Welcome to our dedicated page for Rockwell Medical (DE) news (Ticker: RMTI), a resource for investors and traders seeking the latest updates and insights on Rockwell Medical (DE) stock.
Rockwell Medical, Inc. (DE), trading under the symbol RMTI, is a leading biopharmaceutical company dedicated to addressing the needs of patients with end-stage renal disease (ESRD) and chronic kidney disease (CKD). The company has positioned itself at the forefront of renal care through its innovative products and services focusing on iron replacement, secondary hyperparathyroidism, and hemodialysis.
One of Rockwell Medical's groundbreaking therapies is Triferic, the first and only FDA-approved drug designed to replace iron and maintain hemoglobin levels in hemodialysis patients with anemia. Triferic works during each dialysis session by replacing the 5-7 mg iron loss that is typical in all patients, thereby maintaining their iron balance. Differing from traditional intravenous (IV) iron products, Triferic binds immediately to transferrin (the body's iron carrier) and is swiftly transported to the bone marrow for incorporation into hemoglobin. This unique mechanism ensures no increase in ferritin (stored iron and inflammation) and eliminates the risks of anaphylaxis, addressing a critical unmet need for functional iron deficiency (FID) in ESRD patients.
Rockwell Medical is also a prominent supplier of dialysis concentrates in the United States. Their diverse product portfolio includes notable brands such as CitraPure citric acid concentrate, RenalPure liquid acid concentrate, and SteriLyte bicarbonate concentrate. These products are essential for dialysis providers, helping to ensure that patients receive the necessary treatments for effective dialysis.
The company's commitment to innovation and quality is reflected in its ongoing projects and recent achievements. Rockwell Medical continues to focus on expanding its product line and enhancing its manufacturing processes to meet the evolving needs of the renal care market. Financially, the company maintains a robust position with strategic partnerships and collaborations that further bolster its market presence and capabilities.
For those interested in the latest updates and developments regarding Rockwell Medical, Inc., the company's news section provides current information on performance, events, and significant milestones.
Rockwell Medical announces the approval of two product forms of Triferic® in South Korea by Jeil Pharmaceutical. The Triferic Dialysate is now approved for maintaining hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). This approval offers nephrologists an effective option for treating HDD-CKD, which is increasingly prevalent in South Korea, ranking 4th globally. Triferic's administration could reduce nursing time and enhance patient safety in dialysis clinics, especially during the COVID-19 pandemic.
Rockwell Medical (NSD:RMTI) has secured regulatory approval for Triferic Injection in South Korea through its partner, Jeil Pharmaceutical. This milestone allows Rockwell to commercialize Triferic in the region, enhancing its revenue prospects. The company will receive an upfront fee and be entitled to milestone payments and royalties on net sales. Sales are expected to commence in mid-2022, indicating a strong growth avenue for Rockwell Medical.
Rockwell Medical has received regulatory approval from the Ministry of Food and Drug Safety in South Korea for its iron therapy product, Triferic, targeting the 82,000+ hemodialysis patients annually. An exclusive commercialization agreement with Jeil Pharmaceutical allows for the launch of Triferic and Triferic AVNU in mid-2022. This marks a significant step in expanding Rockwell's global reach, with potential milestone payments and royalties boosting its financial prospects. Both Triferic formulations are designed to maintain hemoglobin levels without increasing iron stores, addressing a critical need in end-stage kidney disease treatment.
Rockwell Medical (Nasdaq: RMTI) announced that its executive management team will present at the H.C. Wainwright BioConnect 2022 Conference. The presentation will be available for on-demand listening starting January 10, 2022, at 7:00 a.m. ET on the Company’s website. Rockwell Medical focuses on improving treatment for iron deficiency and anemia, with its Ferric Pyrophosphate Citrate (FPC) technology platform aimed at various disease states. The Company has two FDA-approved therapies for hemodialysis patients and is expanding FPC for use outside of dialysis.
Rockwell Medical (RMTI) announced FDA feedback on its IND application for a Phase 2 clinical trial of Ferric Pyrophosphate Citrate (FPC) to treat iron deficiency anemia in home infusion settings. The FDA has requested additional data on microbiology and short-term stability, which Rockwell plans to submit in H1 2022. The trial aims to offer a novel dosing regimen tailored for home healthcare, potentially reducing clinic visits for patients. The company is committed to refining its approach with the FDA’s guidance to enhance patient convenience and care.
Rockwell Medical, Inc. (Nasdaq: RMTI) announced pivotal findings published in the Journal of Bioequivalence & Bioavailability regarding the co-administration of Ferric Pyrophosphate Citrate (FPC, Triferic®) with unfractionated heparin (UFH) during hemodialysis. The study confirmed no significant drug-drug interactions affecting anticoagulation efficacy. Notably, over 1.6 million doses of FPC have been safely administered, supporting its FDA-approved use to maintain hemoglobin in hemodialysis patients. Triferic represents a significant advancement in managing iron deficiency in this population.
Rockwell Medical (RMTI) reported third-quarter net sales of $16.0 million, reflecting a 6% sequential and 5% year-over-year increase. The growth was mainly driven by dialysis concentrates, which generated approximately $15.7 million. The company submitted an Investigational New Drug application for Ferric Pyrophosphate Citrate (FPC), targeting iron deficiency anemia treatment in patients receiving home infusion. It also presented real-world evidence data at ASN Kidney Week 2021, showing the effectiveness of Triferic in maintaining hemoglobin levels in chronic hemodialysis patients.
Rockwell Medical (RMTI) announced the approval of option grants for two new employees, allowing them to purchase a total of 75,000 shares of common stock. This was done as an inducement for their employment, in line with Nasdaq rules, and the exercise price is set at $0.53, matching the closing stock price on the grant date, November 10, 2021. The options will vest over three years, contingent on continued employment. Rockwell Medical specializes in biopharmaceuticals, focusing on iron deficiency treatments and offers two FDA-approved therapies for hemodialysis patients.
Rockwell Medical (RMTI) announced the submission of an Investigational New Drug (IND) application to the FDA for its Phase 2 clinical trial of Ferric Pyrophosphate Citrate (FPC). This treatment targets iron deficiency anemia in patients undergoing home infusion therapy. The CMO emphasized the inadequacies of current treatment methods for this patient population, which often leads to severe fatigue and health risks. The company aims to expand the use of FPC beyond dialysis, marking a significant milestone in its development pipeline.
Rockwell Medical (Nasdaq: RMTI) announced a conference call scheduled for November 15, 2021, at 4:00 PM ET to discuss its Q3 financial results and operational highlights. Investors can participate by dialing (877) 383-7438 or (678) 894-3975, using conference ID 7697945. A live webcast will be available on the company's website, with an archived version accessible for 30 days post-event. Rockwell specializes in biopharmaceuticals, focusing on iron deficiency treatments and is a major supplier of hemodialysis products in the U.S.
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