Entera Bio Reports Q3 2024 Financial Results and Provides Business Updates
Financial Results and Business Updates: Entera Bio Ltd. reported a net loss of $3 million for Q3 2024, with cash reserves of $6.9 million expected to last until Q3 2025. The company is advancing its oral peptide therapies, particularly EB613 for osteoporosis, and anticipates a significant FDA ruling in January 2025.
Clinical Developments: Entera is developing several innovative oral treatments, including the first oral PTH(1-34) tablet for osteoporosis, an oral GLP-1/glucagon dual agonist for obesity, and a GLP-2 tablet for short bowel syndrome, aiming to address significant unmet medical needs in women's health and metabolic disorders.
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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.
China SXT Pharmaceuticals (SXTC) Closes $10 Million Offering, Stock Rises 17.4%
- Successful Financing: China SXT Pharmaceuticals, Inc. announced the closing of a registered direct offering valued at approximately $10 million, selling 66,666,666 Class A ordinary shares at $0.15 each to a single investor, thereby strengthening its balance sheet and boosting investor confidence.
- Financial Guidance: TG Therapeutics reported preliminary U.S. net product revenue for its multiple sclerosis therapy BRIUMVI for Q4 and full-year 2025, with shares rising 6.99% to $29.82, showcasing the company's growth potential.
- FDA Review Progress: Argenx SE's supplemental Biologics License Application for VYVGART, aimed at treating adults with acetylcholine receptor antibody seronegative generalized myasthenia gravis, has been accepted for priority review by the FDA, with a target action date of May 10, 2026, indicating potential for expanded indications.
- Market Trends: Cosmos Health Inc. saw its stock rise 6.09% to $0.4961 despite no specific news, reflecting speculative interest and momentum trading in the micro-cap healthcare sector.
Entera Receives FDA Qualification of Total Hip BMD as a Key Endpoint for Osteoporosis Drug Development
- FDA Qualification: Entera Bio has received broad FDA qualification for total hip bone mineral density (BMD) as a validated regulatory endpoint, which will simplify the pathway for its NDA submission for EB613, potentially accelerating drug development timelines.
- Market Demand: With over 200 million women globally estimated to have osteoporosis and largely undertreated, this regulatory reform by the FDA presents Entera with a significant opportunity to address this unmet medical need, enhancing its competitive position in the market.
- Clinical Trial Innovation: EB613, as the first oral once-daily anabolic treatment, has successfully met all biomarker and BMD endpoints in a Phase 2 trial involving 161 patients, demonstrating its potential to lower fracture risk and possibly transform the treatment landscape for osteoporosis.
- Strategic Vision: Entera's CEO emphasized the company's commitment to improving the quality of life for osteoporosis patients through innovative therapies, with FDA support likely facilitating broader market access by 2025, furthering the democratization of osteoporosis treatment globally.
Entera Bio Reports Financial Results and Business Developments for Q3 2025
FDA Agreement on EB613: The FDA has approved Entera Bio's proposal for a Phase 3 study of EB613, focusing on bone mineral density (BMD) as the primary endpoint, which aims to support a New Drug Application for the first oral treatment for osteoporosis in post-menopausal women.
Phase 2 Data Highlights: Recent presentations at major medical conferences showcased EB613's significant efficacy in increasing both trabecular and cortical bone indices in younger post-menopausal women, indicating rapid bone strengthening comparable to existing injectable treatments.
Next-Generation EB613 and Other Programs: Entera is on track to initiate a Phase 1 trial for a next-generation version of EB613 in late 2025, while also advancing oral therapies for short bowel syndrome and obesity in collaboration with OPKO Health.
Financial Overview: For the quarter ending September 30, 2025, Entera reported a net loss of $3.2 million, with cash reserves expected to support operations through mid-2026, reflecting ongoing investments in research and development for its innovative oral peptide therapies.
Entera Bio Unveils Promising New Clinical Results from EB613 Phase 2 Trial Showing Notable Bone Density Gains in Early Postmenopausal Women
EB613 Efficacy: New clinical data presented at NAMS 2025 shows that EB613, an oral anabolic treatment, significantly increases bone mineral density (BMD) in both early postmenopausal women and those more than 10 years post-menopause, addressing a critical need in osteoporosis care.
Phase 3 Study Plans: Entera Bio plans to initiate a global Phase 3 study for EB613 following FDA concurrence in July 2025, aiming to provide a first-in-class oral therapy for postmenopausal women at high risk for fractures.
Patient Access and Compliance: The oral formulation of EB613 could enhance patient access to anabolic therapy, which is often underutilized due to the challenges associated with injectable treatments, potentially transforming osteoporosis management.
Company Overview: Entera Bio is focused on developing oral peptide therapies for unmet medical needs, with EB613 being its lead candidate for osteoporosis, alongside other innovative oral treatments for various conditions.
Entera Bio Reveals Encouraging Pharmacokinetic Data for Its First Oral GLP-2 Treatment
Encouraging Pharmacokinetic Data: Entera Bio Ltd. reported promising pharmacokinetic results for its oral GLP-2 analog therapy, OPK-8801003, aimed at treating short bowel syndrome (SBS), which could offer a more convenient alternative to the current injectable treatment, Gattex.
