Truist Securities Reiterates CorMedix (CRMD) at Buy, Calls DefenCath NDA Resubmission a "Huge Relief"

Truist Securities analyst Joon Lee reiterated a Buy rating and $27.00 price target on CorMedix (NASDAQ: CRMD), following the company's announcement of resubmission of DefenCath NDA.

The analyst quotes: "This morning CRMD disclosed it has resubmitted the DefenCath NDA. Recall FDA issued CRL almost exactly 1 year ago on March 1, 2021 due to CMC related issues (our take HERE). Importantly, no deficiencies related to safety or efficacy of DefenCath were noted in the CRL and we note that FDA did not request an AdCom for the risk/benefit evaluation of DefenCath, which was highly positive going into PDUFA.

Since then, the Street learned that the FDA requested an "in-process qualification study" / "manual extraction study" which necessitated production of new batches and new stability tests. Previously, the mgmnt stated that the NDA can be resubmitted without completion of full stability test. Also, CRMD disclosed that a need for in-person site visit will be determined post-NDA resubmission.

With some drama and recent change of leadership, today's news is a huge relief. We look forward to notice of NDA acceptance within 2 months time followed by plans for TDAPA application"

For an analyst ratings summary and ratings history on CorMedix click here. For more ratings news on CorMedix click here.

Shares of CorMedix closed at $4.02 yesterday.

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