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. (ENTX) is a biotechnology firm based in Israel, specializing in the development of orally delivered macromolecule therapeutics. These include peptides and therapeutic proteins aimed at treating chronic medical conditions with an unmet need. The company’s innovative approach focuses on oral administration, which has the potential to significantly change treatment paradigms.
Entera Bio's leading product candidates include EB613 and EB612. EB613 is designed to treat osteoporosis in a once-daily, oral mini tablet form of synthetic human PTH (1-34) (teriparatide). It has shown promising results in Phase 2 clinical trials, meeting both primary and secondary endpoints. Entera Bio plans to initiate a Phase 3 study for EB613 in 2024, following FDA guidelines. EB612 is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism.
Beyond these, Entera Bio is advancing several other oral peptide therapies. These include an oral oxyntomodulin tablet for obesity and an oral GLP-2 peptide tablet for rare malabsorption conditions like short bowel syndrome, in collaboration with OPKO Health.
Entera Bio leverages a proprietary technology platform that boosts the oral bioavailability of peptides, making them effective alternatives to injectable therapies. This platform is pivotal in their ongoing projects and future pipeline products, which they aim to bring to clinical phases by 2025.
In terms of financials, Entera Bio has demonstrated robust performance, as reflected in their latest financial results for the year ending December 31, 2023. The company continues to focus on strategic partnerships and advancing their research to fulfill significant unmet medical needs.
For the latest updates and news about Entera Bio Ltd., including their latest product developments and financial results, visit Entera Bio's official website.
Entera Bio (NASDAQ: ENTX) announced that two abstracts related to EB613, their oral PTH(1-34) tablet treatment for post-menopausal osteoporosis, have been accepted for presentation at the WCO-IOF-ESCEO congress in Rome (April 10-13, 2025). The presentations will focus on the effects of EB613 on trabecular and cortical bone using 3D-DXA, and its impact on bone modeling versus remodeling.
In a Phase 2 placebo-controlled study, EB613 demonstrated rapid onset and significant BMD increases across all skeletal sites over 6 months, along with increased bone formation (P1NP) and reduced bone resorption (CTX). The treatment is being developed as the first once-daily oral anabolic therapy for high-risk post-menopausal women with osteoporosis, targeting a condition that affects an estimated 200 million women globally.
Entera Bio (NASDAQ: ENTX), a pioneer in oral peptide and therapeutic protein delivery, has announced its participation in the upcoming Oppenheimer 35th Annual Healthcare Life Sciences Conference. The virtual event is scheduled for February 11-12, 2025.
The company's CEO, Miranda Toledano, will deliver a business overview and update presentation on Tuesday, February 11th from 12:40-1:10 PM ET in Track 1. The company will also be available for investor meetings throughout the conference.
Entera Bio reported Q3 2024 financial results and updates on its oral peptide development programs. The company's lead asset, EB613, is advancing as the first oral PTH(1-34) tablet for post-menopausal women with high-risk osteoporosis. Key developments include positive pharmacokinetic results for their GLP-1/Glucagon program with OPKO Health and ongoing development of oral GLP-2 tablets. Financial highlights show cash position of $6.9 million, R&D expenses of $1.5 million, and a net loss of $3.0 million ($0.08 per share). The company expects current cash to fund operations into Q3 2025.
Entera Bio (NASDAQ: ENTX) and OPKO Health, Inc. (NASDAQ: OPK) have announced positive results from their collaborative research on an oral oxyntomodulin (OXM) peptide tablet for obesity and metabolic disorders. The study, combining OPKO's proprietary long-acting OXM analog with Entera's N-Tab™ technology, aims to develop the first oral dual agonist GLP-1/glucagon peptide for once-daily treatment.
Key findings from the in vivo proof-of-concept PK/PD studies in rodent and pig models include:
- Significant systemic exposure following a single dose
- Favorable PK profile and bioavailability
- High plasma concentrations with prolonged systemic exposure in pigs
- Statistically significant reduction in plasma glucose levels in rats
The companies plan to present these data at an upcoming clinical conference and move towards IND-enabling efforts for the program.
