Rockwell Medical, Inc. (DE) - RMTI STOCK NEWS

Rockwell Medical, Inc. (Nasdaq: RMTI) announced that Triferic AVNU received marketing approval from Health Canada for maintaining hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. The company anticipates Triferic AVNU's commercial availability in Canada in 2022, which could benefit over 20,000 Canadians undergoing dialysis. This marks the first international approval for their intravenous therapy and is crucial for expanding their market presence.

Rockwell Medical (Nasdaq: RMTI) presented data at the NHIA 2021 Annual Conference, showcasing the feasibility of managing iron deficiency anemia (IDA) in home parenteral nutrition patients. The study revealed that over 50% of these patients experience IDA, highlighting an unmet clinical need. Despite a strong preference for intravenous (IV) iron among healthcare providers, oral iron remains the first-line therapy. Rockwell Medical plans to initiate a randomized clinical trial to evaluate the safety and efficacy of parenteral iron treatment delivered at home, based on positive prior safety data from FPC.

Rockwell Medical reported its 2020 financial results, achieving revenues of $62.2 million, with a cash balance of $58.7 million at year-end. The company highlighted growth in its dialysis business, particularly through Triferic, which generated approximately $1.1 million in revenue. Cost savings of $296,000 were noted from Triferic's use in clinics. The company is focusing on expanding its FPC technology for treating iron deficiency anemia and acute heart failure. They appointed several industry leaders to their board to strengthen management.

Rockwell Medical, Inc. (Nasdaq: RMTI) will host a conference call on March 31, 2021, at 4:30 p.m. ET to discuss its financial results for the year ended December 31, 2020, along with operational highlights. Interested parties can join by calling (877) 383-7438 or (678) 894-3975, and a live webcast will be available on their investor website. The company focuses on treating iron deficiency and anemia management, particularly in hemodialysis patients. Its FDA-approved therapies, Triferic Dialysate and Triferic AVNU, aim to improve outcomes for this patient demographic.

Rockwell Medical (Nasdaq: RMTI) announced that its executive team will present at the H.C. Wainwright Global Life Sciences Conference on March 9, 2021, at 1:30 p.m. Eastern Time. The pre-recorded presentation will be accessible in the ‘Investors’ section of the Company’s website. Rockwell Medical focuses on transforming iron deficiency and anemia management, particularly in end-stage kidney disease, with FDA-approved treatments Triferic and Triferic AVNU, which uniquely maintain hemoglobin levels in hemodialysis patients.

Rockwell Medical (Nasdaq: RMTI) announced the availability of Triferic AVNU, an FDA-approved IV formulation for iron replacement in hemodialysis patients with chronic kidney disease. Approved in March 2020, Triferic AVNU enhances treatment options for patients by allowing greater flexibility in iron maintenance therapy. This product is distributed via Rockwell Medical and Metro Medical, targeting U.S. dialysis clinics. Triferic and Triferic AVNU are the only approved therapies in the U.S. for maintaining hemoglobin in hemodialysis patients, addressing significant medical needs.

Rockwell Medical (Nasdaq: RMTI) announced that its partner, Jeil Pharmaceutical, submitted New Drug Applications for Triferic AVNU and Triferic Dialysate in South Korea, targeting over 82,000 hemodialysis patients. This milestone is significant for both the company and patients with hemodialysis-dependent chronic kidney disease. Rockwell Medical has an exclusive license agreement with Jeil for Triferic in South Korea, entitling it to milestone payments and royalties on sales.

Rockwell Medical (Nasdaq: RMTI) announced the enrollment of the first patient in a pivotal Phase 3 trial for Triferic Dialysate in China, a significant step towards regulatory approval. With over 600,000 patients receiving hemodialysis in China, this market represents a key opportunity. The trial aims to confirm the efficacy and safety of Triferic in maintaining iron levels for anemic patients with chronic kidney disease. Rockwell's partnership with Wanbang Biopharmaceuticals facilitates commercialization efforts, enhancing the availability of Triferic in this growing market.

Rockwell Medical (Nasdaq: RMTI) announced that its executive management team will present at the H.C. Wainwright BioConnect 2021 Conference. The presentation will be available to the public on January 11, 2021, at 6:00 a.m. ET, and will be archived for 30 days on the company's website. Rockwell Medical focuses on transforming iron deficiency treatment, particularly for end-stage kidney disease patients, through its FDA-approved therapies, Triferic Dialysate and Triferic AVNU. These therapies are designed to replace iron and maintain hemoglobin without increasing iron stores.