Entera Bio Receives FDA Feedback on EB613
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 22 2026
0mins
Entera Bio announced that it has received feedback from the FDA on its Phase 3 registrational protocol for EB613, the first oral anabolic tablet in development for the treatment of osteoporosis. The FDA feedback is in response to a Clinical Amendment submitted by Entera to its investigational new drug, or IND, application, as announced in March. The FDA accepted Entera's plan to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of percent change from baseline in total hip BMD at Month 12 to support a potential new drug application submission for EB613 for the treatment of women with post-menopausal osteoporosis. The proposed NDA package will also include Entera's scientific bridge analysis with Forteo under the 505 pathway, and a transiliac crest bone biopsy sub-study in a subset of patients. The FDA also agreed with Entera's proposal to continue following the randomized patients out to 24 months in an open-label extension study under a separate protocol. Entera will plan to submit data through up to 18 months as part of the 120-day safety update to its NDA. Additionally, Entera will submit the complete 2-year data upon completion of the open-label extension study to characterize further the durability of the treatment effect, safety, and sequence data for EB613 followed by a standard anti-resorptive therapy for 12 months. The registrational study is powered to demonstrate EB613's clinical effectiveness with projected increases in total hip BMD that are comparable to reported outcomes for Forteo at 12 months, changes associated with a 60% to 80% relative reduction in vertebral fracture risk. The company plans to initiate the registrational Phase 3 study in late 2026, with topline results anticipated in the second half of 2028.
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About ENTX
Entera Bio Ltd is an Israel-based clinical-stage biopharmaceutical company focused on the development and commercialization of orally delivered large molecule therapeutics for use in areas with unmet medical need and where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company developed a platform that enables the oral delivery of injectable proteins and large molecules. Entera Bio candidates are EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism. Both EB613 and EB612 are oral formulations of human parathyroid hormone (1-34), or Parathormon (PTH). The products are administered via injection.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Entera Bio Receives Positive FDA Feedback for EB613 Phase 3 Trial Approval
- Regulatory Breakthrough: Entera Bio announced that the FDA has provided positive feedback on its EB613 registrational Phase 3 trial protocol, marking a significant step in the development of oral osteoporosis treatments, with the potential to become the first oral anabolic therapy in the market.
- Clinical Design Approval: The FDA accepted Entera Bio's proposed design for a randomized, double-blind, placebo-controlled Phase 3 study involving approximately 750 postmenopausal women, with total hip bone mineral density at 12 months as the primary endpoint, laying the groundwork for a future New Drug Application.
- Significant Market Potential: With around 200 million women affected by osteoporosis globally and over 2 million fractures occurring annually in the U.S., Entera Bio's EB613 aims to address the low adoption rates of existing injectable therapies, potentially expanding the patient base significantly.
- Diversified Product Pipeline: In addition to EB613, Entera Bio is advancing multiple oral peptide drugs, including EB612 and EB618, showcasing its robust platform capabilities in oral peptide technology, which enhances the company's competitive position in the market.
See More
Entera Bio's Bone Density Treatment Trial Progress
- FDA Support for New Trial: The U.S. FDA has approved Entera Bio's EB613 for a single large late-stage clinical trial, aiming to enroll approximately 750 postmenopausal women, which is a significant advancement in the treatment of osteoporosis and supports the company's path toward FDA approval.
- Accelerated Timeline: Entera expects to begin the trial in late 2026 and report top-line results in the second half of 2028, about a year earlier than previously planned, which will expedite the product's market entry and enhance its competitive position.
- Significant Early Study Results: The company's earlier mid-stage study involving 161 postmenopausal women demonstrated meaningful increases in bone density at the spine and hip, indicating the potential of EB613 in osteoporosis treatment and likely attracting more patients to its use.
- Market Sentiment Shift: ENTX shares surged 52% following FDA feedback, with retail investor sentiment jumping from 'bullish' to 'extremely bullish', while analysts rated the stock a 'Buy' with a price target of $9, suggesting a potential upside of about 643%, reflecting strong market confidence in the drug.
See More
Entera Bio Initiates Phase 3 Trial for EB613 in Osteoporosis
- Positive FDA Feedback: Entera Bio has received positive feedback from the FDA regarding the Phase 3 registration protocol for EB613, planning a randomized double-blind trial in 750 postmenopausal women to assess changes in hip bone mineral density at 12 months, supporting its New Drug Application (NDA).
- Clinical Trial Design: The Phase 3 trial is expected to initiate in late 2026, with topline data anticipated in the second half of 2028, and EB613's clinical effectiveness is projected to be comparable to Forteo®, potentially achieving a 60% to 80% relative reduction in vertebral fracture risk.
