Tuesday, CorMedix Inc
resubmitted New Drug Application for DefenCath to the FDA, and the submission has been acknowledged as received for processing.
The company looks forward to providing additional updates as we progress toward potential approval in 2023.
JMP Securities has increased the price target from $16 to $19, with a Market Outperform rating.
The analyst remains confident that all outstanding complete response letter items have been fully addressed, and the base case scenario is for a Class II, 6-month review, with PDUFA's target action date in mid-November.
The company also provided its 1Q23 financial update and has a current cash position of ~$59 million which management views as sufficient to fund operations until 1H 2024.
The analyst notes that as part of commercial readiness activities in the inpatient setting, the company has begun to engage with pharmacy and technology committees at multiple health organizations.
These interactions will also include close collaborations to establish institution-specific baseline numbers of infections.
It notes that the company has already secured reimbursement for the inpatient setting through the CMS NTAP program, with the final IPSS confirmation expected in late summer.
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