Business
Entera Bio Announces Full Year 2025 Financial Results and Provides Business Updates
EB613, the first oral anabolic (bone building) peptide tablet for postmenopausal women with osteoporosis – FDA Type A endpoint alignment in July 2025, Phase 3
About this update from Entera Bio Ltd.
[{"type":"text","content":"EB613, the first oral anabolic (bone building) peptide tablet for postmenopausal women with osteoporosis – FDA Type A endpoint alignment in July 2025, Phase 3 protocol submitted to the FDA with comments expected in early Q2 2026 EB612, the first long-acting oral PTH peptide replacement tablet for patients with hypoparathyroidism - final variants selected, pre-IND initiatives underway with intention to file IND in late 2026 in partnership with OPKO EB618, the first Oral OXM (GLP-1/Glucagon) peptide tablet for patients with metabolic syndromes – PK/PD validation complete, intention to file IND pursuant to OPKO Phase 1 SAD/MAD SC injection data TEL AVIV, March 27, 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 year ended December 31, 2025. \"2025 was a landmark year for Entera, our EB613 program and for the osteoporosis community as a whole. We are eager to initiate our important phase 3 study for EB613 and thank the investigator and patient community for their enthusiasm to take part in this mission. While current injectable anabolic or bone forming agents are accepted or accessed by a minority of osteoporosis patients in whom they should be used, our mission with EB613 is to democratize anabolic treatment. EB613 is being developed as the first oral bone building tablet so potentially, every woman and man can have the opportunity to protect their bones whether they are being treated with a primary care practitioner or a specialist,” said Miranda Toledano, Chief Executive Officer of Entera. “Throughout 2025, we also met every milestone relating to our pipeline and advanced each program with the utmost capital efficiency. Our N-Tab® oral peptide platform delivered differentiated preclinical data on LA-PTH, GLP-1/Glucagon and GLP-2 targets in partnership with OPKO Health, Inc. (“OPKO”). We believe these assets will further drive value for patients with hypoparathyroidism, metabolic syndromes and rare gastrointestinal chronic conditions.” Key Recent Highlights EB613: First Oral PTH(1-34) Anabolic Tablet for Osteoporosis Streamlined Phase 3 Protocol Submitted to FDA: In March 2026, Entera submitted a clinical amendment to the FDA providing a streamlined Phase 3 protocol, statistical a...