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Geron Corporation (Nasdaq: GERN) 27.6% LOWER; today provided updates on the clinical trials being conducted by Janssen Research & Development, LLC, of the telomerase inhibitor imetelstat. Planned internal reviews of initial data from both trials have been completed by Janssen, and both trials are continuing in order to evaluate additional and more mature data.
Neuralstem, Inc. (Nasdaq: CUR) 21.6% HIGHER; announced that on September 7, 2016, it entered into definitive agreements with Tianjin Pharmaceutical Holding Group for the private placement of common stock and convertible preferred stock for gross proceeds of $20,000,000. Neuralstem intends to use the net proceeds from the offering for clinical research and development and general corporate purposes.
Raptor Pharmaceutical Corp. (Nasdaq: RPTP) 20% HIGHER; Horizon Pharma plc (Nasdaq: HZNP) and Raptor Pharmaceutical Corp. (Nasdaq: RPTP) announced the companies have entered into a definitive agreement under which Horizon Pharma will acquire all of the issued and outstanding shares of Raptor Pharmaceutical Corp. common stock for $9.00 per share in cash, for an implied fully diluted equity value of approximately $800 million. The transaction is expected to close in the fourth quarter of 2016.
Celsion Corporation (Nasdaq: CLSN) 13.2% HIGHER; announced that the National Institutes of Health (NIH) has conducted an independent retrospective analysis of data from the intent-to-treat population of the Companys HEAT Study, a 701-patient study investigating ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC). The findings of the NIH study will be presented during an oral session on Monday, November 28, 2016 at 1:50 pm CT during the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) to be held on November 26 December 2, 2016 in Chicago, IL. Celsion is currently studying the use of RFA as a heat source both for tumor ablation and to activate ThermoDox® as a means of treating the area surrounding the tumor, where untreated tumor may be present.
Novocure (Nasdaq: NVCR) 11.7% HIGHER; announced that long-term survival analysis of the full 695 patient dataset from the phase 3 pivotal EF-14 trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) will be presented as a late-breaking oral presentation at the 21st Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) in Scottsdale, Arizona, on Friday, Nov. 18, 2016.
Amarin Corporation plc (NASDAQ: AMRN) 11.7% LOWER; announced that, as expected, the independent data monitoring committee (DMC) has completed its review of the first pre-specified interim efficacy analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. The 8,175-patient outcomes study is evaluating whether treatment with Vascepa® (icosapent ethyl) reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors.
Polaris Industries Inc. (NYSE: PII) 11.6% LOWER; provided an update to its full-year guidance. The Company now expects full-year 2016 earnings to be in the range of $3.30 to $3.80 per diluted share, $2.50 to $2.70 per diluted share lower than previously expected of which approximately two-thirds is expected to be incurred in the third quarter. Polaris also expects total Company sales for the full-year 2016 to be down in the mid to high-single digit percent range compared to previously issued guidance of flat to down two percent. *** The Street sees FY16 EPS of $6.01.
RetailMeNot Inc. (NASDAQ: SALE) 6.2% LOWER; Morgan Stanley downgraded from Equalweight to Underweight with a price target of $8.60 (unchanged).
Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) 5.8% HIGHER; announced the topline results of its Phase 2 clinical trial of FMX103 for the treatment of papulopustular rosacea. Statistically significant differences were demonstrated for improvement in the primary and secondary efficacy endpoints (reduction in the number of inflammatory lesions papules and pustules and improvement of Investigator Global Assessment score) for FMX103 compared with the vehicle-treated group.
The Rubicon Project, Inc. (NYSE: RUBI) 5% LOWER; Morgan Stanley downgraded from Equalweight to Underweight with a price target of $8.00 (from $11.00).
TrueCar (NASDAQ: TRUE) 4.4% LOWER; Morgan Stanley downgraded from Equalweight to Underweight with a price target of $6.40 (from $5.00).
Potash Corporation (NYSE: POT) 2.3% HIGHER; Agrium Inc. (NYSE: AGU) and Potash Corporation of Saskatchewan Inc. (NYSE: POT) announced that they have agreed to combine in a merger of equals to create a world-class integrated global supplier of crop inputs.
QIAGEN (Nasdaq: QGEN) 2.3% LOWER; commented on a decision issued late on Friday, September 9, by the U.S. District Court for the Northern District of California, San Francisco Division, in which the Court granted the motion for a preliminary injunction against the Company as part of patent litigation filed by a competitor. The lawsuit alleges infringement of U.S. Patent 7,566,537 by QIAGEN's GeneReader NGS System.
Harley-Davidson (NYSE: HOG) 2% LOWER; down on PII's warning
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