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

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 A live webcast will be available on the company's website, with an archived version accessible for 30 days post-event.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.

Rockwell Medical presented findings at ASN Kidney Week 2021, highlighting positive results from a pilot observational analysis on Triferic (Ferric Pyrophosphate Citrate) for hemodialysis patients. The study showed a 23% reduction in IV iron usage during the first three months, increasing to 81% reduction with a new iron management protocol. Hemoglobin levels remained stable throughout. These results align with prior pivotal trials and suggest potential cost savings in anemia management for dialysis clinics.

Rockwell Medical (Nasdaq: RMTI) announced participation in the H.C. Wainwright 23rd Annual Global Investment Conference, scheduled for September 13-15, 2021. The company's executive management team will present virtually, and the presentation will be available on-demand starting September 13 at 7:00 a.m. ET on their website. Additionally, management will engage in one-on-one meetings with registered investors. Rockwell Medical is focused on innovative treatments for iron deficiency and has two FDA-approved therapies for hemodialysis patients.

Rockwell Medical, Inc. (Nasdaq: RMTI) announced the approval of an option to purchase 350,000 shares of its common stock to Megan C. Timmins, Senior VP and General Counsel. This Inducement Grant, effective August 16, 2021, has an exercise price of $0.61 and will vest over four years in two equal installments. The grant aligns with Nasdaq Listing Rule 5635(c)(4) and is outside the 2018 Long Term Incentive Plan. Rockwell Medical focuses on iron deficiency treatments and is a supplier of hemodialysis concentrate products in the U.S.

Rockwell Medical has announced a licensing agreement with Drogsan Pharmaceuticals to commercialize Triferic in Turkey and extended its distribution contract with Nipro Medical for dialysis concentrates in LATAM and the Caribbean. In Q2 2021, Rockwell reported net sales of $15.1 million, down from $15.9 million in Q2 2020, largely due to pandemic-related impacts. The company identified a gross loss of $0.3 million, with increased operating expenses resulting in a net loss of $8.4 million for the quarter. Cash reserves stand at approximately $41 million, supporting strategic initiatives.

Rockwell Medical (Nasdaq: RMTI) announced a conference call on August 16, 2021, at 4:30 p.m. ET to discuss its financial results for Q2 2021 and operational updates. Investors can join the call by dialing (877) 377-7548 locally or (760) 666-3756 internationally, referencing conference ID 1254179. A live webcast will also be available on the company's investor website with an archived version accessible for 30 days. Rockwell Medical is focused on transforming iron deficiency treatment with its proprietary Ferric Pyrophosphate Citrate technology.

Rockwell Medical (RMTI) has submitted a pre-IND meeting request to the FDA for its Phase 2 clinical trial of Ferric Pyrophosphate Citrate (FPC), aimed at treating iron deficiency anemia in home infusion therapy patients. This segment is rapidly growing, with an estimated 40%-55% of home parenteral nutrition patients being iron deficient. The CEO emphasizes that FPC addresses a significant unmet clinical need. The company is focused on innovating treatments for iron deficiency while managing existing FDA-approved therapies for hemodialysis patients.

Rockwell Medical, Inc. (RMTI) has extended its distribution agreement with Nipro Medical Corporation through May 2024, committing approximately $11.4 million in purchases over three years. This partnership, established in 2008, allows Nipro to distribute Rockwell's dialysis concentrates in Latin America and the Caribbean. Rockwell Medical, a leading supplier of hemodialysis concentrates in the U.S. with an annual revenue of $60 million, anticipates growth in the renal market as more patients undergo hemodialysis.