- Safety and Durability Study: Entera plans to submit 12-month data in its NDA and follow patients for 24 months in an open-label extension study to further evaluate EB613's safety and durability of treatment effect, enhancing its competitive position in the market.
- Significant Market Potential: With over 2 million fractures occurring annually in the U.S., the development of EB613 as the first oral anabolic treatment aims to provide a more convenient therapeutic option for postmenopausal women, addressing the growing market demand.
See More
Entera Bio Reports Preclinical Data for EB612 and EB618
- EB612 Clinical Data: Entera Bio's EB612 demonstrated robust bioavailability and sustained calcium increases across three preclinical models, with an IND application expected by late 2026, marking a significant advancement in treating hypoparathyroidism.
- Good Tolerability: In non-human primate models, a single oral dose of EB612 significantly raised serum calcium levels for three days without safety concerns, laying a solid foundation for its future clinical applications.
- EB618 Efficacy: As the first dual GLP-1/glucagon receptor agonist, EB618 exhibited dose-proportional pharmacokinetics in non-human primates and showed good tolerability even at doses exceeding the anticipated clinical range, supporting its potential in obesity and metabolic disorder treatments.
- Collaborative Development Strategy: Entera's partnership with OPKO Health has expanded, with both companies advancing EB612 on a 50/50 basis, showcasing Entera's strong R&D capabilities and market prospects in the oral peptide drug sector.
See More
Entera Bio Hosts KOL Roundtable on EB613 for Osteoporosis
- Significant Treatment Gap: Approximately two million osteoporotic fractures occur annually in the U.S., and while 92% of gynecologists would prescribe anabolic therapy if an oral option were available, only 12% currently use injectable anabolic agents, highlighting a substantial treatment gap.
- Clinical Potential of EB613: As the first oral anabolic agent, EB613 stimulates bone formation while suppressing bone breakdown, with six-month bone density increments comparable to injectable PTH, potentially transforming the current treatment paradigm.
- Clinical Trial Plans: Entera Bio intends to advance EB613 into Phase 3 trials imminently, designed to evaluate its efficacy both as a monotherapy and in combination with anti-resorptive agents, further validating its application in osteoporosis treatment.
- Increased Patient Acceptance: The oral formulation of EB613 is expected to reduce patient resistance to injectable therapies, significantly enhancing treatment adherence and thereby improving bone health and quality of life.
See More
Entera Bio Secures $10 Million in Private Placement Financing
- Financing Size: Entera Bio successfully issued 7,827,789 units at a price of $1.2775 per unit, raising approximately $10 million, reflecting strong market confidence in its biotechnology developments.
- Potential Gains: If all warrants issued are exercised for cash, Entera could receive an additional $14.5 million, leading to total potential proceeds of approximately $24.5 million, thereby enhancing its financial strength to support R&D.
- Use of Funds: The net proceeds from this financing will be used to initiate the Phase 3 registrational study of EB613 targeting osteoporosis in postmenopausal women, as well as for working capital and general corporate purposes, ensuring the company's ongoing development.
- Legal Support: Greenberg Traurig advised Entera on this transaction, led by Drew M. Altman, showcasing the firm's expertise and influence in the biotechnology sector.
See More
Entera Bio Receives Positive FDA Feedback for EB613 Phase 3 Trial Approval
- Regulatory Breakthrough: Entera Bio announced that the FDA has provided positive feedback on its EB613 registrational Phase 3 trial protocol, marking a significant step in the development of oral osteoporosis treatments, with the potential to become the first oral anabolic therapy in the market.
- Clinical Design Approval: The FDA accepted Entera Bio's proposed design for a randomized, double-blind, placebo-controlled Phase 3 study involving approximately 750 postmenopausal women, with total hip bone mineral density at 12 months as the primary endpoint, laying the groundwork for a future New Drug Application.
- Significant Market Potential: With around 200 million women affected by osteoporosis globally and over 2 million fractures occurring annually in the U.S., Entera Bio's EB613 aims to address the low adoption rates of existing injectable therapies, potentially expanding the patient base significantly.
- Diversified Product Pipeline: In addition to EB613, Entera Bio is advancing multiple oral peptide drugs, including EB612 and EB618, showcasing its robust platform capabilities in oral peptide technology, which enhances the company's competitive position in the market.
See More
Entera Bio's Bone Density Treatment Trial Progress
- FDA Support for New Trial: The U.S. FDA has approved Entera Bio's EB613 for a single large late-stage clinical trial, aiming to enroll approximately 750 postmenopausal women, which is a significant advancement in the treatment of osteoporosis and supports the company's path toward FDA approval.
