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May 28, 2014
08:05 EDTRMTIRockwell Medical announces FDA acceptance for filing of Triferic NDA
Rockwell Medical announced that its New Drug Application, or NDA, for Triferic has been accepted for filing by the FDA. Triferic is the company's iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis. 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.
News For RMTI From The Last 14 Days
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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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