Cormedix said the FDA has accepted for filing its supplemental NDA for Rezzayo, rezafungin for injection, and granted priority review, setting a PDUFA target action date in the first quarter of 2027.
The filing seeks approval for prophylaxis of invasive fungal disease in adults undergoing allogeneic HSCT. The application is backed by the Phase III ReSPECT study, which Cormedix said produced positive topline results in April. If the new indication is approved, the company said it is targeting promotional efforts to begin in the second half of 2027.
Rezzayo is already approved in the U.S. for candidemia and invasive candidiasis in adults and pediatric patients 12 years of age or older with limited or no alternative treatment options. The drug has orphan exclusivity through 2035 and patent coverage through 2038 in the U.S.
Cormedix also said the prophylaxis opportunity addresses a patient population at risk for invasive fungal disease, and that it expects to work with partner Mundipharma over the coming months ahead of the FDA action date. The market has reacted to these announcements by moving the company's shares -2.68% to a price of $7.26. Check out the company's full 8-K submission here.
