TEL AVIV, August 7, 2026
Entera Bio reported its second quarter 2026 financial results and business updates, highlighting regulatory progress for EB613, an investigational once-daily oral PTH(1-34) anabolic tablet being developed for postmenopausal women with osteoporosis. The company announced that the FDA has aligned with its proposed 12-month registrational Phase 3 study, which is expected to enroll approximately 750 women with osteoporosis and support a potential New Drug Application (NDA) submission. Entera plans to initiate the Phase 3 study in late 2026, with topline results anticipated in the second half of 2028. The company also secured an oversubscribed $275 million private placement, which is expected to fund EB613 through topline results and the anticipated NDA submission.
FDA Aligns with Registrational Phase 3 Study for EB613
Entera’s planned Phase 3 registrational study will be a randomized, double-blind, placebo-controlled trial evaluating EB613 in approximately 750 postmenopausal women with osteoporosis. The primary endpoint will measure the percent change from baseline in total hip bone mineral density (BMD) at Month 12. The proposed NDA package is expected to include a scientific bridge analysis comparing EB613 with Forteo® (teriparatide) under the 505(b)(2) regulatory pathway, along with a transiliac crest bone biopsy substudy. The FDA also agreed with Entera’s plan to follow participants for 24 months through an open-label extension, with additional data planned to characterize durability, safety, and treatment sequencing.
EFZO-CONNECT™ Enrollment Completed in SSc-ILD
Entera presented comparative Phase 1 data at ENDO 2026 showing that single-tablet EB613 achieved pharmacokinetic and pharmacodynamic profiles comparable to the company’s earlier multi-tablet formulation and Forteo. The study demonstrated comparable calcemic effects and consistent suppression of endogenous PTH(1-84) across the oral EB613 formulations and Forteo. These findings support the company’s decision to advance the single-tablet formulation into the planned registrational Phase 3 program. Additional Phase 2 analyses of EB613 have also been selected for a plenary poster presentation at the ASBMR 2026 Annual Meeting in October.
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$275 Million Financing Strengthens EB613 Development
Following the second quarter, Entera completed an oversubscribed $275 million private placement led by BVF Partners L.P., with participation from several institutional healthcare investors. The financing is expected to provide sufficient capital to fund the EB613 Phase 3 program through topline results and the anticipated NDA submission, while also supporting development of other pipeline programs and extending the company’s operations into 2030. Entera had $11.3 million in cash and cash equivalents and $7.1 million in restricted cash as of June 30, 2026, before the private placement proceeds.
EB612 and EB618 Expand Entera’s Oral Peptide Pipeline
Beyond EB613, Entera continues to advance additional oral peptide programs through its N-Tab® platform. EB612, an investigational long-acting oral PTH(1-34) replacement therapy for hypoparathyroidism, generated positive preclinical data across rat, minipig, and non-human primate models, showing rapid and sustained increases in serum calcium lasting approximately three days. Entera and OPKO Health intend to file an IND application in the first half of 2027. The company is also developing EB618, an oral dual GLP-1/glucagon receptor agonist based on an oxyntomodulin analog for obesity and metabolic disorders, with preclinical PK/PD data supporting continued development.
Source: Entera Bio Ltd, release
