CRMD - FDA again rejects CorMedix's application for lead candidate DefenCath shares sink ~60%

• CorMedix ( NASDAQ: CRMD ) on Monday said its new drug application for its antibacterial and antifungal solution DefenCath had been rejected by the U.S. FDA for a second time, sending its shares plunging 60.1% to $3 after hours.
• The second rejection of the new drug application (NDA), or the so-called complete response letter, stated that the NDA could not be approved until deficiencies recently conveyed to CRMD's contract manufacturing organization and the supplier of the active pharmaceutical ingredient heparin are resolved to the FDA's satisfaction.
• The FDA also separately conducted a recent inspection at the facility of the company's heparin supplier which resulted in the supplier of the ingredient getting a warning letter due to manufacturing deficiencies.
• The U.S. regulator told CRMD in the complete response letter that the satisfactory resolution of these deficiencies would also be needed to approve the DefenCath NDA.
• CRMD said it had now entered into an agreement with U.S.-based contract manufacturer Alcami Corp, which will serve as an alternative manufacturing site for DefenCath.
• CRMD said it anticipates filing a supplement to its NDA around Q1 2023 end.

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