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

Rockwell Medical, a biopharmaceutical company specializing in iron deficiency treatments, will present at the Aegis Virtual Conference on February 23, 2022, from 1:30 to 2:00 PM ET. The company focuses on innovative therapies including its Ferric Pyrophosphate Citrate (FPC) platform, targeting iron deficiency in various patient populations, particularly those on hemodialysis. Recordings of this presentation will be available on their website from February 23 to 25, 2022. Rockwell Medical is also a leading supplier of hemodialysis concentrates in the U.S.

Rockwell Medical (RMTI) announced on February 14, 2022, the approval of an option grant for a new employee to purchase 10,000 shares of common stock at an exercise price of $0.40, equivalent to the stock's closing price on February 10, 2022. This Inducement Grant was authorized by the majority of independent directors per Nasdaq Listing Rule 5635(c)(4) and will vest over three years. Rockwell Medical is focused on developing treatments for iron deficiency and anemia, with FDA-approved therapies for hemodialysis patients.

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.