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Stock Market & Financial Investment News

News Breaks
March 27, 2014
07:08 EDTPSDV, ALIMpSivida announces resubmission of NDA for ILUVIEN
pSivida Corp. (PSDV) announced that the New Drug Application for ILUVIEN for the treatment of chronic Diabetic Macular Edema has been resubmitted to the U.S. Food and Drug Administration. In the resubmission, pSividas licensee, Alimera Sciences (ALIM), responded to questions raised in the FDAs October 2013 complete response letter and provided a safety update, which included commercial experience with ILUVIEN in Europe. Alimera is awaiting the FDAs acceptance of the resubmission and a Prescription Drug User Fee Act date. pSivida will report that information when it becomes available.
News For PSDV;ALIM From The Last 14 Days
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September 30, 2014
13:52 EDTALIMAlimera Sciences receives $25M advance from Hercules Technology
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11:15 EDTALIMHigh option volume stocks
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September 29, 2014
10:30 EDTPSDV, ALIMHigh option volume stocks
High option volume stocks: RGEN ALIM TIBX MYCC RDWR ATHL DWA ASNA PSDV BGC
09:52 EDTALIMAlimera Sciences to host conference call
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09:20 EDTALIM, PSDVOn The Fly: Pre-market Movers
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07:32 EDTALIMAlimera Sciences provides details on FDA approval of Iluvien
Alimera Sciences announced that it will hold a conference call to provide additional information regarding the recent approval by the FDA of ILUVIEN for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. ILUVIEN was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery. The Company expects to begin selling ILUVIEN in the U.S. during the first quarter of 2015.
September 26, 2014
16:47 EDTALIMAlimera Sciences up 27% after hours following FDA approval for Iluvien
16:18 EDTALIMAlimera Sciences receives FDA approval for Iluvien
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16:13 EDTPSDV, ALIMpSivida announces FDA approval of ILUVIEN
pSivida (PSDV) announced that the U.S. FDA has approved ILUVIEN for the treatment of diabetic macular edema. It is indicated for patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. A single injection of the ILUVIEN micro-insert provides sustained treatment of DME for 36 months. Approximately 560,000 people in the U.S. are estimated to have clinically significant DME, the most frequent cause of vision loss in individuals with diabetes and the leading cause of blindness in young and middle-aged adults in developed countries. ILUVIEN is expected to be commercially available in the U.S. in early 2015. FDA approval of ILUVIEN entitles pSivida to a $25M milestone from its licensee Alimera Sciences (ALIM). pSivida will also be entitled to 20% of the net profits from sales of ILUVIEN in the U.S.
15:46 EDTPSDV, ALIMOptions expected to be active next week
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15:33 EDTPSDVpSivida trading halted, pending news
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15:33 EDTALIMAlimera Sciences trading halted, pending news
14:31 EDTPSDVpSivida volatility elevated
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07:37 EDTPSDV, ALIMFDA PDUFA Date for Alimera Sciences and pSivida's Iluvien is September 26, 2014
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September 25, 2014
17:01 EDTALIMGreat Point Partners reports 6.11% passive stake in Alimera Sciences
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12:50 EDTALIMAlimera Sciences volatility elevated into PDUFA date for Iluvien
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September 23, 2014
10:23 EDTPSDVHigh option volume stocks
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09:37 EDTPSDVActive equity options trading on open
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06:06 EDTALIMAlimera Sciences enters $35M at-the-market agreement with Cowen
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