The top pre-market NASDAQ Stock Market gainers are: Amylin Pharmaceuticals, Geron, Alkermes, Intersil, and SodaStream International. The top pre-market NASDAQ Stock Market losers are: Ixia, SemiLEDs, Aixtron, Cree, Virgin Media, ARM Holdings, and Google.
Amylin Pharmaceuticals, Inc. (AMLN) stock grew 8.68 percent to $14.90 in the pre-market trading. The company and Alkermes Inc. (ALKS) announced positive results from a FDA-requested study regarding the new drug application for Bydureon, an investigational medication for type 2 diabetes. Amylin is in partnership with Eli Lilly and Co. (LLY) to develop and market Bydureon (exenatide extended-release for injectable suspension), based on a proprietary technology developed by Alkermes. Bydureon is currently approved in the European Union. Amylin said the results from the thorough QT (tQT) study assessed the potential of exenatide to increase the QT interval across a wide range of plasma concentrations. The study was in accordance with a FDA requirement for the Bydureon New Drug Application.
The QT interval refers to the time the heart's system takes to recharge after each beat. As prolongation of the QT interval may increase the risk for cardiac arrhythmias, the FDA requires a tQT study for most new drugs in development. According to Amylin, the QT study met its primary endpoint, with data showing that exenatide did not prolong the corrected QT (QTc) interval in healthy individuals. Further, the study found no relationship between QTc interval and plasma exenatide concentrations. Amylin, along with Eli Lilly and Alkermes, intends to submit results of the tQT study with the FDA in the third quarter of 2011. Bydureon is an investigational medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. The drug is a once-weekly formulation of exenatide, the active ingredient in Byetta (exenatide) injection available in the U.S. since June 2005 and used in more than 70 countries worldwide to treat type 2 diabetes.
Geron Corp. (GERN) stock grew 6.25 percent to $4.25 in the pre-market trading.
Alkermes Inc. (ALKS) stock increased 4 percent to $20 in the pre-market trading.
Intersil Corp. (ISIL) stock gained 3.99 percent to $13.55 in the pre-market trading.
SodaStream International Ltd. (SODA) stock rose 3.66 percent to $74.50 in the pre-market trading.
Ixia (XXIA) stock plunged 20.06 percent to $10.40 in the pre-market trading. The company lowered its second quarter adjusted earnings guidance to range of $0.07 to $0.08 per share from previous forecast of $0.14 to $0.17 per share. The company also reduced revenue outlook to range of $67 million to $69 million from previous range of $78 million to $82 million. Street analysts predict profit of $0.16 per share on revenue of $80.54 million. The company said its second quarter revenue was impacted by several factors, including lower than expected revenue from Asia Pacific and from certain large equipment makers, as well as orders received late in the quarter that could not be fulfilled in the second quarter.
SemiLEDs Corp. (LEDS) stock plummeted 15.16 percent to $5.26 in the pre-market trading. Adjusted loss for the third quarter was $4.3 million or $0.16 per share, compared to a profit of $3.3 million to $0.09 per share last year. Revenue fell 43 percent to $5.6 million. Analysts had expected a loss of $0.06 per share on revenue of $6.25 million. Looking ahead, the company expects fourth quarter loss of $0.23 to $0.25 per share and revenue of $5.5 million to $6.5 million, while Street predicts a loss of $0.02 per share on revenue of $9.02 million.
Aixtron SE (AIXG) stock slid 4.31 percent to $30.64 in the pre-market trading.
Cree Inc. (CREE) stock tumbled 2.33 percent to $32.70 in the pre-market trading.
Virgin Media, Inc. (VMED) stock declined 2.06 percent to $29.52 in the pre-market trading.
ARM Holdings plc (ARMH) stock decreased 1.57 percent to $30.01 in the pre-market trading.
Google Inc. (GOOG) stock moved down 1.21 percent to $539.98 in the pre-market trading.