Rockwell Med Inc Stock Price, News & Analysis

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.

Rockwell Medical (RMTI) has appointed Andrea Heslin Smiley, an experienced life sciences executive, to its Board of Directors as of December 11, 2020. With nearly 30 years in the biopharmaceutical field, Ms. Smiley brings a strong background in patient adherence and product commercialization. Her expertise is expected to enhance the value of Rockwell's Triferic® therapies and support its expansion into the home infusion market. This leadership change aims to bolster the company’s strategic direction and reinforces its commitment to advancing iron deficiency treatments.

Rockwell Medical reported Q3 2020 financial results, achieving revenue of $15.3 million, a slight decline of 0.8% from the previous year. The company ended the quarter with $67.3 million in cash and equivalents, bolstered by a $35 million registered direct offering. Rockwell plans to launch Triferic® AVNU in Q1 2021 and enroll the first patient for its Phase 3 trial in China. Additionally, they aim to expand the FPC platform for new indications. The net loss for the quarter was $7.4 million, marking an improvement over last year's loss.

Rockwell Medical, a biopharmaceutical company, will host a conference call on November 9, 2020, at 4:30 p.m. ET, to discuss its financial results for Q3 2020 and recent operational developments. Interested participants can join by dialing (877) 383-7438 for local access or (678) 894-3975 for international access, with a conference ID of 7679074. The call will also be available via live webcast. Rockwell Medical specializes in iron deficiency treatments for patients with end-stage kidney disease through its FDA-approved products, Triferic Dialysate and Triferic AVNU.

Rockwell Medical (Nasdaq: RMTI) announced that two abstracts have been accepted for poster presentations at the ASN Virtual Kidney Week 2020 from October 20 to 25. The abstracts focus on the use of Triferic in hemodialysis patients, highlighting its role in maintaining hemoglobin levels and reducing the need for IV iron. Triferic is FDA-approved and aims to transform iron deficiency treatment in end-stage kidney disease patients.

Rockwell Medical (RMTI) announced new indications for its ferric pyrophosphate citrate (FPC) platform during a recent conference call. The company is pursuing development for treating iron deficiency anemia (IDA) in home infusion patients and assessing FPC's potential for acute heart failure. A Type C meeting with the FDA is anticipated in Q1 2021 for home infusion and in H2 2021 for acute heart failure. Rockwell Medical remains well-capitalized to fund both its dialysis business and clinical advancements, with market opportunities for IDA treatment estimated at $600 million annually.

Rockwell Medical (RMTI) announced a registered direct offering of 23,178,809 common stock shares and accompanying short-term warrants, priced at $1.51 per share. This transaction is expected to yield approximately $35 million in gross proceeds. The funds will be directed towards advancing the development of ferric pyrophosphate citrate for anemia treatment, particularly in home infusion, alongside general corporate purposes. The offering is projected to close around September 25, 2020, subject to customary conditions.