EB613

August 7, 2026: Entera Bio Ltd. (NASDAQ: ENTX) reported multiple pipeline catalysts. For EB613, an oral PTH(1-34) tablet for postmenopausal women with osteoporosis, the FDA agreed in June 2026 to a single randomized, double-blind, placebo-controlled registrational Phase 3 trial in about 750 patients, using percent change in total hip BMD at Month 12 as the primary endpoint to support a potential NDA under the 505(b)(2) pathway with a scientific bridge to Forteo. A bone biopsy substudy and 24-month open-label extension are planned; Entera expects Phase 3 initiation in late 2026 and topline data in 2H 2028. Also for EB613, Phase 1 data presented at ENDO 2026 showed single-tablet PK/PD comparable to prior multi-tablet EB613 and Forteo; new Phase 2 analysis was selected for ASBMR 2026 (Oct. 9-12, 2026).

For EB612, an oral long-acting PTH(1-34) tablet for hypoparathyroidism, preclinical ENDO 2026 data showed oral bioavailability and serum calcium increases lasting about three days across rat, minipig, and non-human primate models; IND filing with OPKO is planned for 1H 2027.

For EB618, an oral GLP-1/glucagon agonist, non-human primate ENDO 2026 data showed dose-proportional exposure and glucose effects; further clinical development will be evaluated after OPKO’s injectable Phase 1 SAD/MAD studies.

Entera also disclosed an oversubscribed $275 million private placement in July 2026 expected to fund EB613 through anticipated NDA submission and support operations into 2030.