Market Potential and Investor Sentiment: The positive findings may enhance investor confidence in Entera's pipeline and the N-Tab oral peptide platform, as the therapy addresses a significant unmet need in a rare disease market valued at nearly $800 million annually, despite Entera's stock facing recent declines.
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.
China SXT Pharmaceuticals (SXTC) Closes $10 Million Offering, Stock Rises 17.4%
- Successful Financing: China SXT Pharmaceuticals, Inc. announced the closing of a registered direct offering valued at approximately $10 million, selling 66,666,666 Class A ordinary shares at $0.15 each to a single investor, thereby strengthening its balance sheet and boosting investor confidence.
- Financial Guidance: TG Therapeutics reported preliminary U.S. net product revenue for its multiple sclerosis therapy BRIUMVI for Q4 and full-year 2025, with shares rising 6.99% to $29.82, showcasing the company's growth potential.
- FDA Review Progress: Argenx SE's supplemental Biologics License Application for VYVGART, aimed at treating adults with acetylcholine receptor antibody seronegative generalized myasthenia gravis, has been accepted for priority review by the FDA, with a target action date of May 10, 2026, indicating potential for expanded indications.
- Market Trends: Cosmos Health Inc. saw its stock rise 6.09% to $0.4961 despite no specific news, reflecting speculative interest and momentum trading in the micro-cap healthcare sector.
Entera Receives FDA Qualification of Total Hip BMD as a Key Endpoint for Osteoporosis Drug Development
- FDA Qualification: Entera Bio has received broad FDA qualification for total hip bone mineral density (BMD) as a validated regulatory endpoint, which will simplify the pathway for its NDA submission for EB613, potentially accelerating drug development timelines.
- Market Demand: With over 200 million women globally estimated to have osteoporosis and largely undertreated, this regulatory reform by the FDA presents Entera with a significant opportunity to address this unmet medical need, enhancing its competitive position in the market.
- Clinical Trial Innovation: EB613, as the first oral once-daily anabolic treatment, has successfully met all biomarker and BMD endpoints in a Phase 2 trial involving 161 patients, demonstrating its potential to lower fracture risk and possibly transform the treatment landscape for osteoporosis.
- Strategic Vision: Entera's CEO emphasized the company's commitment to improving the quality of life for osteoporosis patients through innovative therapies, with FDA support likely facilitating broader market access by 2025, furthering the democratization of osteoporosis treatment globally.
Entera Bio Reports Financial Results and Business Developments for Q3 2025
FDA Agreement on EB613: The FDA has approved Entera Bio's proposal for a Phase 3 study of EB613, focusing on bone mineral density (BMD) as the primary endpoint, which aims to support a New Drug Application for the first oral treatment for osteoporosis in post-menopausal women.
Phase 2 Data Highlights: Recent presentations at major medical conferences showcased EB613's significant efficacy in increasing both trabecular and cortical bone indices in younger post-menopausal women, indicating rapid bone strengthening comparable to existing injectable treatments.
Next-Generation EB613 and Other Programs: Entera is on track to initiate a Phase 1 trial for a next-generation version of EB613 in late 2025, while also advancing oral therapies for short bowel syndrome and obesity in collaboration with OPKO Health.
Financial Overview: For the quarter ending September 30, 2025, Entera reported a net loss of $3.2 million, with cash reserves expected to support operations through mid-2026, reflecting ongoing investments in research and development for its innovative oral peptide therapies.
Entera Bio Unveils Promising New Clinical Results from EB613 Phase 2 Trial Showing Notable Bone Density Gains in Early Postmenopausal Women
EB613 Efficacy: New clinical data presented at NAMS 2025 shows that EB613, an oral anabolic treatment, significantly increases bone mineral density (BMD) in both early postmenopausal women and those more than 10 years post-menopause, addressing a critical need in osteoporosis care.
Phase 3 Study Plans: Entera Bio plans to initiate a global Phase 3 study for EB613 following FDA concurrence in July 2025, aiming to provide a first-in-class oral therapy for postmenopausal women at high risk for fractures.
Patient Access and Compliance: The oral formulation of EB613 could enhance patient access to anabolic therapy, which is often underutilized due to the challenges associated with injectable treatments, potentially transforming osteoporosis management.
Company Overview: Entera Bio is focused on developing oral peptide therapies for unmet medical needs, with EB613 being its lead candidate for osteoporosis, alongside other innovative oral treatments for various conditions.
Entera Bio Reveals Encouraging Pharmacokinetic Data for Its First Oral GLP-2 Treatment
Encouraging Pharmacokinetic Data: Entera Bio Ltd. reported promising pharmacokinetic results for its oral GLP-2 analog therapy, OPK-8801003, aimed at treating short bowel syndrome (SBS), which could offer a more convenient alternative to the current injectable treatment, Gattex.
Market Potential and Investor Sentiment: The positive findings may enhance investor confidence in Entera's pipeline and the N-Tab oral peptide platform, as the therapy addresses a significant unmet need in a rare disease market valued at nearly $800 million annually, despite Entera's stock facing recent declines.
