Rockwell Medical Submits Additional Data For IND Application For Iron Deficiency Candidate

  • Rockwell Medical Inc RMTI has provided the FDA with the supplemental data requested by the agency in December 2021 for its pending Investigational New Drug (IND) application of Ferric Pyrophosphate Citrate (FPC) for iron deficiency.
  • The IND supports the proposed Phase 2 trial of FPC for treating iron deficiency anemia and maintaining hemoglobin in patients receiving infusion therapy in the home setting.
  • The additional data relate to the physical, chemical, and microbiological stability of FPC in support of the suggested method of administration in the Phase 2 protocol.
  • Also Read: Why Are Rockwell Medical Shares Surging Wednesday?
  • The FDA has 30 days to review the additional data. The company would expect the trial to start shortly after the review period ends.
  • Separately, Rockwell Medical announced a 1-for-11 reverse split effective at 12:01 a.m. Eastern Time on May 13.
  • At Rockwell's Annual Meeting of Stockholders held on May 9, the company's stockholders approved the Reverse Stock Split ratio of not less than 1-for-2 and not more than 1-for-15.
  • Price Action: RMTI shares are down 33.40% at $0.21 during the market session on the last check Thursday.

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