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News Breaks
June 9, 2014
08:04 EDTRMTIRockwell wins appeal for determination as small business for Triferic NDA filing
Rockwell Medical announced that it has won its appeal for size determination as a small business and is now working with the U.S. Food & Drug Administration to have its $2.2M PDUFA User Fee for filing its New Drug Application for Triferic refunded. Rockwell expects to receive a check for $2.2M from the Department of Treasury. Rockwell's NDA for Triferic was accepted for filing by the FDA on May 28. 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 Prescription Drug User Fee Act 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 therapy for the treatment of iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease. During the clinical program more than 1,400 patients were treated with Triferic and more than 100K 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.
News For RMTI From The Last 14 Days
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January 29, 2015
10:51 EDTRMTIOptions with decreasing implied volatility
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January 28, 2015
11:41 EDTRMTIRockwell Medical ends loan pact with Hercules Technology
Rockwell Medical disclosed in a regulatory filing that on December 19, the company voluntarily paid off and terminated its Loan and Security Agreement, dated as of June 14, 2013, with Hercules Technology. The payoff amount of $18,902,434.33 included principal, accrued and unpaid interest, fees, costs and expenses payable under the Loan Agreement, including an end of term charge of $1.1M In connection with such repayment, Hercules terminated its security interest in the assets of the company subject to the Loan Agreement. The early repayment was required by the company’s Exclusive Distribution Agreement, dated October , with Baxter Healthcare Corporation.
10:29 EDTRMTIOptions with decreasing implied volatility
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January 27, 2015
10:35 EDTRMTIOptions with decreasing implied volatility
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08:25 EDTRMTIRockwell Medical approval a 'significant positive,' says Summer Street
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January 26, 2015
16:25 EDTRMTIFDA wanted second Rockwell study for ESA benfits, Bloomberg says
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13:30 EDTRMTIRockwell Medical announces Triferic prescribing information
Rockwell Medical announced that Triferic is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. Triferic is not intended for use in patients receiving peritoneal dialysis and has not been studied in patients receiving home hemodialysis, the company added. The label will state, "Observe for signs and symptoms of hypersensitivity during and after hemodialysis and until clinically stable." The label does not include ESA sparing, as Brean Capital predicted earlier when reiterating its Sell rating on shares of Rockwell.
10:30 EDTRMTIOptions with decreasing implied volatility
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10:14 EDTRMTIRockwell Medical commercial uptake to be 'dismal', says Brean Capital
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10:14 EDTRMTIRockwell Medical retracing earlier gains, levels to watch
The stock remains up by over 5.7%, last at $11.46, but is heading steadily lower from earlier highs. At the current price next support is at $11.24, the session low and then at $11.01. Resistance is at $11.72.
09:19 EDTRMTIOn The Fly: Pre-market Movers
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08:06 EDTRMTIRockwell Medical Triferic approved by FDA
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07:51 EDTRMTIRockwell Medical trading halted, news pending
Note that FDA PDUFA date for Rockwell Medical's Triferic was January 24.
January 23, 2015
11:23 EDTRMTIRockwell Medical volatility elevated into PDUFA
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08:56 EDTRMTIFDA PDUFA Date for Rockwell Medical's Triferic is January 24, 2015
08:35 EDTRMTIRockwell Medical a buy ahead of PDUFA tomorrow, says Summer Street
Summer Street says it would be a buyer of Rockwell Medical shares ahead of tomorrow's FDA action date for Triferic. The firm sees an "excellent" chance of approval and believes Rockwell could be well into labeling discussions with the FDA. It has a Buy rating on the stock with a $25 price target.
January 21, 2015
06:15 EDTRMTIRockwell Medical February volatility elevated into PDUFA
Rockwell Medical February call option implied volatility is at 132, March is at 101, May is at 96; compared to its 26-week average of 9- according to Track Data, suggesting large price movement into PDUFA Date for Triferic on January 24.

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