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Rockwell Medical Receives Additional FDA Feedback On Anemia Candidate

  • Last week, Rockwell Medical Inc RMTI closed the second $7.5 million tranche of the previously announced DaVita Inc 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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