By RTT News, October 04, 2013, 12:01:00 AM EDT
(RTTNews.com) - Amarin Corp. plc ( AMRN ) has been notified by the FDA that the panel review of Vascepa in the expanded use as an adjunct to diet in the treatment of adult patients with high triglycerides (200 mg/dL to 499 mg/dL) with mixed dyslipidemia to be held on October 16, 2013 will take place as scheduled despite the shutdown of the U.S. federal government. The FDA's final decision is slated for December 20, 2013.
Vascepa received FDA approval for the reduction of triglyceride levels in adult patients with severe hypertriglyceridemia last July.
AMRN closed Thursday's trading at $6.89, up 3.62%.
Incyte Corp. ( INCY ) touched another high of $41.24 on Thursday before closing at $40.82 after the company announced that in a dose-escalation phase II proof-of-concept clinical trial, its investigational drug INCB39110 achieved efficacy in multiple psoriasis severity measures as compared to placebo over four weeks of therapy. The company also announced that INCB39110 was generally well-tolerated, with no evidence of myelosuppression.
Isis Pharmaceuticals Inc. ( ISIS ) has earned a $2 million milestone payment from Biogen Idec Inc. ( BIIB ), following the first infant in the 12 mg dose group in the phase II study of ISIS-SMNRx in infants with Type I spinal muscular atrophy being dosed.
The study is designed to allow Isis to define the optimal dose for the larger phase 2/3 study in infants and to provide safety and tolerability data. Isis plans to complete this study and initiate the larger phase 2/3 pivotal study early next year.
ISIS closed Thursday's trading at $35.83, down 3.45%.
MyMedicalRecords Inc., a wholly owned subsidiary of MMRGlobal Inc. (MMRF.OB), has filed a complaint against WebMD Health Corp. (WBMD) and WebMD Health Services Group Inc. for infringement of two Personal Health Records patents. MMR is seeking monetary damages as well as a permanent injunction.
Neogen Corp. (NEOG) will be implementing a three-for-two stock split based on the closing sales price per share on Oct. 15, 2013. The stock split will be effected in the form of a stock dividend that will be paid in newly issued common stock on Oct. 30, 2013, to shareholders of record as of the close of business on Oct. 15, 2013, said the company.
NEOG closed Thursday's trading 1% higher at $62.48.
Omeros Corp. (OMER) touched a new high of $13.29 on Thursday before closing at $13.23 following the settlement of an insurance litigation with its insurer, Carolina Casualty Insurance Co. The settlement calls for the insurer to make a payment of $12.5 million to Omeros by October 25, 2013.
Orexigen Therapeutics Inc. (OREX) has submitted the Marketing Authorization Application for Contrave to the European Medicines Agency, seeking approval for the drug for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification.
The company will be resubmitting the Contrave NDA to the FDA by this year end.
OREX rose 5.45% on Thursday to close at $6.39. In after-hours, the stock gained another 0.94% to $6.45.
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