Entera Bio Ltd.

Entera Appoints Global Research and Development Leader Dr. Juan Camilo Arjona Ferreira to Its Board of Directors

Entera Bio appointed Dr. Juan Camilo Arjona Ferreira, currently Head of R&D and Chief Medical Officer at Organon, to its Board of Directors effective December 1, 2026, succeeding outgoing director Haya Taitel. He brings two decades of clinical development and regulatory experience in women's health across Organon, Myovant, Shionogi and Merck, which aligns with Entera's lead program EB613 in late-stage development for osteoporosis and EB612 entering early clinical development for hypoparathyroidism. The appointment is a modest credibility boost for the clinical-stage biotech but carries no near-term financial impact.

•5d ago

Entera Presents Markedly Enhanced Anabolic Effects of EB613 (First-in-Class Oral PTH(1-34) Tablet) in Postmenopausal Women with Osteoporosis at High Risk of Fracture and Showcases Phase 3 Design at ASBMR 2026 Annual Meeting

Entera Bio presented post-hoc Phase 2 data at ASBMR 2026 showing stronger anabolic effects of EB613, its first-in-class oral PTH(1-34) tablet, in postmenopausal women with osteoporosis (T-score ≤-2.5) versus osteopenia. Placebo-adjusted BMD gains at 6 months were 4.23% at total hip and 4.22% at lumbar spine in the osteoporosis subgroup, versus roughly 1-1.6% in higher-T-score patients, supporting the Phase 3 target population. The company also detailed its registrational Phase 3 design: a multinational, randomized, double-blind, placebo-controlled study of about 900 postmenopausal women randomized 2:1 to EB613 or placebo for 12 months, with Month 12 total hip BMD as the primary endpoint. Management framed the analysis as derisking the Phase 3 thesis; EB613 would be the first oral anabolic tablet for osteoporosis if approved.

•19d ago

Entera Bio Announces Additional Presentation of EB613 Phase 3 Study Design at the ASBMR 2026 Annual Meeting

Entera Bio announced an additional late-breaking poster presentation at the ASBMR 2026 Annual Meeting (Oct 9-12, Boston) outlining the study design for its planned single Phase 3 registrational trial of EB613, an oral PTH(1-34) tablet for postmenopausal osteoporosis. The presentation, led by osteoporosis authority Dr. Felicia Cosman of Columbia University, joins the company's previously accepted Plenary Poster of Phase 2 data, in which the 161-patient, 6-month study met all biomarker and BMD endpoints. The announcements raise the profile of EB613 ahead of the Phase 3 launch but contain no new clinical data; the risk-factor section also flags going-concern liquidity and Nasdaq listing-compliance risks.

•24d ago

Entera Appoints Global BioPharma Executive Laura Hamill to Its Board of Directors, Expanding Commercial Expertise

Entera Bio appointed Laura Hamill, a former Gilead and Amgen commercial executive with over 35 years of experience, to its Board of Directors effective December 1, 2026. Hamill most recently led Gilead's worldwide commercial operations, overseeing roughly 2,500 employees and $22 billion in annual revenue, after nearly two decades at Amgen. The appointment adds commercial launch expertise as Entera advances its lead oral PTH(1-34) candidate EB613 toward potential commercialization in osteoporosis; she succeeds long-serving director Yonatan Malca.

•26d ago

Entera Appoints Global Pharmaceutical Leader Riccardo Paolo Camisasca, M.D., as Chief Medical Officer Ahead of Planned EB613 Phase 3 Initiation

Entera Bio appointed Dr. Riccardo Paolo Camisasca as Chief Medical Officer, bringing over 30 years of global pharmaceutical experience from companies including Sumitomo Pharma, Takeda, and Novartis. The strategic hire strengthens the clinical leadership team as the company prepares for the planned Phase 3 initiation of EB613, its lead oral treatment for osteoporosis. Management highlighted Dr. Camisasca's expertise in late-stage development and regulatory strategy as critical for advancing the broader oral peptide pipeline.

•2mo ago

Entera Announces Second Quarter 2026 Financial Results and Business Updates

Entera Bio announced a transformational oversubscribed $275 million private placement led by BVF, securing capital to fund its Phase 3 registrational program for EB613 and extending its cash runway into 2030. The company confirmed FDA alignment on a single 12-month Phase 3 study for EB613 in postmenopausal osteoporosis, with topline data anticipated in the second half of 2028, and reported positive data for its EB612 and EB618 candidates. For the second quarter of 2026, the company reported a net loss of $7.3 million, or $0.14 per share, compared to a loss of $2.7 million, or $0.06 per share, in the prior year, driven by increased R&D expenses and a non-cash warrant remeasurement.

