Rockwell Medical Receives Additional FDA Feedback On Anemia Candidate
Last week, Rockwell Medical Inc (NASDAQ: RMTI) closed the second $7.5 million tranche of the previously announced DaVita Inc (NYSE: DVA) stock purchase agreement of up to $15 million in convertible preferred stock in two tranches.
This investment, in addition to the recently announced $15 million financings, brings the total gross amount raised by Rockwell this quarter to $30 million.
Related: Rockwell Medical Submits Additional Data For IND Application For Iron Deficiency Candidate.
The company also said the eventual commercial presentation of Ferric Pyrophosphate Citrate (FPC) in home infusion patients for iron deficiency anemia and maintaining hemoglobin is still in development.
Hence, the planned Phase 2 proof of concept study design requires three units of the existing FDA-approved IV product to be compounded into a single unit for each patient dose.
As this is a necessary step, the FDA requested that Rockwell perform a microbial challenge study. Successful completion of this study will add a layer of safety for clinical trial patients.
Price Action: RMTI shares closed 3.76% lower at $1.28 on Wednesday.
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