EB612, the first oral long-acting PTH peptide replacement tablet for hypoparathyroidism, Expanded 50/50 partnership with OPKO; intention to file IND in late 2026; data submitted to ENDO2026
EB618, the first oral OXM (dual GLP-1/Glucagon) tablet for metabolic and fibrotic conditions, data submitted to ENDO2026
Direct Investment led by BVF Partners L.P. to support EB613 pivotal study acceleration and working capital
TEL AVIV, May 08, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today reported financial results and key business updates for the quarter ended March 31, 2026.
"The first quarter of 2026 solidified Entera's position as the leading oral peptide therapeutics company. Our N-Tab® platform is developing arguably the richest pipeline of clinical and near-clinical first in class assets, and we are driven by our mission to develop transformative medicines and invest in therapeutic spaces that have been ignored and require urgent attention," said Miranda Toledano, CEO of Entera.
"This begins with our EB613 journey to develop the first oral anabolic to potentially help millions of women preserve their bone health while advocating for much needed innovation in a therapeutic space which disproportionately affects the health of women. In March 2026, we submitted documents to FDA related to EB613's potential registrational package. This quarter, we also completed a critical Phase 1 bridging study for the single, final tablet formulation of EB613. Additionally, we submitted PK and TPTX proof of concept data for EB612 in hypoparathyroidism and NHP PK data for EB618 in metabolic conditions to ENDO2026 and ASBMR. Each of these milestones has been executed with a strong focus on capital efficiency by a core team that has a unifying commitment to succeed in developing therapeutics that matter," said Miranda Toledano, Chief Executive Officer of Entera.
Key Recent Highlights
EB613: First Oral PTH(1-34) Anabolic Tablet for Osteoporosis
Streamlined Phase 3 Protocol Submitted to FDA: In March 2026, Entera announced it had submitted a clinical amendment to the FDA providing a streamlined Phase 3 protocol, statistical analysis plan, and extension synopsis under its IND 505(b)(2) for EB613. The planned Phase 3 trial is designed as a multinational, randomized, double-blind, placebo-controlled safety and efficacy study in 750 postmenopausal women with osteoporosis, with percentage change in total hip bone mineral density (BMD) from baseline to month 12 as the primary outcome measure. Entera also submitted a protocol synopsis to conduct an extension study which is designed to evaluate 24 months of EB613 monotherapy treatment or 12 months of EB613 followed by 12 months of treatment with a standard anti-resorptive drug.
Next-Gen EB613 Single Tablet Advanced as Phase 3 Candidate: In January 2026, Entera completed a Phase 1 PK and safety bridging study comparing the single-tablet to the multi-tablet formulation of EB613 and Forteo® (teriparatide SC injection, Eli Lilly). Entera plans to advance the single tablet of EB613 into Phase 3. Data has been submitted as an abstract to ENDO2026.
Key Opinion Leader (KOL) Webinar on Osteoporosis Treatment Landscape: On April 20, 2026, Entera hosted a virtual KOL roundtable with Dr. Felicia Cosman (Professor of Medicine at Columbia University) and Dr. Steven Goldstein (Professor of Obstetrics and Gynecology at NYU Grossman School of Medicine and former President of both the International Menopause Society and the North American Menopause Society) to gain endocrinology and gynecology insights into how the clinician ecosystem treats osteoporosis today. The KOLs highlighted the critical unmet demand for an oral anabolic in this silent, asymptomatic disease and EB613's potential to transform the paradigm. A replay of the video is available at the following link: https://www.youtube.com/watch?v=2z6oOgwAWmg
EB612: First-in-Class Oral Long-Acting PTH(1-34) Replacement Tablet for Hypoparathyroidism
Expanded OPKO 50/50 Partnership Accelerates Path to Clinic, Funded Through Phase 1: In February 2026, Entera and OPKO amended and restated their 2025 Collaboration Agreement to advance the first oral long-acting PTH (LA-PTH) analog as a once-daily tablet for patients with hypoparathyroidism. The EB612 program has been prioritized, with an expectation to file an IND application in late 2026. TPTX and PK study data completed during the quarter have been submitted as abstracts to ENDO2026.
EB618: First-in-Class Oral Dual GLP-1/Glucagon (OXM) Tablet for Obesity and Metabolic Disease
In March 2025, Entera and OPKO announced that the potential initiation of EB618 would occur pursuant to analysis of the Phase 1 SAD/MAD studies that OPKO plans to initiate with subcutaneous once weekly injectable OXM. Pharmacokinetic data for the oral OXM tablet developed by Entera in NHP has been submitted to ENDO2026.
Corporate Highlights
Geno J. Germano Appointed Chairman of the Board: In February 2026, Mr. Germano, formerly Group President of Pfizer's Global Innovative Pharmaceutical Business, succeeded Gerald Lieberman as Chairman. Mr. Germano brings more than three decades of leadership experience across development, commercialization, and global operations at Pfizer, Wyeth, and other leading biopharmaceutical companies, and has served on the board of directors of Sage Therapeutics, Bioverativ Inc., and The Medicines Company, among others.
Steve Rubin Joined Board of Directors: In February 2026, Steve Rubin, Executive Vice President of Administration and director at OPKO, joined Entera's Board of Directors. Mr. Rubin brings three decades of experience in corporate governance and strategic oversight of drug ...
