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Regulatory progress with a clear near-term milestone (Q1 2027 PDUFA) typically triggers upside for biotech names; the potential expansion into HSCT prophylaxis could broaden addressable market and licensing opportunities, especially given positive Phase III data.
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FDA accepted for filing CorMedix's REZZAYO sNDA with Priority Review and a Q1 2027 PDUFA date. The filing is anchored to the Phase III ReSPECT topline results showing rezafungin's efficacy in preventing invasive fungal disease in adults undergoing allogeneic HSCT. If approved, CorMedix plans promotional activity in H2 2027, potentially expanding its antifungal franchise.
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