dr. Goldstein, a prominent figure in menopause research, will play a crucial role in the development of Entera's EB613 program. This innovative therapy aims to provide an oral treatment for post-menopausal osteoporosis, addressing a significant medical need in women's health. The company emphasizes the importance of actively managing bone health for post-menopausal women, especially given the high mortality rates associated with untreated osteoporosis. Entera’s EB613 is designed to be the first oral osteoanabolic therapy, offering hope for improved treatment outcomes.
Entera Bio Ltd. (NASDAQ: ENTX) announced feedback from its Type D Meeting with the FDA regarding its EB613 program for treating postmenopausal osteoporosis. The FDA accepted the use of Total Hip Bone Mineral Density (BMD) as a primary endpoint in a proposed 24-month placebo-controlled Phase 3 trial. They also affirmed the proposed pharmacokinetic study design aligns with FDA expectations. Entera CEO expressed gratitude for the FDA's support, emphasizing the potential of EB613 as the first oral osteoanabolic treatment for millions of women. The company is preparing to advance its EB612 program for hypoparathyroidism into Phase 2 by 2024.
Entera Bio Ltd. (NASDAQ: ENTX) reported its 2022 financial results, indicating significant corporate progress, particularly with its EB613 program aimed at osteoporosis treatment. Total revenues decreased to $134,000 from $571,000 in 2021, resulting in a net loss of $13.1 million, or $0.45 per share. R&D expenses also dropped to $5.8 million, while G&A expenses rose to $7.3 million due to increased compensation. Entera anticipates having sufficient cash of $12.3 million to support operations through Q3 2024 and plans to advance its EB612 program for hypoparathyroidism into Phase 2 in 2024.
Entera Bio Ltd. (NASDAQ: ENTX) announced on March 23, 2023, that it has regained compliance with NASDAQ's minimum bid price requirement. This follows a previous notification from NASDAQ on November 21, 2022, when the company failed to maintain a minimum bid price of $1.00 per share for 30 consecutive business days. Entera's ordinary shares have closed at $1.00 or higher for the last 14 consecutive business days, thus resolving the compliance issue. The company remains listed on The NASDAQ Capital Market and adheres to all applicable listing standards.
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.