The top pre-market NASDAQ Stock Market gainers are: MannKind, NVIDIA, Red Robin Gourmet Burgers, Logitech International, and SodaStream International. The top pre-market NASDAQ Stock Market losers are: Sky-mobi, A123 Systems, Golar LNG, Entegris, and Infosys Technologies.
MannKind Corp. (MNKD) stock jumped 24.05 percent to $2.94 in the pre-market trading. The company said it has confirmed with the U.S. Food and Drug Administration the design of two clinical studies that evaluate the efficacy and safety of AFREZZA (insulin human [rDNA origin]), an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation inhaler. The FDA had previously requested that MannKind conduct two clinical trials with the next-generation inhaler (one in patients with type 1 diabetes and one in patients with type 2 diabetes), with at least one trial including a treatment group using the previously studied MedTone inhaler in order to obtain a head-to-head comparison of the pulmonary safety data for the two devices.
Study 171 is an open-label study in patients with type 1 diabetes. After a run-in period, during which all patients will be optimized on their basal insulin regimen, subjects will be randomized to one of three arms: a control arm, in which patients utilize injected rapid-acting insulin at mealtimes, or one of two AFREZZA arms, one each for the MedTone and next-generation device. After the mealtime insulin is titrated, there will be a 12-week observation period on stable doses of the mealtime insulin to assess HbA1c levels, which is the primary outcome parameter. Study 174 will assess AFREZZA using the next-generation inhaler in patients with type 2 diabetes who are inadequately controlled on metformin with or without a second or third oral medication. Patients will be randomized to treatment with AFREZZA or placebo in a randomized fashion. The study will have a titration period, followed by a 12-week observation period to assess HbA1c levels.
NVIDIA Corp. (NVDA) stock advanced 10.51 percent to $14.82 in the pre-market trading. Profit for the second quarter was $151.6 million or $0.25 per share, compared to a loss of $141.0 million or $0.25 per share last year. Adjusted earnings were $193.5 million or $0.32 per share, higher than last year's $47.6 million $0.08 per share. Revenue grew to $1.02 billion from $811.21 million. Analysts had expected profit of $0.25 per share on revenue of $1.01 billion. Looking ahead into the third quarter, the company expects revenue growth of 4 percent to 6 percent from last quarter and gross margin to be flat. The company expects third quarter operating expenses of $361 million to $366 million and adjusted operating expenses of $319 million to $321 million.
Red Robin Gourmet Burgers Inc. (RRGB) stock grew 9.34 percent to $37.01 in the pre-market trading. Profit for the second quarter was $6.9 million or $0.44 per share, up from $4.3 million or $0.28 per share last year. Adjusted earnings were $7.5 million or $0.48 per share, up from $4.5 million or $0.29 per share last year. Revenue grew 7.2 percent to $215.80 million. Analysts had expected profit of $0.36 per share on revenue of $213.04 million. Same-restaurant sales increased 3.1 percent for company-owned restaurants on a 4.5 percent growth in average guest check, partially offset by a 1.4 percent decrease in guest counts.
Logitech International SA (LOGI) stock gained 5.17 percent to $8.75 in the pre-market trading.
SodaStream International Ltd. (SODA) stock increased 4.70 percent to $47.70 in the pre-market trading. Brokerage firm Oppenheimer maintained its "outperform" rating on shares of SodaStream while lowering its price target to $65 from $80. The brokerage has a more conservative view of the company's growth rate after the company reported better-than-expected second quarter results but failed to increase its 2011 revenue outlook.
Sky-mobi Ltd. (MOBI) stock fell 11.70 percent to $4.68 in the pre-market trading. The company lowered its first quarter revenue guidance to range of 164 million Chinese yuan to 167 million Chinese yuan from previous forecast of 180 million Chinese yuan to 190 million Chinese yuan. For the fiscal 2012, the company expects revenue of 680 million Chinese yuan to 690 million Chinese yuan.
"We expect revenues for the quarter to be approximately 10 percent below our original expectations due to our lower than expected overall handset sales in China and a more difficult operating environment for mobile service providers, which has lowered our monetization rate on user activities," said Michael Tao Song, Chief Executive Officer of Sky-mobi. "At the same time, we have seen strong growth for the Maopao Community and expect the growth of the Maopao Community to continue in fiscal 2012 and beyond."
A123 Systems, Inc. (AONE) stock declined 6.52 percent to $4.30 in the pre-market trading. Goldman Sachs downgraded its rating on shares of A123 Systems to "neutral" from "buy" due to lower visibility into the next catalyst that will drive the stock -- the extent of profitability longer term, according to Forbes.
Golar LNG Ltd. (GLNG) stock decreased 1.39 percent to $32.66 in the pre-market trading.
Entegris, Inc. (ENTG) stock declined 1.38 percent to $7.85 in the pre-market trading.
Infosys Technologies Ltd. (INFY) stock moved down 0.73 percent to $53.5866 in the pre-market trading. Shares of companies in India fell sharply Friday as investors were worried that June's unexpectedly high factory output growth reading would increase pressure on the central bank to stick to its monetary tightening. In the Indian market, Infosys stock fell 2.6 percent.