Entera Bio Reveals Clinical Findings from EB613 Phase 2 Study
Clinical Data Presentation: Entera Bio presented new clinical data from a post-hoc analysis of its Phase 2 trial for EB613 at the 2025 North American Menopause Society Annual Meeting, highlighting its potential as the first oral bone-building therapy for postmenopausal women at high risk for fractures.
Significant BMD Improvements: The analysis showed that EB613 at a 2.5 mg dose resulted in significant increases in bone mineral density (BMD) at key sites (lumbar spine, total hip, femoral neck) in early postmenopausal women, comparable to improvements seen in women more than 10 years post-menopause.
Addressing Barriers in Osteoporosis Care: The oral formulation of EB613 addresses major barriers in osteoporosis treatment, such as the inconvenience of injectable therapies and high costs, potentially improving patient access and compliance.
Expert Endorsement: Dr. Steven Goldstein emphasized the importance of these findings for fracture prevention in early postmenopausal women, noting the consistency of BMD response across different stages of menopause.
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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.






