VIVUS, Inc. (NASDAQ:VVUS): Closing price $10.25
On Friday, VIVUS reported it has submitted a request to the European Medicines Agency for scientific advice concerning the use of a pre-specified interim analysis from the AQCLAIM cardiovascular outcomes trial to support the resubmission of the marketing authorization application for approval in Europe of Qsiva for obesity under the centralized procedure. So as to accommodate advice from the European authorities, VIVUS expects that patient enrollment for the AQCLAIM study will begin in the first quarter of 2014.
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA): Closing price $37.72
Teva has announced the launch of the generic equivalent to Niaspan (niacin extended-release) tablets — 500mg, 750mg, and 1000mg in the United States. The company was first to file, making the product eligible for 180 days of marketing exclusivity. Niaspan is marketed by AbbVie and used with diet to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients that have primary hyperlipidemia and mixed dyslipidemia. NIASPAN had accumulated yearly sales of roughly $1.12 billion in the United States, indicated IMS data as of June 30, 2013.
Prosensa Holding NV (NASDAQ:RNA): Closing price $7.14
Prosensa shares closed down 70.25 percent at $7.14 on the day Friday. However, Leerink Swann maintains its Outperform, but slashed its price target from $34 to $11. Analyst Joseph P. Schwartz explains that, “We are lowering our price target on RNA after disappointing drisapersen (Duchenne muscular dystrophy) DEMAND Ph III data were announced this morning. We believe it’s possible, however, that a subgroup covariate pooled analysis could salvage the totality of drisapersen NDA/MAA filings.
“Potential upside for RNA shares from here could come from the promising efficacy signal seen in patients below 7-years old and the fact that pooling DEMAND III data with strong DEMAND II and DEMAND V results could demonstrate that a clinically significant drisapersen treatment benefit is likely. Such analyses were pre-specified and agreed upon beforehand with regulators.”
Response Genetics, Inc. (NASDAQ:RGDX): Closing price $2.28
In Friday, Response Genetics announced that it has reached agreements with institutional investors for the sale of 932,805 shares of its common stock in a registered direct offering at $2.05 per share, which was the closing price on September 19. Gross proceeds of the offering, before deducting the placement agent fee and offering expenses, should come to about $1.9 million. It is expected that the offering will close on or about September 25.
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