The top pre-market NASDAQ Stock Market gainers are: Vermillion, Penson Worldwide, BioSante Pharmaceuticals, Expedia, and Randgold Resources. The top pre-market NASDAQ Stock Market losers are: Nvidia, Yahoo!, BioMimetic Therapeutics, ShoreTel, and Logitech International.
Vermillion, Inc. (VRML) stock climbed 12.35 percent to $6.55 in the pre-market trading. The company said its OVA1 Blood Test was found to be a more accurate detector of Ovarian cancer than the currently recommended CA 125 blood test. The test developed by Vermillion, is offered by Quest Diagnostics Inc. (DGX) in the United States and India. The data from the American College of Obstetrics and Gynecology study was published online ahead of print in the June 2011 edition of its official publication. Quest and Vermillion participated in the study, with neither company having any involvement in the development of the manuscript.
American College of Obstetrics and Gynecology (ACOG) guidelines for the management of ovarian masses recommend the evaluation of factors such as menopausal status and CA 125 blood test levels. Based on the evaluation, patients are divided into low and high risk categories. Treatment plans and surgical referral are planned accordingly. The study compared the CA 125 test and the OVA1 test in 516 women scheduled for surgery for an ovarian mass. Results showed that 94 percent of malignancies were accurately detected by OVA1 compared with 77 percent with CA 125. In premenopausal women, the detection rate was 91 percent versus 58 percent.
Study investigator Rachel Ware Miller, said younger women and early stage cancers were not receiving appropriate surgical staging and treatment, and that an effective preoperative test could have a favorable effect on women's health as survival is better in these populations. OVA1 is the first test cleared by the FDA for aiding in the pre-surgical evaluation of a woman's ovarian mass for cancer, and also is the first protein-based In Vitro Diagnostic Multi-Variate Index Assays (IVDMIA), a new class of software-based diagnostics.
Vermillion performed an estimated 3,080 OVA1 tests during the first quarter of 2011, representing volume growth of 5 percent over the fourth quarter of 2010. For the second quarter, the company expects 3,200 to 3,500 OVA1 tests to be performed.
Penson Worldwide Inc (PNSN) stock jumped 10.58 percent to $3.45 in the pre-market trading. The company said it believes that the recent declines in its stock price appear to be related to its recent Form 10-Q disclosure of a concentrated collateral position associated with Retama Development Corporation related receivables. The company currently expects to resolve this situation without a loss, but even if a loss were realized, Penson said it would have no impact on the company’s solid regulatory capital or sound financial condition.
As reported in the company’s Form 10-Q, as filed with the Securities and Exchange Commission on May 9, Penson has about $42.6 million in non accruing receivables collateralized by securities related to the Retama Development Authority, which have declined in liquidity. The $42.6 million of receivables represent only 0.49 percent of Penson’s $8.7 billion in average daily customer balances during the first quarter of 2011. Penson regularly reviews the value of the collateral, including a recent third party appraisal of the real estate underlying the Retama facility.
The company also announced the resignation of Thomas Johnson from its board of directors. Based on Johnson’s position as chief executive officer of Call Now, Inc, a holder of a portion of the Retama related collateral, both Johnson and Penson Worldwide felt it appropriate for him to resign his position at this time.
BioSante Pharmaceuticals, Inc. (BPAX) stock increased 2.36 percent to $2.60 in the pre-market trading.
Expedia Inc. (EXPE) stock gained 1.91 percent to $25.60 in the pre-market trading.
Randgold Resources Ltd. (GOLD) stock rose 1.54 percent to $77.80 in the pre-market trading.
Nvidia Corp. (NVDA) stock tumbled 6.34 percent to $19.20 in the pre-market trading. Profit for the first quarter was $135.2 million or $0.22 per share, down from $137.6 million or $0.23 per share last year. Adjusted earnings declined to $165.7 million or $0.27 per share from $169 million or $0.29 per share. Revenue fell 4 percent to $962 million. Analysts had expected profit of $0.19 per share on revenue of $946.89 million.
For the second quarter, the company expects revenue to be up 4 percent to 6 percent sequentially, implying revenue of $1.00 billion to $1.02 billion, while Street predicts $991.60 million. The company projects second quarter gross margin to be 50.5 percent to 51.5 percent.
Yahoo! Inc. (YHOO) stock fell 4.95 percent to $16.32 in the pre-market trading. The company said the Alibaba Group, in which it has a 43 percent stake, has transferred its online-payments unit Alipay to a company controlled by the Group's CEO Jack Ma - depriving Yahoo of a valuable asset even as it grapples with intense competition in the search business and looks for newer revenue streams. Yahoo said it and another Alibaba stakeholder, Japan's Softbank Corp., were not aware of Alipay's ownership transfer of last August and the subsequent restructuring.
On March 31, Yahoo! and Softbank were notified by Alibaba Group of two transactions that occurred without the knowledge or approval of the Alibaba Group board of directors or shareholders. The first was the transfer of ownership of Alipay in August 2010. The second was the deconsolidation of Alipay effective in the first quarter of 2011.
Yahoo! disclosed the restructuring in its 10-Q after discussions with Alibaba Group and obtaining a better understanding of this complex situation. Yahoo! further said it continues to work closely with Alibaba and Softbank to protect economic value for all interested parties.
BioMimetic Therapeutics Inc. (BMTI) stock slid 3.80 percent to $8.85 in the pre-market trading. The company said the U.S. Food & Drug Administration’s (FDA) Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted 12-6 in support of the safety of Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures. The panel also voted 10-8 in support of the efficacy of Augment for use as an alternative to autograft in hindfoot and ankle fusions. Additionally, the panel voted 10-8 that Augment demonstrates a favorable benefit to risk profile for the same indication.
The company received unanimous support on all three recommendations from the foot and ankle specialists serving on the panel. The advisory committee’s recommendation will be considered by the FDA when completing its review of Augment Bone Graft’s Premarket Approval (PMA) application. Approval of Augment Bone Graft would mark the company’s entry into the $2.5 billion U.S. bone grafting market. If approved by the FDA, Augment Bone Graft would be the first, new recombinant protein technology for orthopedics introduced to the market in nearly a decade and the first and only cost effective fully synthetic bone growth factor replacement for autograft with Level 1 data supporting its safety and efficacy.
Additionally, the committee’s favorable vote included recommendations regarding potential pre- and post-approval studies. Following the meeting, the company will continue to work closely with the FDA through the next steps of product approval requirements and will ensure the Agency has all information necessary to complete the review process.
ShoreTel, Inc. (SHOR) stock declined 3.34 percent to $11.30 in the pre-market trading.
Logitech International SA (LOGI) stock decreased 1.06 percent to $13.01 in the pre-market trading.