Rockwell Med Inc Stock Price, News & Analysis

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 A live webcast will be available on the company’s investor website, with an archived version accessible for 30 days following the event.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.

Rockwell Medical, Inc. (Nasdaq: RMTI) announced a poster presentation titled Management of Iron Deficiency Anemia in Home Parenteral Nutrition Patients at the NHIA 2022 Annual Conference in Nashville from March 12-16. The presentation will address challenges and opportunities in managing iron deficiency anemia in home care settings. Timothy T. Chole, SVP of Sales & Marketing, will present alongside notable co-authors. For more details, the poster will be accessible on the company's website post-presentation. Rockwell continues to develop its Ferric Pyrophosphate Citrate platform for transformative treatments for iron deficiency.