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 announced a $15 million securities purchase agreement with Armistice Capital Master Fund. The deal involves $12 million of common stock and $3 million in a private placement. Each share is priced at $1.515, with warrants priced at $1.39, valid for 5.5 years. Proceeds are intended for restructuring its dialysis business and advancing ferric pyrophosphate citrate for treating iron deficiency anemia. Following the agreement, a $7.5 million investment from DaVita, Inc. is expected.
Rockwell Medical, Inc. (Nasdaq: RMTI) announced that CEO Russell Ellison will present at H.C. Wainwright's Annual Global Life Sciences Conference in Miami, Florida, on May 24 at 3:30 PM ET. The company specializes in biopharmaceuticals focused on iron deficiency and anemia management, with FDA-approved therapies for hemodialysis patients. A video of the presentation will be available the following day on their website and archived for 90 days. Rockwell Medical also develops its Ferric Pyrophosphate Citrate platform for broader iron deficiency treatments.
Rockwell Medical reported first quarter 2022 net sales of $16.1 million, a 4.2% increase year-over-year, primarily driven by dialysis concentrate sales. The company submitted supplemental data to the FDA for its Phase 2 trial of Ferric Pyrophosphate Citrate (FPC) in home infusion therapy. An amended supply agreement with DaVita includes a $7.5 million investment to enhance profitability. Notably, enrollment for the pivotal Phase 3 trial of Triferic® in China was completed ahead of schedule. However, the company experienced a gross loss of $0.8 million due to inflationary pressures.
Rockwell Medical, Inc. (Nasdaq: RMTI) has submitted supplemental data to the FDA for its Investigational New Drug (IND) application regarding Ferric Pyrophosphate Citrate (FPC). This data supports a proposed Phase 2 clinical trial aimed at treating iron deficiency anemia in patients receiving home infusion therapy. The FDA has a 30-day review period for this submission. If approved, the trial may commence shortly after the review concludes. The intended innovation aims to enhance patient care by reducing the need for clinic visits.
Rockwell Medical, Inc. (RMTI) announced a 1-for-11 reverse stock split effective May 13, 2022, to comply with Nasdaq minimum bid price requirements. This decision follows approval from stockholders during the 2022 Annual Meeting on May 9, 2022. The split means that every 11 shares will convert into one new share, affecting stock options and equity awards proportionately. No fractional shares will be issued; instead, cash will be paid for any fractional share entitlement. The new CUSIP number for the shares post-split will be 774374300.
Rockwell Medical, Inc. (Nasdaq: RMTI), based in Wixom, Michigan, will host a conference call on May 16, 2022, at 4:15 PM ET to discuss its financial results for the first quarter ended March 31, 2022, along with recent operational highlights. Interested participants can join by dialing (877) 383-7438 for local calls or (678) 894-3975 for international access, using conference ID 2599375. A live webcast will be available on the company’s investor website, with an archived version accessible for 30 days following the event.
Rockwell Medical announced the completion of patient enrollment ahead of schedule in its pivotal Phase 3 clinical trial for Triferic Dialysate in China, with 442 participants enrolled. This milestone supports their New Drug Application to the National Medical Products Administration (NMPA), expected in Q3 2023. Triferic is aimed at treating iron deficiency in hemodialysis patients. With over 600,000 patients receiving hemodialysis in China, the company sees significant market potential. The trial is designed to confirm Triferic's efficacy and safety in maintaining hemoglobin levels.
Rockwell Medical, a biopharmaceutical company focused on iron deficiency and anemia treatment, will present at the Noblecon18 Annual Investor Conference on April 21, 2022, at 10:00 AM ET in Hollywood, Florida. A video webcast will be available the next day on the Rockwell Medical website and will remain archived for 90 days. Rockwell Medical is known for its Ferric Pyrophosphate Citrate platform and offers FDA-approved solutions for patients on hemodialysis, alongside plans to expand into home infusion settings.
Rockwell Medical (RMTI) announced a significant partnership expansion with DaVita (DVA), featuring a $7.5 million initial equity investment and an amended supply agreement. This collaboration aims to stabilize Rockwell's concentrates business, enabling profitable operation while ensuring reliable supply for dialysis treatment. The agreement includes a potential additional $7.5 million investment, contingent on meeting certain conditions. Rockwell Medical emphasizes its vital role in the dialysis sector, with ambitions to broaden its business through ongoing discussions with other key customers.
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