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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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November 20, 2014
09:21 EDTRMTIOn The Fly: Pre-market Movers
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08:02 EDTRMTIRockwell Medical 6.5M share Secondary priced at $9.00
BofA/Merrill acted as lead book running manager for the offering.
November 17, 2014
18:32 EDTRMTIOn The Fly: After Hours Movers
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16:16 EDTRMTIRockwell Medical proposes $55M common stock offering
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November 12, 2014
10:34 EDTRMTIOptions with decreasing implied volatility
Options with decreasing implied volatility: RMTI RPRX KATE PNK CZR KING TSLA UBNT LOCO GNRC
November 11, 2014
10:39 EDTRMTIOptions with decreasing implied volatility
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November 10, 2014
16:07 EDTRMTIRockwell Medical reports Q3 EPS (10c), consensus (10c)
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15:54 EDTRMTIAmerican Society of Nephrology to hold a conference
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10:17 EDTRMTIOptions with decreasing implied volatility
Options with decreasing implied volatility: RMTI ACHN RPRX ARCP SALE ZU KING UBNT KATE AWAY
November 7, 2014
10:40 EDTRMTIOptions with decreasing implied volatility
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10:11 EDTRMTIHigh option volume stocks
High option volume stocks: CTIC AVG RMTI XLY OLED HON GNW ADP PAYX MDRX
09:16 EDTRMTIOn The Fly: Pre-market Movers
HIGHER: Sears (SHLD), up 22.5% after reporting Q3 same-store sales were flat with prior year, saying company is actively exploring a REIT transaction involving 200-300 owned properties through a rights offering... Gap (GPS), up 2.9% after reporting October same-store sales fell 3%, giving Q3 EPS guidance that beat estimates... Zynga (ZNGA), up 9%, upgraded at Needham following the company's Q3 earnings report... King Digital (KING), up 8.6% after Q3 results top expectations, company announces $150M share repurchase program... ChannelAdvisor (ECOM), up 30% after earnings, guidance, announcing acquisition of U.K. based E-Tale Holdings... Rockwell Medical (RMTI), up 25% after FDA committee recommends Triferic to treat iron loss in certain patients with chronic kidney disease... Repros Therapeutics (RPRX), up 23% following meeting with FDA regarding Androxal NDA filing. LOWER: Salix (SLXP), down 35%, downgraded at Mizuho, Stifel and William Blair after the company reported worse than expected Q3 earnings, gave lower than expected guidance and announced its CFO had resigned... Intercept (ICPT), down 19% after FLINT trial results published... CTI BioPharma (CTIC), down 20% after filing convertible preferred stock offering... Transocean (RIG), down 5% after delaying its Q3 earnings release and conference call, stating the company expects Q3 to include a non-cash charge of $1.97B for impairment of goodwill... General Mills (GIS), down 4% after lowering FY15 outlook. DOWN AFTER EARNINGS: Abercrombie & Fitch (ANF), down 12.6%... Ubiquiti Networks (UBNT), down 17%... Arista Networks (ANET), down 10.5%... First Solar (FSLR), down 6%... Magnum Hunter (MHR), down 2%.
08:11 EDTRMTIOptions expected to be active
Options expected to be active @ CBOE: DIS FSLR RIG RMTI SLXP ZNGA PBR SHLD CP CSX NSC NVDA FSLR

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