Entera Bio Submits Clinical Amendment for EB613
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 04 2026
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Should l Buy ENTX?
Source: Newsfilter
- Optimized Clinical Design: Entera Bio's submission of a clinical amendment to the FDA streamlines the Phase 3 trial protocol for EB613, with the primary endpoint assessed at 12 months instead of 24, thereby accelerating the approval process and enhancing patient recruitment efficiency.
- New Drug Candidate: The final single-tablet formulation of EB613 replaces the multi-tablet version, with plans to initiate the Phase 3 study in late 2026, aiming to improve patient adherence through a simplified dosing regimen, which is expected to drive market acceptance.
- Data Release Accelerated: The company anticipates topline data from the Phase 3 trial in the second half of 2028, approximately one year earlier than previously expected, which will help Entera secure a competitive advantage in the rapidly evolving osteoporosis treatment market.
- Strategic Expansion Plans: Entera also plans a 12-month open-label extension study to run in parallel with the NDA review, aimed at further validating the long-term efficacy and safety of EB613, thereby enhancing market confidence and facilitating commercialization efforts.
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Analyst Views on ENTX
Wall Street analysts forecast ENTX stock price to rise
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1 Buy
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Moderate Buy
Current: 1.030
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Current: 1.030
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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 Reports 2025 Financial Results and Key Developments
- EB613 Clinical Progress: In March 2026, Entera submitted a streamlined Phase 3 protocol for EB613 to the FDA, planning a randomized double-blind trial with 750 postmenopausal women, primarily assessing changes in hip bone mineral density over 12 months, which could accelerate the approval process and yield topline results by the second half of 2028.
- Key FDA Feedback: In July 2025, the FDA agreed to evaluate changes in hip bone mineral density as the primary endpoint for EB613, marking Entera as the first company to achieve such independent alignment, thereby enhancing the likelihood of a successful NDA submission.
- EB612 Collaboration Expansion: Entera expanded its collaboration with OPKO in February 2026 to co-develop an oral long-acting PTH replacement therapy, with both parties holding equal stakes and planning to file an IND application by late 2026, thus accelerating the clinical pathway for this program.
- Financial Performance: As of December 31, 2025, Entera reported cash and cash equivalents of $14.9 million, a net loss of $11.4 million, and R&D expenses of $6.0 million, reflecting the company's capital efficiency in advancing EB613 and other pipeline projects.
See More
Entera Bio Reports FY 2025 Financial Results
- Earnings Highlights: Entera Bio's FY 2025 GAAP EPS stands at -$0.25, beating expectations by $0.03, indicating a slight improvement in financial performance despite remaining in a loss position.
- Revenue Performance: The company reported revenue of $0.04M, a significant decline of 77.8% year-over-year, reflecting weak market demand and sales challenges that could impact future liquidity and investor confidence.
- Cash Position: As of December 31, 2025, Entera Bio had cash and cash equivalents of $14.9 million, including $7.8 million in restricted cash earmarked for the OPKO collaboration, demonstrating cautious financial management amid operational challenges.
- Operating Cash Flow: The net cash used in operating activities for FY 2025 was $7.4 million, indicating the company's reliance on external financing to sustain daily operations, which may pose risks to its long-term viability.
See More
Entera Bio Submits Clinical Amendment for EB613
- Optimized Clinical Design: Entera Bio's submission of a clinical amendment to the FDA streamlines the Phase 3 trial protocol for EB613, with the primary endpoint assessed at 12 months instead of 24, thereby accelerating the approval process and enhancing patient recruitment efficiency.
- New Drug Candidate: The final single-tablet formulation of EB613 replaces the multi-tablet version, with plans to initiate the Phase 3 study in late 2026, aiming to improve patient adherence through a simplified dosing regimen, which is expected to drive market acceptance.
- Data Release Accelerated: The company anticipates topline data from the Phase 3 trial in the second half of 2028, approximately one year earlier than previously expected, which will help Entera secure a competitive advantage in the rapidly evolving osteoporosis treatment market.
- Strategic Expansion Plans: Entera also plans a 12-month open-label extension study to run in parallel with the NDA review, aimed at further validating the long-term efficacy and safety of EB613, thereby enhancing market confidence and facilitating commercialization efforts.