- Accelerated Timeline: Entera expects to begin the trial in late 2026 and report top-line results in the second half of 2028, about a year earlier than previously planned, which will expedite the product's market entry and enhance its competitive position.
- Significant Early Study Results: The company's earlier mid-stage study involving 161 postmenopausal women demonstrated meaningful increases in bone density at the spine and hip, indicating the potential of EB613 in osteoporosis treatment and likely attracting more patients to its use.
- Market Sentiment Shift: ENTX shares surged 52% following FDA feedback, with retail investor sentiment jumping from 'bullish' to 'extremely bullish', while analysts rated the stock a 'Buy' with a price target of $9, suggesting a potential upside of about 643%, reflecting strong market confidence in the drug.
See More
Entera Bio Initiates Phase 3 Trial for EB613 in Osteoporosis
- Positive FDA Feedback: Entera Bio has received positive feedback from the FDA regarding the Phase 3 registration protocol for EB613, planning a randomized double-blind trial in 750 postmenopausal women to assess changes in hip bone mineral density at 12 months, supporting its New Drug Application (NDA).
- Clinical Trial Design: The Phase 3 trial is expected to initiate in late 2026, with topline data anticipated in the second half of 2028, and EB613's clinical effectiveness is projected to be comparable to Forteo®, potentially achieving a 60% to 80% relative reduction in vertebral fracture risk.
- Safety and Durability Study: Entera plans to submit 12-month data in its NDA and follow patients for 24 months in an open-label extension study to further evaluate EB613's safety and durability of treatment effect, enhancing its competitive position in the market.
- Significant Market Potential: With over 2 million fractures occurring annually in the U.S., the development of EB613 as the first oral anabolic treatment aims to provide a more convenient therapeutic option for postmenopausal women, addressing the growing market demand.
See More
Entera Bio Reports Preclinical Data for EB612 and EB618
- EB612 Clinical Data: Entera Bio's EB612 demonstrated robust bioavailability and sustained calcium increases across three preclinical models, with an IND application expected by late 2026, marking a significant advancement in treating hypoparathyroidism.
- Good Tolerability: In non-human primate models, a single oral dose of EB612 significantly raised serum calcium levels for three days without safety concerns, laying a solid foundation for its future clinical applications.
- EB618 Efficacy: As the first dual GLP-1/glucagon receptor agonist, EB618 exhibited dose-proportional pharmacokinetics in non-human primates and showed good tolerability even at doses exceeding the anticipated clinical range, supporting its potential in obesity and metabolic disorder treatments.
- Collaborative Development Strategy: Entera's partnership with OPKO Health has expanded, with both companies advancing EB612 on a 50/50 basis, showcasing Entera's strong R&D capabilities and market prospects in the oral peptide drug sector.
See More
Entera Bio Hosts KOL Roundtable on EB613 for Osteoporosis
- Significant Treatment Gap: Approximately two million osteoporotic fractures occur annually in the U.S., and while 92% of gynecologists would prescribe anabolic therapy if an oral option were available, only 12% currently use injectable anabolic agents, highlighting a substantial treatment gap.
- Clinical Potential of EB613: As the first oral anabolic agent, EB613 stimulates bone formation while suppressing bone breakdown, with six-month bone density increments comparable to injectable PTH, potentially transforming the current treatment paradigm.
- Clinical Trial Plans: Entera Bio intends to advance EB613 into Phase 3 trials imminently, designed to evaluate its efficacy both as a monotherapy and in combination with anti-resorptive agents, further validating its application in osteoporosis treatment.
- Increased Patient Acceptance: The oral formulation of EB613 is expected to reduce patient resistance to injectable therapies, significantly enhancing treatment adherence and thereby improving bone health and quality of life.
See More
Entera Bio Secures $10 Million in Private Placement Financing
- Financing Size: Entera Bio successfully issued 7,827,789 units at a price of $1.2775 per unit, raising approximately $10 million, reflecting strong market confidence in its biotechnology developments.
- Potential Gains: If all warrants issued are exercised for cash, Entera could receive an additional $14.5 million, leading to total potential proceeds of approximately $24.5 million, thereby enhancing its financial strength to support R&D.
- Use of Funds: The net proceeds from this financing will be used to initiate the Phase 3 registrational study of EB613 targeting osteoporosis in postmenopausal women, as well as for working capital and general corporate purposes, ensuring the company's ongoing development.
- Legal Support: Greenberg Traurig advised Entera on this transaction, led by Drew M. Altman, showcasing the firm's expertise and influence in the biotechnology sector.
See More
