CorMedix receives FDA priority review for REZZAYO prophylaxis sNDA
CorMedix Therapeutics announced that the U.S. FDA has accepted its supplemental New Drug Application for REZZAYO (rezafungin) to prevent invasive fungal disease and granted Priority Review. The filing, submitted with partner Mundipharma, is supported by positive topline results from the Phase III ReSPECT study in allogeneic stem‑cell transplant patients. The agency set a PDUFA target action date for the first quarter of 2027, and CorMedix plans to begin promotional activities in the second half of 2027 if the indication is approved.
Why it matters
The company says the priority‑review status accelerates the timeline for a potential label expansion, which could broaden REZZAYO's market and drive revenue. Analysts note the stock rose about 0.55% in pre‑market trading following the announcement.
Key facts
- 1The FDA accepted the supplemental New Drug Application for REZZAYO and granted Priority Review. stocktitan.net
- 2The PDUFA target action date is set for Q1 2027. stocktitan.net
- 3The sNDA was submitted by development partner Mundipharma. stocktitan.net
- 4The application is supported by positive topline results from the Phase III ReSPECT study announced in April. stocktitan.net
- 5CorMedix plans to start promotional efforts in H2 2027 if the indication is approved. stocktitan.net
- 6REZZAYO is currently approved for treating candidemia and invasive candidiasis in patients aged 12 years or older. stocktitan.net
Open questions
- Material 5 lists the FDA action date as October 20 2023, which conflicts with the Q1 2027 target date reported by all other sources.
Summary written by AlphAI AI Desk from 7 of 7 sources. Not investment advice. Figures are as stated by the linked sources.