#ENTx

StockTitan

@stocktitan.net

1 week ago

Entera Bio Submits Streamlined Phase 3 Protocol to Initiate Registrational Program for EB613 in Postmenopausal Women with Osteoporosis Phase 3 study designed with total hip BMD primary endpoint assessed at 12 months, rather than at 24 months EB613 single tablet final commercial formulation (Next-Gen EB613) replaces multi-tablet EB613 as Phase 3 candidate, following successful bridging study Topline data anticipated in the second

#ENTX Entera Bio Submits Streamlined Phase 3 Protocol to Initiate Registrational Program for EB613 in Postmenopausal Women with Osteoporosis

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StockTitan

@stocktitan.net

1 month ago

Entera Bio Announces Upcoming Q1 2026 Corporate Priorities and Pipeline Outlook Final EB613 Phase 3 Protocol Submission to FDA Planned for Q1 2026, Following December 19 th 2025 FDA Ruling Next-Generation EB613 Phase 1 Bridging Study Progressing with Results Expected During Q1 2026 Oral Hypoparathyroidism Tablet Program to Accelerate with Lead Long-Acting PTH Variants

#ENTX Entera Bio Announces Upcoming Q1 2026 Corporate Priorities and Pipeline Outlook

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StockTitan

@stocktitan.net

2 months ago

Entera Bio Congratulates the FNIH-ASBMR-SABRE Team on FDA’s Qualification of Total Hip BMD as Regulatory Endpoint: Huge Win for Osteoporosis Innovation Entera Bio (NASDAQ: ENTX) congratulated the FNIH‑ASBMR‑SABRE team after the FDA on Dec 23, 2025 broadly qualified total hip BMD as a validated surrogate regulatory endpoint for novel osteoporosis drugs in post‑menopausal women at risk of fracture. Entera highlighted that this qualification reinforces its July 2025 FDA alignment that a single Phase 3 using total hip BMD as the primary endpoint could support an NDA for EB613, and said the move may simplify and accelerate osteoporosis drug development while acknowledging remaining ethical and trial recruitment challenges.

#ENTX Entera Bio Congratulates the FNIH-ASBMR-SABRE Team on FDA’s Qualification of Total Hip BMD as Regulatory Endpoint: Huge Win for Osteoporosis Innovation

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StockTitan

@stocktitan.net

4 months ago

Entera Bio Announces Third Quarter 2025 Financial Results and Business Updates Entera Bio (NASDAQ: ENTX) reported Q3 2025 results and program updates on November 14, 2025. The FDA agreed that a single 24-month multinational Phase 3 of EB613 with change in total hip BMD as the primary endpoint and new/worsening vertebral fractures as key secondary would support an NDA.Phase 2 data showed rapid gains in trabecular and cortical bone indices and consistent BMD increases in women within 10 years of menopause. Cash and cash equivalents totaled $16.6 million (including $8.0M restricted), net loss was $3.2M for Q3, and cash runway is expected through the middle of Q3 2026. GLP-2 PK showed ~15‑hour half-life (18x improvement vs teduglutide); IND for oral OXM planned H1 2026.

#ENTX Entera Bio Announces Third Quarter 2025 Financial Results and Business Updates

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Small Cap Strategist

@smcapstrategist.bsky.social

4 months ago

Small-cap stocks with declining money flow, Mon Nov 10th - #ENTO #ACON #MLKN #ENTX #ACXP #RGR #GWH #FFWM - More: crystalequityresearch.com/leading-indi... - #smallcap

StockTitan

@stocktitan.net

4 months ago

Entera Bio Presents Positive New Clinical Data from EB613 Phase 2 Trial Demonstrating Significant Bone Density Improvements in Early Postmenopausal Women Consistency of BMD gains presented at NAMS 2025 demonstrate EB613’s efficacy in both young postmenopausal women and in women 10 years post-menopause Data further support EB613 potential as a first-in-class oral anabolic treatment option that could dramatically expand patient access to bone-building

#ENTX Entera Bio Presents Positive New Clinical Data from EB613 Phase 2 Trial Demonstrating Significant Bone Density Improvements in Early Postmenopausal Women

