相关临床试验
6
0 进行中
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2
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1
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N/A
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2
33.3%
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1
16.7%
招募中
2
33.3%
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16.7%
- Airway Therapeutics appointed Joe Todisco, Chairman and CEO of CorMedix Inc., to its Board of Directors to support the advancement of zelpultide alfa through late-stage development and commercialization preparation. - Todisco brings over two decades of pharmaceutical industry leadership experience, including expertise in hospital channel commercialization where Airway expects to launch its lead product for bronchopulmonary dysplasia (BPD). - Zelpultide alfa is currently in late-stage clinical development for preventing BPD in very preterm infants, a condition with no approved preventive therapies. - The appointment positions Airway Therapeutics for its next growth phase as it prepares to commercialize its platform biologic across multiple disease settings and age groups.
- CorMedix announced completion of enrollment in the global Phase III ReSPECT trial evaluating REZZAYO (rezafungin) for preventing fungal infections in adult patients undergoing allogeneic blood and marrow transplantation. - The study compares once-weekly rezafungin dosing versus standard antimicrobial regimens, with the primary endpoint of fungal-free survival at day 90 and topline results expected in Q2 2026. - REZZAYO represents a significant market opportunity with an estimated 130,000 patients constituting the addressable market for antifungal prophylaxis in the U.S. and a total addressable market exceeding $2 billion. - The drug currently has orphan drug exclusivity through 2035 and patent coverage through 2038, positioning CorMedix for potential FDA approval in this high-risk patient population with critical unmet medical needs.
- CorMedix invested $5 million in Talphera as part of a $29 million private placement to fund completion of the Phase 3 NEPHRO CRRT study for Niyad, a breakthrough-designated anticoagulant. - Niyad represents a potential first-in-class FDA-approved regional anticoagulant for continuous renal replacement therapy, targeting an estimated 165,000 acute kidney injury patients annually. - The strategic partnership grants CorMedix exclusive acquisition negotiation rights following Phase 3 results and a board seat, with Niyad approval anticipated in second half 2026.
- CorMedix has entered a definitive agreement to acquire Melinta Therapeutics for $300 million, adding seven marketed infectious disease products to its portfolio. - The acquisition includes Rezzayo, currently approved for candidemia treatment with an ongoing Phase III study for fungal infection prophylaxis expected to complete in first half 2026. - Melinta's portfolio generated $120 million in revenue in 2024 and is projected to deliver $125-135 million for fiscal year 2025. - The transaction is expected to achieve annual run-rate synergies of $35-45 million and be highly accretive in 2026.
- CorMedix reported preliminary unaudited net revenue of approximately $31 million for Q4 2024 and $43 million for FY 2024, exceeding previous guidance. - The company is expanding DefenCath deployment to the inpatient hospital segment in Q1 2025 through a collaboration with Syneos Health. - Enrollment is expected to begin in H1 2025 for a clinical study of DefenCath in Total Parenteral Nutrition (TPN) and in H2 2025 for pediatric hemodialysis. - CorMedix anticipates Q4 2024 adjusted EBITDA to exceed $12 million and holds approximately $52 million in cash and short-term investments as of December 31, 2024.
