Business
Rockwell Medical, Inc. Provides First Quarter 2021 Financial and Operational Update
-Home Infusion FPC Program expected to initiate Phase 2 trial in second half of 2021- -Company received marketing approval in Canada for Triferic AVNU™-
About this update from Rockwell Medical, Inc.
[{"type":"text","content":"-Home Infusion FPC Program expected to initiate Phase 2 trial in second half of 2021- -Company received marketing approval in Canada for Triferic AVNU™- -Conference call and webcast on Monday, May 17th at 4:30 p.m. ET- WIXOM, Mich., May 17, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today reported financial results and a business update for the three months ended March 31, 2021. “We continued to drive our business forward in the first quarter,” said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. “We believe our Home Infusion FPC program remains on track for a pre-IND meeting with the FDA expected in the third quarter of this year, with multiple upcoming milestones, including our current expectation that the subsequent initiation of our Phase 2 clinical trial of FPC for the treatment of iron deficiency anemia in adult patients in the home infusion setting will commence in the second half of 2021. We also received marketing approval of Triferic AVNU in Canada, the first international regulatory approval for our intravenous therapy, and continued to generate solid revenue from concentrates, our base business, ending the quarter in a strong cash position.” First Quarter 2021 Operational Highlights Dialysis Business Revenue from hemodialysis concentrates was approximately $15.2 million. Revenue from Triferic was approximately $283,000. Rockwell Medical continues to generate data in clinics showing the benefits of Triferic in real world protocols. The Company announced in April that Triferic AVNU (ferric pyrophosphate citrate injection) received a Notice of Compliance (marketing approval) from Health Canada for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. Rockwell Medical expects Triferic AVNU to become commercially available in Canada during 2022. Home Infusion Program As previously announced, the U.S. Food and Drug Administration (FDA) accepted the Company’s proposed development strategy to pursue an approval via the 505(b)(1) pathway as a novel new drug application (NDA) for FPC for treatment of iron deficiency anemia (IDA) in adult patien...