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

By Vandana Singh
  • Rockwell Medical Inc (NASDAQ: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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Dive Deeper:
The Daily Biotech Pulse: Bristol Myers, BridgeBio Ink Oncology Pact, FDA Nod For Lava Therapeutics Blood Cancer Study And More
Here's a roundup of top developments in the biotech space over the last 24 hours:
Why Veru Shares Are Soaring Today Premarket
In a Pre-EUA meeting, FDA said Veru Inc (NASDAQ:VERU) should submit a request for FDA emergency use authorization for sabizabulin in hospitalized COVID-19 patients.…
Caribou's Lymphoma Candidate Shows 100% Response Rate In Early-Stage Study
Caribou Biosciences Inc (NASDAQ: CRBU) announced initial data from its ANTLER Phase 1 trial for CB-010 in relapsed or refractory B cell non-Hodgkin…
The Daily Biotech Pulse: Veru Shares Up On COVID Candidate Update, FDA Approves Lilly's COVID Treatment, Latest On Sanofi-AstraZeneca RSV Vaccine
Here's a roundup of top developments in the biotech space over the last 24 hours:
One subscription that gives you access to news from hundreds of sites
Why This Analyst Has 'Little Conviction' On CRISPR's Upcoming Trial Data
RBC Capital Markets says it remains on the sidelines given commercial uptake for CRISPR Therapeutics' (NASDAQ: CRSP) sickle cell disease (SCD)/beta-thalassemia (BT) capped…
ACHV: First Quarter 2022 Results
By John Vandermosten, CFA NASDAQ:ACHV READ THE FULL ACHV RESEARCH REPORT
Get all your news in one place