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StockTitan

@stocktitan.net

6 months ago

Entera Bio Reports Positive PK Data for First-in-Class Oral GLP-2 Tablet Treatment for Patients with Short Bowel Syndrome at the 2025 ESPEN Congress Entera Bio (NASDAQ: ENTX) presented positive pharmacokinetic data for its first-in-class oral GLP-2 tablet (OPK-8801003) at the 2025 ESPEN Congress. The treatment, developed in collaboration with OPKO Health, aims to revolutionize care for 30,000 Short Bowel Syndrome (SBS) patients currently dependent on daily injections.The preclinical data showed remarkable results: a 15-hour plasma half-life (18x longer than current treatment Gattex®), peak plasma concentrations of ~200 ng/ml, and sustained exposure for over 24 hours. The current GLP-2 market leader, Gattex®, generates $800 million in annual sales despite requiring daily subcutaneous injections.

#ENTX Entera Bio Reports Positive PK Data for First-in-Class Oral GLP-2 Tablet Treatment for Patients with Short Bowel Syndrome at the 2025 ESPEN Congress

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StockTitan

@stocktitan.net

6 months ago

4.4% Bone Density Improvement: Entera Bio's Oral Tablet Matches Injectable Osteoporosis Drugs in Phase 2 EB613 achieved significant bone density improvements in both trabecular (4.4%) and cortical bone after 6 months. Phase 3 trial planned following FDA concurrence. Next-gen tablet shows promising PK data.

#ENTX Entera Bio Presents Positive Effects of EB613 on Both Trabecular and Cortical Bone in Postmenopausal Women with Osteoporosis at ASBMR 2025

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StockTitan

@stocktitan.net

6 months ago

First-Ever Oral PTH Tablet Shows Positive BMD Results: Entera Bio's EB613 Phase 2 Data at ASBMR 2025 Entera Bio presents Phase 2 EB613 data showing BMD increases in both cortical and cancellous bone. Study of 161 postmenopausal women supports planned global Phase 3 trial following FDA alignment.

#ENTX Entera Bio to Unveil Clinical and Non-Clinical Data Across 3 Oral Peptide Programs at Upcoming September Conferences

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StockTitan

@stocktitan.net

7 months ago

Entera Bio Announces Second Quarter 2025 Financial Results and Business Updates Entera Bio (NASDAQ:ENTX) reported significant progress in Q2 2025, highlighted by FDA's agreement on using Bone Mineral Density (BMD) as the primary endpoint for EB613's Phase 3 program - a potential first oral anabolic osteoporosis treatment. The FDA also waived requirements for additional safety studies, streamlining the regulatory pathway.The company maintains a strong financial position with $18.9 million in cash, including $8.0 million restricted for OPKO collaboration, providing runway through mid-Q3 2026. Q2 resulted in a net loss of $2.7 million ($0.06 per share), compared to $2.1 million in Q2 2024.Pipeline developments include promising preclinical data for their obesity program with OPKO, featuring oral GLP-1/glucagon dual agonist showing comparable plasma levels to Wegovy™. Additionally, their next-generation EB613 is expected to enter Phase 1 trials in November 2025.

#ENTX Entera Bio Announces Second Quarter 2025 Financial Results and Business Updates

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StockTitan

@stocktitan.net

7 months ago

Entera Bio Receives FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study in Post-Menopausal Women with Osteoporosis Entera Bio (NASDAQ: ENTX) has received FDA agreement on using Bone Mineral Density (BMD) as the primary endpoint for its Phase 3 study of EB613, an oral treatment for post-menopausal osteoporosis. The FDA approved a 24-month phase 3 study design where total hip BMD will be the primary endpoint, with vertebral fractures as a secondary endpoint.This represents a significant shift from traditional osteoporosis drug trials that required fracture incidence as the primary endpoint. The development aims to create the first oral, once-daily anabolic tablet for osteoporosis treatment, addressing a market of over 200 million women globally who suffer from the condition.

#ENTX Entera Bio Receives FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study in Post-Menopausal Women with Osteoporosis

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StockTitan

@stocktitan.net

8 months ago

Revolutionary Oral Alternative to Injectable GATTEX: New Short Bowel Syndrome Treatment Data Coming to ESPEN First-in-class oral GLP-2 tablet could replace daily injections for Short Bowel Syndrome treatment. See breakthrough data presentation details at ESPEN Congress.

