Welcome to our dedicated page for Entera Bio news (Ticker: ENTX), a resource for investors and traders seeking the latest updates and insights on Entera Bio stock.
Entera Bio Ltd. develops orally delivered peptide and protein replacement therapies as a clinical-stage biopharmaceutical company. News about ENTX centers on its N-Tab® oral peptide platform and pipeline candidates, including EB613, an oral PTH(1-34) tablet for osteoporosis, and EB612, a long-acting oral PTH peptide replacement tablet for hypoparathyroidism.
Recurring updates also cover FDA communications and clinical-development plans, OPKO collaboration activity, financial results, private placements and warrant-linked capital actions, board and governance changes, and medical-community discussions around osteoporosis and oral anabolic therapy.
Entera Bio (NASDAQ: ENTX) received positive FDA feedback on its registrational Phase 3 protocol for EB613, an oral anabolic tablet for postmenopausal osteoporosis. The FDA accepted a single, 750-patient, placebo-controlled trial with 12‑month total hip BMD as the primary endpoint to support a potential NDA.
The NDA package is expected to include 12‑month Phase 3 data, a 24‑month open-label extension, and a 505(b)(2) scientific bridge with Forteo. A prior Phase 2 study in 161 women met primary and secondary endpoints. Phase 3 initiation is planned for late 2026, with topline data in second-half 2028.
Entera (NASDAQ:ENTX) reported preclinical ENDO 2026 data for EB612 in hypoparathyroidism and EB618 in obesity and metabolic disorders, both co-developed with OPKO Health.
EB612 and EB618 showed sustained pharmacologic effects, robust bioavailability, favorable tolerability and support advancement toward clinical development, including a planned IND for EB612 in late 2026.
Entera Bio (NASDAQ:ENTX) presented Phase 1 data at ENDO 2026 comparing single-tablet EB613, multi-tablet EB613 and injectable Forteo in 15 healthy participants.
Single-tablet EB613 showed comparable PK/PD, calcemic effects and safety to multi-tablet EB613 and Forteo, supporting selection of the single tablet as Entera’s planned Phase 3 candidate for osteoporosis.
Entera (NASDAQ:ENTX) announced that multiple abstracts from its oral peptide pipeline were accepted for presentation at ENDO 2026, June 13-16, 2026, in Chicago.
Key items include Late Breaking Oral data on EB613 for osteoporosis, plus new data on EB612 for hypoparathyroidism and EB618 for obesity and metabolic disorders.
Entera Bio (NASDAQ: ENTX) reported Q1 2026 results and clinical program updates. Cash was $11.9M at March 31, 2026 and $20.4M as of May 8, 2026 after a BVF-led private placement; available funds are expected to support operations through Q1 2027.
Key clinical milestones: EB613 Phase 3 protocol submitted to FDA for a 750-patient registrational trial; Phase 1 single-tablet bridging study completed. EB612 IND targeted in late 2026 under an expanded 50/50 OPKO partnership. EB618 and EB612 data submitted to ENDO2026/ASBMR. Corporate board changes announced.
Entera Bio (Nasdaq: ENTX) will host a virtual Key Opinion Leader webinar on April 20, 2026 at 11:00 AM ET covering the osteoporosis treatment landscape and the opportunity for its lead oral anabolic candidate, EB613 (oral PTH 1-34).
The roundtable includes CEO Miranda Toledano and experts Dr. Felicia Cosman and Dr. Steven Goldstein, and will discuss bone health around menopause, current osteoporosis care, anabolic therapies in practice, and how EB613 may fit future treatment options. Registration and a replay will be available via the company’s webcast links.
Entera Bio (Nasdaq: ENTX) closed a $10.0 million private placement on April 2, 2026, led by funds affiliated with BVF Partners L.P.
Entera sold 7,827,789 units at $1.2775 per unit; each unit includes one ordinary share (or a pre-funded warrant) and a five-year warrant to buy 1.5 shares at $1.24.
Gross proceeds were approximately $10 million, with potential additional cash of ~ $14.5 million if all warrants are exercised, for total potential proceeds of ~ $24.5 million. Net proceeds will support the planned Phase 3 registrational study of EB613 and general corporate purposes.
Entera Bio (Nasdaq: ENTX) agreed to a private placement led by BVF Partners to sell 7,827,789 units at $1.2775 per unit for gross proceeds of approximately $10.0 million, with potential additional proceeds of ~$14.5 million if warrants are exercised, for total possible proceeds of ~$24.5 million.
Each unit includes one ordinary share (or a pre-funded warrant) and a five-year warrant to buy 1.5 shares at $1.24 (an 11.7% premium to the March 31 close). Proceeds are intended to support initiation of the phase 3 EB613 registrational study and general corporate purposes.
Entera Bio (NASDAQ: ENTX) reported 2025 results and pipeline progress. Cash and equivalents were $14.9M (includes $7.8M restricted); cash runway is expected through mid‑Q3 2026. The company advanced EB613 to a streamlined Phase 3 plan, secured FDA Type A alignment on BMD as a primary endpoint, and expanded an OPKO collaboration to accelerate EB612.
Entera submitted a Phase 3 protocol amendment for EB613, expects FDA feedback in late April 2026, plans study start in late 2026 and potential topline in H2 2028.
Entera Bio (NASDAQ: ENTX) submitted a streamlined Phase 3 protocol, statistical analysis plan and 12-month open-label extension synopsis to the FDA to support an NDA for EB613 (oral teriparatide).
The multinational randomized trial targets 750 postmenopausal women with total hip BMD as the primary endpoint at month 12. Entera plans to use a single-tablet Next-Gen EB613 formulation, expects FDA feedback within 60 days, to start dosing in late 2026 and aims for topline data in H2 2028.