The top pre-market NASDAQ Stock Market gainers are: Icagen, Pacific Biosciences of California, Sangamo Biosciences, Columbia Laboratories, and Sina. The top pre-market NASDAQ Stock Market losers are: Pain Therapeutics, Logitech International, Zalicus, Partner Communications, and Spreadtrum Communications.
Icagen Inc. (ICGN) stock jumped 150.01 percent to $6 in the pre-market trading. In a regulatory filing, Pfizer Inc. (PFE) said it is considering a strategic transaction with Icagen that have the effect of influencing or changing the control of Icagen by means of a stock or asset acquisition or merger. Icagen acknowledged that it is currently engaged in preliminary discussions with Pfizer regarding a potential strategic transaction. No definitive agreement has been reached. There can be no assurance that any agreement will be reached or that a transaction will be consummated. Icagen does not plan to make future announcements with respect to this matter unless and until its Board of Directors has approved a specific transaction or an extension or other modification of the existing collaboration agreement and it has entered into a definitive agreement or the current discussions have terminated.
Pacific Biosciences of California, Inc. (PACB) stock grew 6.01 percent to $12 in the pre-market trading.
Sangamo Biosciences Inc. (SGMO) stock gained 3.82 percent to $6.25 in the pre-market trading.
Columbia Laboratories Inc. (CBRX) stock gained 3.41 percent to $3.34 in the pre-market trading. Watson Pharmaceuticals, Inc. (WPI) said the U.S. FDA has accepted for filing Columbia Laboratories' New Drug Application for PROCHIEVE (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. The acceptance of the NDA for filing means FDA has determined that the application is sufficiently complete to permit a substantive review.
In addition, Columbia has voluntarily withdrawn its request for priority review. Following discussions with FDA, the companies determined that a standard review would afford the agency the appropriate timeframe necessary to complete its review of the application, including empaneling an agency advisory committee, if necessary. Under the Prescription Drug User Fee Act III (PDUFA), the FDA's goal under standard review is to review and act on the NDA by February 26, 2012. Under the terms of the Purchase and Collaboration Agreement between Columbia and Watson, acceptance of the PROCHIEVE NDA will trigger a $5 million milestone payment to Columbia from Watson.
Sina Corp. (SINA) stock increased 3.39 percent to $92.38 in the pre-market trading.
Pain Therapeutics Inc. (PTIE) stock plunged 24.53 percent to $4 in the pre-market trading. The company said the U.S. Food and Drug Administration (FDA) has determined that the new drug application for REMOXY (oxycodone) Extended-Release Capsules CII is not approved. The FDA's Complete Response Letter raised concerns related to, among other matters, the Chemistry, Manufacturing, and Controls section of the NDA for REMOXY. Certain drug lots showed inconsistent release performance during in vitro testing. It is not known at this time whether this is an artifact of the testing method or a manufacturing deficiency.
The company said sufficient information does not yet exist to accurately assess the time required to resolve the concerns raised in the FDA's Complete Response Letter. In the opinion of Pain Therapeutics, potential regulatory approval of REMOXY in the U.S. is unlikely to occur in less than one year, and could be delayed significantly longer than a year. King Pharmaceuticals, Inc. assumed full control of the development of REMOXY in March 2009 and filed a resubmission to the REMOXY NDA on December 23, 2010. Pfizer, Inc. (PFE) obtained rights to REMOXY upon the close of its acquisition of King Pharmaceuticals on February 28, 2011. REMOXY is an investigational extended-release oral formulation of oxycodone for the relief of moderate to severe pain requiring continuous, around-the-clock opioid treatment. It is designed to discourage common methods of tampering. REMOXY was developed by Pain Therapeutics using ORADUR technology licensed from Durect Corp. (DRRX).
Logitech International SA (LOGI) stock decreased 2.06 percent to $10.45 in the pre-market trading.
Zalicus Inc. (ZLCS) stock declined 1.24 percent to $2.39 in the pre-market trading.
Partner Communications Co. Ltd. (PTNR) stock moved down 0.84 percent to $15.10 in the pre-market trading.
Spreadtrum Communications Inc. (SPRD) stock moved down 0.71 percent to $14 in the pre-market trading.