The Nasdaq Composite stock market index is seen inside its studios at Times Square in New York in this file image
The Nasdaq Composite stock market index is seen inside its studios at Times Square in New York in this file image from April 1, 2011. Reuters

The top pre-market NASDAQ stock market gainers are: Affymax, G-III Apparel Group, Central European Distribution, BioSante Pharmaceuticals, and Amgen. The top pre-market NASDAQ stock market losers are: Tesla Motors, Clearwire, Aixtron, ASM International, and Crosstex Energy.

Gainers

Affymax, Inc. (AFFY) stock jumped 22.74 percent to $7.19 in pre-market trading. The company and Takeda Pharmaceutical Co. Ltd. said that the U.S. FDA Oncologic Drugs Advisory Committee voted in favor of benefit/risk profile for Peginesatide for treatment of anemia in chronic kidney disease patients on dialysis. Peginesatide, formerly known as Hematide, is a synthetic peptide-based erythropoiesis stimulating agent, or ESA, designed to stimulate production of red blood cells. FDA voted 15 to 1, with 1 abstention, and FDA is not bound by recommendations of its advisory committees, their guidance will be considered by the FDA in its review of NDA that was submitted for peginesatide in May 2011. The scheduled Prescription Drug User Fee Act date for peginesatide is March 27, 2012. Affymax and Takeda will continue efforts to make this alternative available to dialysis patients and the providers who treat them.

G-III Apparel Group, Ltd. (GIII) stock climbed 17.83 percent to $23.99 in pre-market trading. Profit for the third quarter was $43.6 million or $2.16 per share, compared to $42.7 million or $2.16 per share last year. Sales grew to $510 million from $450 million. Analysts had expected profit of $2.14 per share on revenue of $497.49 million. Looking ahead into the fiscal 2012, the company lowered its earnings guidance to the range of $2.50 to $2.60 per share from previous forecast of $3.05 to $3.15 per share. The company still expects 2012 sales of about $1.25 billion. Street analysts predict profit of $2.80 per share on revenue of $1.24 billion for the fiscal 2012.

Separately, G-III Apparel said it has entered into a retail store agreement with Calvin Klein Inc., a subsidiary of PVH Corp. (PVH), to open Calvin Klein Performance stores and shop in shops for the sale of women's Calvin Klein Performance apparel in the United States and China. G-III also has rights to expand to additional countries throughout the world. Terms of the deal were not disclosed.

Central European Distribution Corp. (CEDC) stock grew 7.63 percent to $5.50 in pre-market trading.

BioSante Pharmaceuticals, Inc. (BPAX) stock gained 4.08 percent to $2.55 in pre-market trading.

Amgen Inc. (AMGN) stock increased 2.33 percent to $59.70 in pre-market trading. The company announced the preliminary results of its modified Dutch auction tender offer, which expired on Wednesday. Based on the preliminary count by American Stock Transfer & Trust Company, LLC, the depositary for the tender offer, a total of 98.06 million shares of Amgen's common stock were properly tendered and not properly withdrawn at or below the purchase price of $60.00 per share, including 30.83 million shares that were tendered through notice of guaranteed delivery. Amgen has been informed by the depositary that the preliminary proration factor for the tender offer is about 85 percent. In accordance with the terms and conditions of the tender offer, and based on the preliminary count by the depositary, Amgen expects to acquire about 83.3 million shares of its common stock at a price of $60.00 per share, for an aggregate cost of about $5 billion, excluding fees and expenses relating to the tender offer. These shares represent about 9.5 percent of the shares outstanding.

Losers

Tesla Motors, Inc. (TSLA) stock fell 7.87 percent to $31.50 in pre-market trading.

Clearwire Corp. (CLWR) stock fell 7.46 percent to $2.11 in pre-market trading. The company said its previously announced public offering of its Class A Common Stock has been upsized from $300.0 million to $350.0 million. Clearwire priced its 175 million shares of the public offering at $2.00 per share. Clearwire has also granted the underwriters a 30-day option to purchase up to an additional $52.5 million, or 26.25 million shares, of its Class A Common Stock. The offering is expected to close on Dec. 13.

In addition, Sprint Nextel Corp. (S) agreed to exercise its pro rata preemptive rights with respect to the offering in the Commitment Agreement between Clearwire and Sprint, dated Nov. 30. Upon such exercise, Sprint will purchase, in a separate, private transaction, about 172 million additional shares of Clearwire's Class B Common Stock and a corresponding number of Class B Common Interests in Clearwire's subsidiary, Clearwire Communications, LLC. Clearwire said it intends to use the net proceeds for general corporate and working capital purposes, including the deployment of mobile 4G LTE technology alongside the mobile 4G WiMAX technology currently on its network and for the operation and maintenance of its networks and to pay fees and expenses associated with this offering.

Aixtron SE (AIXG) stock declined 3.58 percent to $12.12 in pre-market trading.

ASM International NV (ASMI) stock decreased 3.55 percent to $28.29 in pre-market trading.

Crosstex Energy LP (XTEX) stock declined 3.23 percent to $15.30 in pre-market trading.