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Rockwell Medical (NASDAQ: RMTI) 27.7% HIGHER; announced successful top-line results from the long-term CRUISE-1 Phase 3 efficacy study of SFP. SFP is the Company's late-stage investigational iron-delivery drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis. In the Phase 3 efficacy study, SFP met the primary endpoint, demonstrating a statistically significant mean change in hemoglobin from baseline to End-of-Treatment. Additionally, SFP met key secondary endpoints, including maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin. This long-term study is the first of two identical Phase 3 efficacy studies to provide clinical data required for the Company to file a New Drug Application (NDA) with the U.S. FDA.
Bridgepoint Education, Inc. (NYSE: BPI) 25.3% HIGHER; Ashford University, has been granted initial accreditation for five years by the Accrediting Commission for Senior Colleges and Universities of the Western Association of Schools and Colleges (WASC). The WASC Commission Action Letter stated "The Commission found that the University has responded to Commission concerns and judges that it is now in substantial compliance with Commission standards."
SemiLEDs Corp. (NASDAQ: LEDS) 16% LOWER; reported Q3 EPS of ($0.24), $0.03 worse than the analyst estimate of ($0.21). Revenue for the quarter came in at $3.5 million versus the consensus estimate of $5.17 million. GAAP gross margin for the third quarter of fiscal 2013 was negative 129%, compared with gross margin for the third quarter of fiscal 2012 of negative 11%. Operating margin for the third quarter of fiscal 2013 was negative 278% compared with negative 87% in the third quarter of fiscal 2012.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) 13.4% HIGHER; announced positive top-line results from its ongoing Phase I trial of ALN-TTRsc, a subcutaneously administered RNAi therapeutic targeting the transthyretin (TTR) gene for the treatment of TTR-mediated amyloidosis (ATTR). The company is reporting that ALN-TTRsc achieved robust and statistically significant (p