FDA Grants Priority Review to REZZAYO Prophylaxis sNDA, PDUFA Set for Q1 2027
CRMD sits 22% above its 52-week low of $6.125.
Summary
The FDA accepted for filing CorMedix's supplemental NDA to expand REZZAYO into prophylaxis of invasive fungal disease in allogeneic stem-cell transplant patients, and granted Priority Review with a PDUFA date in Q1 2027. The application was submitted by global partner Mundipharma and rests on the Phase III ReSPECT study, whose positive topline data CorMedix reported in April. This is a label-expansion opportunity on an already-marketed drug, not a new asset, and the company is targeting promotional launch in H2 2027 if approved. Acceptance and Priority Review do not assure approval, and the filing itself carries no new financial figures; the real value hinges on the Q1 2027 action date. CorMedix's Q2 filing showed strong revenue growth alongside an unremediated material weakness, so execution and disclosure quality remain a separate overhang.
At the time of this announcement, CRMD was trading at $7.45 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $565.9M. The 52-week trading range was $6.13 to $13.02. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.