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) 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.
Entera Bio Ltd. (NASDAQ: ENTX) has commenced the registrational study design for its lead clinical asset, EB613, an oral treatment for post-menopausal women at high risk of osteoporosis. The FDA has completed its review of the Chemistry Manufacturing and Control for EB613, paving the way for a pivotal Phase 3 trial. Financially, Entera reported a revenue drop to $68,000 for Q1 2022, down from $157,000 in Q1 2021, while operating expenses rose to $3.8 million, leading to a net loss of $3.8 million, or $0.13 per share. The company has cash reserves of $20.1 million as of March 31, 2022.
Entera Bio Ltd (NASDAQ: ENTX) announced the filing of multiple U.S. patent applications to bolster its intellectual property and support future development of its oral delivery platform technology. This technology aims to enhance bioavailability and reduce drug costs compared to existing oral delivery systems for peptides. Additionally, the company is focusing on specific molecules, such as parathyroid hormone and glucagon-like peptides, for various therapeutic indications. CEO Spiros Jamas highlighted the potential for strategic partnerships to advance their innovations.
Entera Bio Ltd (NASDAQ: ENTX) will report its business and financial results for Q1 2022 on May 12, 2022, at 8:30 AM EDT. The company focuses on developing orally delivered large-molecule therapeutics to address significant unmet medical needs. Entera's advanced candidates include EB613 for osteoporosis and EB612 for hypoparathyroidism, which are currently in clinical development. The company also collaborates with biopharmaceutical firms, including Amgen Inc., licensing its proprietary drug delivery technology.
Entera Bio Ltd (NASDAQ: ENTX), a pioneer in orally delivered large molecule therapeutics, announced its participation in the Maxim Virtual Growth Conference on March 30, 2022, at 10:30 AM EDT, featuring a fireside chat format.
Following the event, a webcast replay will be accessible on Entera's investor relations website. Entera focuses on addressing unmet medical needs with its cutting-edge oral drug delivery technology, particularly for osteoporosis and hypoparathyroidism. The company recently completed a phase 2 study for its lead candidate, EB613.