See More
Entera Bio Shares Surge 15.71% After SEC Filing by Director
- Director Share Acquisition: Entera Bio's Director Steven D. Rubin purchased 5,000 ordinary shares at $1.49 each on February 12, totaling $7,450, increasing his direct holdings to 15,000 shares, indicating confidence in the company's future prospects.
- Stock Price Fluctuation: The stock surged 15.71% in after-hours trading to $1.62, following a 1.41% decline to $1.40 during regular trading, reflecting a positive market reaction to the SEC filing.
- Market Capitalization and Technical Indicators: Entera Bio has a market cap of $64.20 million, with a 52-week high of $3.22 and a low of $1, currently positioned about 18% above its 52-week low, indicating low volatility within its annual range.
- Analyst Ratings and Outlook: HC Wainwright & Co. reiterated a
See More
Entera Bio Board Members Increase Shareholdings
- Board Members Buy Shares: Entera Bio's Chairman Geno J. Germano purchased 20,000 shares at $1.49 each, while directors Steven D. Rubin, Haya Taitel, and Sean Ellis bought 10,000, 7,500, and 18,000 shares respectively at prices ranging from $1.20 to $1.48, indicating strong confidence in the company's future.
- Positive Market Reaction: Following the announcement of board member purchases, Entera Bio's stock surged 13% on Wednesday, reflecting optimistic market sentiment despite a 31% decline in stock price over the past year.
- CEO's Prior Purchases: This buying activity follows Entera's CEO Miranda Toledano's share purchases in December, demonstrating ongoing trust in the company's strategic direction, which may bolster investor confidence.
- Optimistic Market Sentiment: On Stocktwits, retail sentiment around ENTX stock remained in the 'bullish' territory with extremely high message volume, indicating strong expectations for the company's future, as users expressed optimism about the share purchases not being a waste of money.
See More
Entera Bio Plans Final EB613 Protocol Submission to FDA in Q1 2026
- FDA Submission Plan: Entera Bio plans to submit the final Phase 3 protocol for EB613 to the FDA in Q1 2026, following the FDA's broad qualification of bone mineral density as a regulatory endpoint for anti-osteoporosis drugs on December 19, 2025, which is expected to enhance the company's market position in osteoporosis.
- Clinical Study Progress: The Phase 1 bridging study for Next-Gen EB613, initiated in November 2025, is progressing on schedule with results expected by the end of Q1 2026, providing significant commercial and strategic advantages for the company.
- Accelerated Treatment Program: Entera plans to accelerate its hypoparathyroidism treatment program in 2026 based on robust preclinical PK/PD data for a proprietary long-acting PTH analog announced in late December 2025, aiming to meet the urgent market demand for new therapies.
- Strategic Partnership Discussions: The company is actively engaging in strategic partnership discussions to optimize the development and commercialization pathway for its first-in-class oral peptide programs, indicating a strong commitment to investment and innovation in areas of unmet medical needs.
See More
Entera Bio Reports 2025 Financial Results and Key Developments
- EB613 Clinical Progress: In March 2026, Entera submitted a streamlined Phase 3 protocol for EB613 to the FDA, planning a randomized double-blind trial with 750 postmenopausal women, primarily assessing changes in hip bone mineral density over 12 months, which could accelerate the approval process and yield topline results by the second half of 2028.
- Key FDA Feedback: In July 2025, the FDA agreed to evaluate changes in hip bone mineral density as the primary endpoint for EB613, marking Entera as the first company to achieve such independent alignment, thereby enhancing the likelihood of a successful NDA submission.
- EB612 Collaboration Expansion: Entera expanded its collaboration with OPKO in February 2026 to co-develop an oral long-acting PTH replacement therapy, with both parties holding equal stakes and planning to file an IND application by late 2026, thus accelerating the clinical pathway for this program.
- Financial Performance: As of December 31, 2025, Entera reported cash and cash equivalents of $14.9 million, a net loss of $11.4 million, and R&D expenses of $6.0 million, reflecting the company's capital efficiency in advancing EB613 and other pipeline projects.
See More
Entera Bio Reports FY 2025 Financial Results
- Earnings Highlights: Entera Bio's FY 2025 GAAP EPS stands at -$0.25, beating expectations by $0.03, indicating a slight improvement in financial performance despite remaining in a loss position.
- Revenue Performance: The company reported revenue of $0.04M, a significant decline of 77.8% year-over-year, reflecting weak market demand and sales challenges that could impact future liquidity and investor confidence.