#ENTX OPKO Health and Entera Bio Announce Abstract on PK/PD of Oral GLP-2 Tablet for the Treatment of Short Bowel Syndrome Selected for 2025 ESPEN Congress

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StockTitan

@stocktitan.net

8 months ago

First-Ever Oral Bone Formation Drug Could Transform Osteoporosis Treatment for 200M Women New clinical data reveals EB613's dual action on bone formation and density. First oral alternative to injectable osteoporosis treatments shows promise. See full results.

#ENTX Entera Bio Data for EB613 Effects on Trabecular and Cortical Bone in Post-Menopausal Women with Osteoporosis Selected for Oral Presentation at ASBMR 2025 Annual Meeting

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C.W. David Chang, MD

@drcwdavidchang.bsky.social

9 months ago

Where's the Leak? YouTube video by David Chang

Where's the Leak? Sometimes the location of a #CSF leak isn't always obvious. #ENTSurgery #ENTx #sinus #ResidENT

youtu.be/Wj9LMJzmNt0?... via
@YouTube

StockTitan

@stocktitan.net

10 months ago

Entera Bio Announces First Quarter 2025 Financial Results and Business Updates Entera Bio (NASDAQ: ENTX) reported Q1 2025 financial results and business updates. The company's cash position stands at $20.6 million, expected to fund operations through Q3 2026. Key developments include: 1) Progress on EB613, their oral PTH tablet for osteoporosis, with positive 3D-Shaper analysis data selected for presentation at WCO Congress. 2) Partnership with OPKO Health to co-develop Oral OPK-88006, a dual GLP1/Glucagon tablet for metabolic diseases, with Entera retaining 40% stake. 3) Q1 2025 financial results showed R&D expenses of $1.1M (up from $0.7M in Q1 2024) and G&A expenses of $1.4M (up from $1.3M). Net loss was $2.6M or $0.06 per share. 4) Key appointments include Leslie Gautam as Chief Business Officer and Cherin Smith as Head of Clinical Operations. The company plans to initiate Phase 1 study for Next Gen EB613 in H2 2025.

#ENTX Entera Bio Announces First Quarter 2025 Financial Results and Business Updates

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サードニュース@相互フォロー100%

@new3rd.bsky.social

10 months ago

月への新たな一歩！ispaceとentX、豪州政府からの助成金を受けて革新技術実証へ ispaceとentXが南オーストラリア州政府から助成金を受け、月面越夜対応の技術実証に挑戦。未来の月探査を見据えた取り組みが新たなステージへ進展します。

月への新たな一歩！ispaceとentX、豪州政府からの助成金を受けて革新技術実証へ #ispace #月面探査 #entX

ispaceとentXが南オーストラリア州政府から助成金を受け、月面越夜対応の技術実証に挑戦。未来の月探査を見据えた取り組みが新たなステージへ進展します。

StockTitan

@stocktitan.net

11 months ago

Entera Bio Announces Full Year 2024 Financial Results and Provides Business Updates Entera Bio (NASDAQ: ENTX) reported its financial results for 2024, marking a transformational year in developing oral peptide therapies. The company's flagship product, EB613, the first oral PTH(1-34) tablet for osteoporosis, made significant progress with published Phase 2 trial results in JBMR.Key developments include successful results in their GLP-1/Glucagon program with OPKO Health, showing significant systemic exposure and glucose reduction. The company also advanced their GLP-2 peptide tablets program for Short Bowel Syndrome, demonstrating 10-fold higher plasma levels compared to existing treatments.Financial highlights: Cash position of $21 million as of March 2025, sufficient until Q3 2026. R&D expenses remained stable at $4.5 million, while G&A expenses increased to $5.1 million. Net loss for 2024 was $9.5 million ($0.25 per share) compared to $8.9 million ($0.31 per share) in 2023.

#ENTX Entera Bio Announces Full Year 2024 Financial Results and Provides Business Updates

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StockTitan

@stocktitan.net

11 months ago

OPKO Health and Entera Bio Enter into Collaboration Agreement to Advance Oral GLP-1/Glucagon Tablet Candidate into the Clinic to Treat Obesity and Metabolic Disorders OPKO Health, Inc. (NASDAQ: OPK) and Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, entered into a collaboration and license agreement to advance into the clinic the first oral

#ENTX OPKO Health and Entera Bio Enter into Collaboration Agreement to Advance Oral GLP-1/Glucagon Tablet Candidate into the Clinic to Treat Obesity and Metabolic Disorders

www.stocktitan.net/news/ENTX/opko-health-an...