Entera Bio (NASDAQ: ENTX), a leader in developing orally delivered peptides and small therapeutic proteins, has announced its participation in three upcoming conferences:
1. H.C. Wainwright 26th Annual Global Investment Conference: Virtual presentation on September 9, 2024, at 7am ET.
2. American Society for Bone and Mineral Research 2024 Annual Meeting: In-person poster presentation on September 28, 2024, from 2:15 – 3:45PM in Toronto, Canada.
3. 7th Annual Evercore ISI HealthCONx Conference: In-person fireside chat on December 4, 2024, from 3:25-3:45PM in Coral Gables, Florida.
These conferences provide Entera Bio with opportunities to showcase its developments and engage with investors and scientific communities.
Entera Bio (NASDAQ: ENTX) reported Q2 2024 financial results and provided business updates. Key highlights include:
1. Advancing EB613, the first oral PTH(1-34) daily osteoanabolic tablets for osteoporosis, with new comparative data vs. Forteo® to be presented at ASBMR 2024.
2. Progress on EB612, the first oral PTH(1-34) peptide replacement therapy for hypoparathyroidism, with Phase 1 data supporting potential Phase 2 development.
3. Positive in vivo PK results for GLP-2 peptide tablets for short bowel syndrome, with pharmacology data expected in H2 2024.
4. Ongoing development of GLP-1/Glucagon agonist tablets for obesity, with PK data expected in H2 2024.
5. Financial results: $9.1M cash on hand, sufficient until Q3 2025. Q2 2024 net loss of $2.1M ($0.06 per share) compared to $2.3M ($0.08 per share) in Q2 2023.
Entera Bio (NASDAQ: ENTX) announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® will be presented at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting. EB613 is being developed as the first once-daily oral anabolic PTH(1-34) mini tablet therapy for post-menopausal women with high-risk osteoporosis.
The company aims to address the treatment gap in current osteoporosis care, targeting the estimated 200 million women globally affected by post-menopausal osteoporosis. Entera also anticipates a key update from the SABRE (Study to Advance BMD as a Regulatory Endpoint) project at the meeting, following the FDA's communication about qualifying bone mineral density (BMD) as a surrogate endpoint for fractures in future osteoporosis drug trials.
Entera Bio announced promising Phase 1 clinical data for its oral PTH(1-34) peptide candidate, EB612, aimed at treating hypoparathyroidism. Presented at the ENDO 2024 Annual Meeting, the study showcased significant systemic exposure and sustained pharmacodynamic effects, including improved serum levels of calcium, phosphate, and Vitamin D. The treatment showed a favorable safety profile, with no serious adverse events reported and only minor side effects such as mild headaches in two subjects. The findings suggest that EB612, administered twice daily, could be a viable alternative to current injectable therapies.
Entera Bio (NASDAQ: ENTX) has announced the appointment of Dr. Rachel B Wagman as Key Clinical Advisor and Member of its Scientific Advisory Board. Dr. Wagman brings over 20 years of experience in metabolic bone disease and women's health research, including the successful development of five molecules such as teriparatide (Forteo®), denosumab (Prolia®), and romosozumab (Evenity®). Her appointment is expected to enhance Entera's oral peptide pipeline focused on chronic metabolic disorders. CEO Miranda Toledano highlighted Dr. Wagman's patient-focused approach and therapeutic specializations. Dr. Wagman expressed her commitment to innovative treatments, particularly in osteoporosis. Her past roles include senior positions at Eli Lilly, Amgen, and Myovant Sciences.
Entera Bio (NASDAQ: ENTX) will present Phase 1 data on their investigational program EB612 at the ENDO 2024 Annual Meeting. EB612 aims to provide an oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. The study focuses on reducing daily administration frequency by using Entera's N-Tab™ technology platform.
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