Last $10.08 USD
Change Today -0.23 / -2.23%
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rockwell medical inc (RMTI) Snapshot

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11/22/13 - $15.85
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rockwell medical inc (RMTI) Details

Rockwell Medical, Inc. operates as an integrated biopharmaceutical company in the United States and internationally. It offers products and services for the treatment of end-stage renal disease, chronic kidney disease (CKD), iron deficiency, secondary hyperparathyroidism, and hemodialysis. The company’s products are used to cleanse patients' blood and replace nutrients lost during the kidney dialysis process. Its lead drug candidates include Triferic, which is in late-stage clinical development for the treatment of iron replacement in dialysis patients; and Calcitriol, a generic active vitamin D for the treatment of secondary hyperparathyroidism in dialysis patients. The company also manufactures, sells, delivers, and distributes hemodialysis concentrates, such as CitraPure citric-acid concentrate, Dri-Sate dry acid, Renal Pure liquid acid concentrate, dry acid concentrate mixing system, RenalPure powder bicarbonate concentrate, and SteriLyte liquid bicarbonate concentrate; and ancillary products, including blood tubing, fistula needles, specialized custom kits, dressings, cleaning agents, filtration salts, and other supplies used by hemodialysis providers. Rockwell Medical, Inc. sells its products directly to hemodialysis providers, as well as through independent sales agents and distributors. The company was founded in 1995 and is based in Wixom, Michigan.

286 Employees
Last Reported Date: 03/7/14
Founded in 1995

rockwell medical inc (RMTI) Top Compensated Officers

Founder, Chairman, Chief Executive Officer, P...
Total Annual Compensation: $941.8K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $456.3K
Chief Medical Officer
Total Annual Compensation: $499.8K
Chief Scientific Officer and Member of Scient...
Total Annual Compensation: $529.5K
Compensation as of Fiscal Year 2013.

rockwell medical inc (RMTI) Key Developments

Rockwell Medical, Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2014

Rockwell Medical, Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2014. For the quarter, the company reported net loss of $3,170,378 or $0.08 per basic and diluted share against $11,863,219 or $0.38 per basic and diluted share a year ago. Sales were $13,033,361 against $12,984,164 a year ago. Operating loss was $2,382,008 against $11,775,630 a year ago. Loss before income tax was $3,170,378 against $11,863,219 a year ago. For the six months, the company reported net loss of $10,975,904 or $0.28 per basic and diluted share against $27,242,943 or $1.04 per basic and diluted share a year ago. Sales were $25,997,013 against $25,320,538 a year ago. Operating loss was $9,407,446 against $27,165,951 a year ago. Loss before income tax was $10,975,904 against $27,242,943 a year ago. Cash used in operating activities was $13,611,724 against $32,834,193 a year ago. Purchase of Equipment was $428,831 against $313,014 a year ago.

Rockwell Medical, Inc., Q2 2014 Earnings Call, Jul 31, 2014

Rockwell Medical, Inc., Q2 2014 Earnings Call, Jul 31, 2014

Rockwell Medical, Inc. Announces FDA Approves $2.2 Million Application Fee Refund for Triferic NDA

Rockwell Medical, Inc. announced that the U.S. Food & Drug Administration (FDA) granted its request for a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee for its New Drug Application (NDA) for Triferic. Rockwell's previous small business waiver request was denied by the Small Business Office of Government Contracting based upon the ruling that the company did not meet the proper size determination criteria, but Rockwell appealed the decision and won. Rockwell will receive a check for $2.2 million from the Department of Treasury within a few weeks. Triferic is the company's iron-replacement drug for treating iron loss in chronic kidney disease patients receiving hemodialysis. Rockwell's NDA for Triferic was accepted for filing by the FDA on May 28, 2014. The acceptance of the NDA indicates the determination by the FDA that the application is sufficiently complete to permit a substantive review. The NDA will be subject to a standard review and will have a PDUFA action date of January 24, 2015. The PDUFA action date is the goal date for the FDA to complete its review of the NDA. The company's NDA seeks approval for the marketing and sale of Triferic as an iron replacement/maintenance therapy for the treatment of iron loss or iron deficiency in adult patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD 5HD). Included in the NDA filing are safety and efficacy data sets derived from the company's Phase 3 registration program, as well as safety and efficacy data from several additional studies comprising the entire clinical program. During the clinical program more than 1,400 patients were treated with Triferic and more than 100,000 individual administrations were given. The results from the clinical trials have shown the potential for Triferic to be an effective and highly-differentiated iron delivery therapy with a safety profile similar to placebo.


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