•2mo ago

Entera Bio Phase 2 Data Supporting EB613’s (Oral PTH(1-34)) Anabolic Effect on Postmenopausal Women with Osteoporosis at High Risk for Fracture Selected for Plenary Poster Session Presentation at the ASBMR 2026 Annual Meeting

Entera Bio announced that post-hoc Phase 2 data for its oral anabolic tablet EB613 has been selected for a Plenary Poster Presentation at the ASBMR 2026 Annual Meeting. The analysis of 161 patients demonstrated markedly enhanced anabolic effects in postmenopausal women with osteoporosis at high risk for fracture, defined by a baseline T-score of ≤-2.5. Management is planning a single Phase 3 trial in approximately 750 patients to support a potential New Drug Application submission.

•2mo ago

Entera Bio Announces Pricing of Oversubscribed $275 Million Private Placement

Entera Bio priced an oversubscribed $275 million private placement at $2.04 per share, led by existing investor BVF Partners with participation from a syndicate of new healthcare-focused investors. The company intends to use the net proceeds to fully fund Phase 3 registrational studies for its lead asset EB613 and extend its cash runway into 2030. In connection with the financing, BVF secured the right to designate two directors to Entera's board, and Leerink Partners acted as lead placement agent.

•3mo ago

Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis

Entera Bio received positive FDA feedback on the Phase 3 registrational protocol for EB613, an oral anabolic tablet for postmenopausal osteoporosis. The agency accepted a plan for a single, randomized, double-blind trial in approximately 750 women with a primary endpoint of total hip BMD at 12 months, with topline data expected in the second half of 2028. Management highlighted that the agreement provides a clear regulatory path to submit a New Drug Application, aiming to offer an oral alternative to injectable therapies.

•4mo ago

Entera Reports Robust Preclinical Data for EB612 (Oral LA-PTH(1-34)) for Hypoparathyroidism and EB618 (Oral GLP-1/Glucagon) for Obesity at ENDO 2026

Entera Bio reported robust preclinical data at ENDO 2026 for EB612, an oral peptide for hypoparathyroidism, and EB618, an oral GLP-1/glucagon agonist for obesity. EB612 demonstrated sustained calcium increases and bioavailability across multiple animal models, supporting a planned IND submission in late 2026, while EB618 showed dose-proportional pharmacokinetics in primates. Both programs are co-developed with OPKO Health, and the company noted its EB613 osteoporosis candidate previously met primary and secondary endpoints in a 161-patient Phase 2 study.

•4mo ago

ENDO 2026 Oral Presentation Highlights Comparative Clinical Data for Entera’s Breakthrough Single Tablet EB613 (First-in-Class Oral PTH(1-34) Anabolic for Osteoporosis)

Entera Bio presented Late-Breaking Phase 1 data at ENDO 2026 showing its single-tablet oral EB613 achieves pharmacokinetic and pharmacodynamic profiles comparable to Eli Lilly’s injectable Forteo. The study of 15 healthy participants demonstrated that the single-tablet regimen matches the efficacy of the multi-tablet version while offering superior patient preference, with 14 of 15 participants preferring the single tablet and all preferring oral administration over daily injections. These results support Entera’s plan to advance EB613 into a pivotal Phase 3 study for osteoporosis, potentially establishing the first oral anabolic tablet for the condition.

•4mo ago

Entera’s EB613, First-in-Class Oral PTH(1-34) Anabolic for Osteoporosis - Single Tablet Data Selected for Late Breaking Oral Presentation at ENDO 2026 Annual Meeting; Additional Oral Peptide Pipeline Data Accepted for Presentation

Entera Bio’s lead candidate EB613, an oral tablet for osteoporosis, was selected for a Late Breaking Oral Presentation at the ENDO 2026 annual meeting. The presentation highlights new clinical data from a Phase 2 study of 161 postmenopausal women, which met both primary and secondary endpoints. This data supports the selection of a single EB613 tablet formulation for the company’s planned Phase 3 study. Additional abstracts for pipeline assets EB612 (hypoparathyroidism) and EB618 (obesity) were also accepted for presentation.

•5mo ago