The top pre-market NASDAQ stock market gainers are: Idenix Pharmaceuticals, Achillion Pharmaceuticals, VIVUS, MAKO Surgical, Questcor Pharmaceuticals, Research In Motion and Apple. The top pre-market NASDAQ stock market losers are: IPC The Hospitalist Company, Pacira Pharmaceuticals, Akamai Technologies, Logitech International and Costco Wholesale.
Idenix Pharmaceuticals Inc. (IDIX) stock jumped 39.43 percent to $9.83 in pre-market trading. The company announced the advancement of its hepatitis C virus, or HCV, development pipeline. The company announced the initiation of a phase I clinical trial of its NS5A inhibitor, IDX719. Idenix said the first part of the study will assess safety, pharmacokinetics and food effect of IDX719 in 48 healthy volunteers. A subsequent part of the study will evaluate three days of IDX719 treatment in treatment-naive genotype 1 HCV-infected patients and is expected to begin in the second quarter of 2012. Preclinical studies demonstrated that IDX719 has potent, pan-genotypic activity in vitro with the potential for once-daily dosing. Further, Idenix said it has selected two additional nucleotide inhibitors, IDX19368 and IDX19370, as potential clinical candidates. The company anticipates Investigational New Drug filings in mid-2012.
Achillion Pharmaceuticals Inc. (ACHN) stock climbed 27.65 percent to $10.11 in pre-market trading. The company announced new clinical trial results on its portfolio of protease inhibitors, including Phase 2 interim 12-week treatment results with ACH-1625 for the treatment of genotype 1 treatment-naive hepatitis C virus or HCV, exploratory data on ACH-1625 for HCV genotype 3 treatment and initial proof-of-concept data for ACH-2684. Achillion said it further intends to explore ACH-1625 in combination with other oral antiviral agents for treating all HCV genotypes and continues to evaluate ACH-2684 in a Phase 1 clinical trial. In the second segment of this ongoing Phase 2a trial, three doses of once-daily ACH-1625 in combination with pegylated interferon alfa-2a and ribavirin (P/R) were dosed over 12 weeks of therapy in patients with treatment-naive HCV genotype 1.
For 2012, Achillion plans to conduct a number of trials to further characterize its portfolio of protease inhibitors, including ACH-1625 and ACH-2684 and its NS5A inhibitors, including ACH-2928 and ACH-3102. Further to the ongoing Phase 1 trials with ACH-2684 and ACH-2928, the company intends to submit an Investigational New Drug or IND application and begin a Phase 1 clinical trial with ACH-3102 during the second quarter of 2012. During the 2012 second half, Achillion plans to initiate an all-oral interferon-free combination study which would evaluate a protease inhibitor and a NS5A inhibitor, with or without ribavirin, for the treatment of HCV.
VIVUS Inc. (VVUS) stock grew 18.11 percent to $12 in pre-market trading. The company said that following recent discussions with Food and Drug Administration (FDA) officials, the company has been asked to remove the Qnexa contraindication for women of childbearing potential contained in the proposed label. Qnexa would remain contraindicated for women who are pregnant. A contraindication typically indicates that a drug should not be used because the risk of use clearly outweighs any possible therapeutic benefit. Included with the resubmission of the Qnexa New Drug Application (NDA) was a proposed Risk Evaluation and Mitigation Strategy, or REMS. The company is currently revising its proposed REMS based on this change in the contraindication and plans to discuss the details of the Qnexa REMS during the upcoming Endocrinologic and Metabolic Drugs Advisory Committee. The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Qnexa NDA on Feb. 22. The target date for the FDA to complete its review of the Qnexa NDA is April 17.
MAKO Surgical Corp. (MAKO) stock grew 11.71 percent to $32.15 in pre-market trading. The company reported selling 18 of its RIO surgical platform systems in fourth-quarter 2011, compared to 13 systems sold in fourth-quarter 2010. The company added that 2258 MAKOplasty procedures were performed in the recent quarter, with 2167 performed at domestic sites. In the prior-year period, MAKOplasty procedures totaled 1146 of which procedures at domestic sites came to 1142. Looking ahead, the company anticipates selling 56 to 62 RIO systems in 2012, and further expects that 11,000 to 13,000 MAKOplasty procedures may be performed.
Questcor Pharmaceuticals, Inc. (QCOR) stock gained 8.60 percent to $42.30 in pre-market trading.
Research In Motion Ltd. (RIMM) stock increased 1.69 percent to $15.60 in pre-market trading. The company will showcase the new BlackBerry 7.1 OS as well as updates to the BBM (BlackBerry Messenger), BlackBerry Traffic and BlackBerry Travel apps at this year's Consumer Electronics Show (CES 2012). BlackBerry 7.1 will begin rolling out from carriers around the world beginning today and over the coming weeks. In addition, the company will preview new features of BlackBerry PlayBook OS 2.0 that will enable customers to stay even more connected and productive in their personal and professional lives.
Apple Inc. (AAPL) stock moved up 0.74 percent to $425.51 in pre-market trading. According to the Business Insider, Goldman Sachs raised its estimates for Apple's holiday quarter.
IPC The Hospitalist Company, Inc. (IPCM) stock plunged 21.10 percent to $36.02 in pre-market trading. The company said it expects fourth quarter earnings of $0.47 to $0.51 per share and revenue of $115 million to $118 million, while Street predicts profit of $0.54 per share on revenue of $124.43 million. For the full year 2011, the company lowered its earnings guidance to range of $1.70 to $1.74 per share from previous forecast of $1.78 to $1.86 per share. The company also reduced its 2011 revenue outlook to range of $455 million to $458 million from previous range of $463 million to $465 million. Street analysts predict profit of $1.77 per share on revenue of $464.13 million for the full year 2011.
Pacira Pharmaceuticals Inc. (PCRX) stock fell 5.88 percent to $8 in pre-market trading. The company provided updated timing for its commercial launch of EXPAREL (bupivacaine liposome injectable suspension), a non-opioid analgesic that was approved by the U.S. Food and Drug Administration (FDA) for administration into the surgical site to produce postsurgical analgesia. Since FDA approval of EXPAREL in October 2011, Pacira has continued to execute its pre-commercial launch strategy focused on the broad hospital market and has undertaken initiatives to expand and enhance its ability to efficiently manufacture commercial quantities of EXPAREL. As planned, Pacira has hired and trained a sales force and will proceed with a formulary-access driven launch strategy, beginning with a national sales meeting this week. Due to commercial manufacturing challenges, which Pacira is confident it can address, the company projects product availability in April 2012, by which time Pacira expects it will have manufactured sufficient product to meet customer demands at launch.
Akamai Technologies, Inc. (AKAM) stock declined 2.63 percent to $31.90 in pre-market trading. Brokerage firm Citigroup downgraded its rating on shares of Akamai to sell from neutral citing valuation and greater competition from Amazon.com (AMZN), according to theflyonthewall.com.
Logitech International SA (LOGI) stock decreased 1.80 percent to $7.65 in pre-market trading.
Costco Wholesale Corp. (COST) stock declined 1.26 percent to $80.11 in pre-market trading.