- Cash Position: As of December 31, 2025, Entera Bio had cash and cash equivalents of $14.9 million, including $7.8 million in restricted cash earmarked for the OPKO collaboration, demonstrating cautious financial management amid operational challenges.
- Operating Cash Flow: The net cash used in operating activities for FY 2025 was $7.4 million, indicating the company's reliance on external financing to sustain daily operations, which may pose risks to its long-term viability.
See More
Entera Bio Submits Clinical Amendment for EB613
- Optimized Clinical Design: Entera Bio's submission of a clinical amendment to the FDA streamlines the Phase 3 trial protocol for EB613, with the primary endpoint assessed at 12 months instead of 24, thereby accelerating the approval process and enhancing patient recruitment efficiency.
- New Drug Candidate: The final single-tablet formulation of EB613 replaces the multi-tablet version, with plans to initiate the Phase 3 study in late 2026, aiming to improve patient adherence through a simplified dosing regimen, which is expected to drive market acceptance.
- Data Release Accelerated: The company anticipates topline data from the Phase 3 trial in the second half of 2028, approximately one year earlier than previously expected, which will help Entera secure a competitive advantage in the rapidly evolving osteoporosis treatment market.
- Strategic Expansion Plans: Entera also plans a 12-month open-label extension study to run in parallel with the NDA review, aimed at further validating the long-term efficacy and safety of EB613, thereby enhancing market confidence and facilitating commercialization efforts.
See More
Entera Bio Shares Surge 15.71% After SEC Filing by Director
- Director Share Acquisition: Entera Bio's Director Steven D. Rubin purchased 5,000 ordinary shares at $1.49 each on February 12, totaling $7,450, increasing his direct holdings to 15,000 shares, indicating confidence in the company's future prospects.
- Stock Price Fluctuation: The stock surged 15.71% in after-hours trading to $1.62, following a 1.41% decline to $1.40 during regular trading, reflecting a positive market reaction to the SEC filing.
- Market Capitalization and Technical Indicators: Entera Bio has a market cap of $64.20 million, with a 52-week high of $3.22 and a low of $1, currently positioned about 18% above its 52-week low, indicating low volatility within its annual range.
- Analyst Ratings and Outlook: HC Wainwright & Co. reiterated a
See More
Entera Bio Board Members Increase Shareholdings
- Board Members Buy Shares: Entera Bio's Chairman Geno J. Germano purchased 20,000 shares at $1.49 each, while directors Steven D. Rubin, Haya Taitel, and Sean Ellis bought 10,000, 7,500, and 18,000 shares respectively at prices ranging from $1.20 to $1.48, indicating strong confidence in the company's future.
- Positive Market Reaction: Following the announcement of board member purchases, Entera Bio's stock surged 13% on Wednesday, reflecting optimistic market sentiment despite a 31% decline in stock price over the past year.
- CEO's Prior Purchases: This buying activity follows Entera's CEO Miranda Toledano's share purchases in December, demonstrating ongoing trust in the company's strategic direction, which may bolster investor confidence.
- Optimistic Market Sentiment: On Stocktwits, retail sentiment around ENTX stock remained in the 'bullish' territory with extremely high message volume, indicating strong expectations for the company's future, as users expressed optimism about the share purchases not being a waste of money.
See More
Entera Bio Plans Final EB613 Protocol Submission to FDA in Q1 2026
- FDA Submission Plan: Entera Bio plans to submit the final Phase 3 protocol for EB613 to the FDA in Q1 2026, following the FDA's broad qualification of bone mineral density as a regulatory endpoint for anti-osteoporosis drugs on December 19, 2025, which is expected to enhance the company's market position in osteoporosis.
- Clinical Study Progress: The Phase 1 bridging study for Next-Gen EB613, initiated in November 2025, is progressing on schedule with results expected by the end of Q1 2026, providing significant commercial and strategic advantages for the company.
- Accelerated Treatment Program: Entera plans to accelerate its hypoparathyroidism treatment program in 2026 based on robust preclinical PK/PD data for a proprietary long-acting PTH analog announced in late December 2025, aiming to meet the urgent market demand for new therapies.
- Strategic Partnership Discussions: The company is actively engaging in strategic partnership discussions to optimize the development and commercialization pathway for its first-in-class oral peptide programs, indicating a strong commitment to investment and innovation in areas of unmet medical needs.
See More
