Entera Bio Ltd Stock Price, News & Analysis

Entera Bio Ltd (NASDAQ: ENTX) announced that CEO Spiros Jamas, Sc.D., will present a company overview at the Aegis Capital Corp. Virtual Conference on February 23, 2022, at 3:30 PM Eastern. The presentation will detail the pivotal Phase 3 study for its lead drug candidate, EB613, aimed at being the first oral bone-building drug for osteoporosis. More details here.

Entera Bio Ltd (NASDAQ: ENTX) announced plans to initiate a multi-national Phase 3 trial in 2022 for EB613, an oral formulation of human parathyroid hormone aimed at treating osteoporosis. Following a successful End-of-Phase 2 meeting with the FDA, the company confirmed that a fracture study is not required, with lumbar spine BMD at 12 months as the primary endpoint. If approved, EB613 would become the first oral anabolic osteoporosis treatment, potentially expanding patient access. With over 200 million osteoporosis patients globally, Entera anticipates significant market growth.

Entera Bio Ltd. (NASDAQ: ENTX) announced its financial results for Q3 2021, revealing revenues of $406,000, significantly up from $144,000 in Q3 2020. The Phase 2 clinical trial for EB613 showed promising results in increasing bone mineral density in osteoporosis patients, leading to plans for a Phase 3 trial in 2022. The company has a strong cash position of $27.4 million, which supports its operations through Q4 2022. Additionally, operating expenses decreased, but the net comprehensive loss widened to $17.1 million, up from $7.7 million in the same period last year.

Entera Bio Ltd. (NASDAQ: ENTX) announced promising results from preclinical in vivo studies showcasing its proprietary oral delivery technology, which demonstrates enhanced absorption for large biologic drugs. This technology underpins Entera's lead product, EB613, currently in Phase 3 clinical development for osteoporosis, with a pivotal study set for 2022. Researchers reported a significant increase in blood PTH levels using a dual mechanism combining protease inhibitors and permeation enhancers, making oral dosing a viable alternative to injections, which may improve patient compliance and treatment outcomes.

Entera Bio Ltd. (NASDAQ: ENTX) announced positive results from its completed Phase 2 trial of EB613, an oral formulation of human parathyroid hormone (PTH) aimed at treating osteoporosis. Key findings showed a significant placebo-adjusted increase of 3.78% in lumbar spine bone mineral density (BMD) after six months of treatment with the 2.5 mg dosage. Additionally, increases in BMD at the femoral neck and total hip were noted. The pivotal Phase 3 registration study is expected to commence in 2022. The safety profile was consistent with injectable PTH, with no serious adverse events reported.

Entera Bio Ltd. (NASDAQ: ENTX) announced its selection for a late-breaking oral presentation at the ASBMR Annual Meeting, showcasing results from its Phase 2 study on EB613 for treating osteoporosis in postmenopausal women. The presentation will highlight the 6-month bone mineral density (BMD) results, confirming dose-related efficacy. Scheduled for October 4, 2021, this position aims to attract interest from potential clinical investigators and prescribers. Entera is gearing up for a pivotal Phase 3 study, as CEO Spiros Jamas noted positive peer reviews enhancing the presentation's significance.

On August 23, 2021, Entera Bio Ltd. (NASDAQ: ENTX) announced its upcoming annual shareholders meeting scheduled for October 4, 2021. Entera is focused on developing orally delivered large molecule therapeutics to address unmet medical needs in areas where injectable therapies face adoption challenges. Its leading candidates, EB613 for osteoporosis and EB612 for hypoparathyroidism, are currently in clinical development. The company also collaborates with Amgen Inc. to leverage its proprietary oral delivery technology.

Entera Bio Ltd. (NASDAQ: ENTX) announced that CEO Spiros Jamas will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 3:30 pm ET. The conference runs from September 13-15, 2021, in New York. Entera focuses on innovative oral delivery systems for large molecule therapeutics, addressing significant unmet medical needs. Their lead candidates include EB613 for osteoporosis and EB612 for hypoparathyroidism, currently in clinical development. The company also collaborates with biopharma firms, including Amgen.

Entera Bio Ltd. (NASDAQ: ENTX) announced positive results from its Phase 2 clinical trial of EB613, an oral therapy for osteoporosis, achieving primary and key secondary endpoints. The trial demonstrated a 3.78% increase in lumbar spine bone mineral density after six months. The company is preparing for an End of Phase 2 meeting with the FDA to advance to a pivotal Phase 3 study, expected to start in Q2 2022. Financially, Entera reported $266,000 in revenue for the first half of 2021, with a net comprehensive loss of $14.6 million, or $0.63 per share.