Market Overview

FDA Accepts Rockwell Medical's New Drug Application

FDA Accepts Rockwell Medical's New Drug Application

Shares of the thinly traded micro-cap biopharma Rockwell Medical Inc (NASDAQ: RMTI) were advancing solidly Tuesday before falling back into the red. 

What Happened

Rockwell, which works on alleviating anemia resulting from end-stage renal disease and chronic kidney disease, said the FDA accepted its new drug application, or NDA, for its intravenous formulation of Triferic.

Rockwell's first product Dialysate Triferic, which launched in May, is mixed with liquid bicarbonate to deliver iron to patients via the dialysate.

Why It's Important

The IV formulation will allow dialysis centers to administer Triferic to patients regardless of the mode of bicarbonate delivery being used, according to the company.

"If approved, the I.V. formulation would complement Dialysate Triferic and expand the global market potential of our Triferic portfolio," CEO Stuart Paul said in a statement. 

Following the acceptance of the regulatory filing, the FDA set the PDUFA date for March 28, 2020.

Rockwell shares were down 0.21% at $2.38 at the time of publication Tuesday. 

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