The top pre-market NASDAQ Stock Market gainers are: SunOpta, EnerNOC, Identive Group, Ness Technologies, BioSante Pharmaceuticals, and Vical. The top pre-market NASDAQ Stock Market losers are: Amedisys, United Therapeutics, Yongye International, Star Scientific, and Corinthian Colleges.
SunOpta Inc. (STKL) stock jumped 16.22 percent to $8.60 in the pre-market trading.
EnerNOC, Inc. (ENOC) stock grew 9.50 percent to $17.75 in the pre-market trading. The company said its strong support for the Order issued by the Federal Energy Regulatory Commission (FERC) on June 3 regarding the methodology for valuing demand response resources in PJM's capacity market. In its Order, FERC ruled that PJM's proposed tariff changes have not been shown to be just and reasonable and may be unjust, unreasonable, unduly discriminatory or preferential or otherwise unlawful. Accordingly, FERC suspended PJM's filing for the maximum allowable period provided by law and, in doing so, affirmed existing market rules through the full compliance period of the 2011/2012 delivery year.
Identive Group, Inc. (INVE) stock gained 7.69 percent to $2.38 in the pre-market trading. Cowen initiated coverage of Identive Group with an outperform rating. In addition, the company's business unit SCM Microsystems announced its SCM3712 commercial NFC reader module, a compact add-on that enables NFC (Near Field Communication) peer-to-peer functionality for a wide range of devices and equipment, from handheld card readers to POS terminals to vending machines.
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The reader can be plugged into an existing commercial device to make it NFC ready and enable contactless, secure data exchange for applications such as cashless payments, ticketing, electronic ID and loyalty couponing. The SCM3712 NFC reader module is available now to OEMs and systems integrators.
SCM Microsystems said the SCM3712 NFC module has a small footprint, connects via a USB interface and is available with either an integrated antenna or an optional external antenna. It offers ISO 14443, FeliCa, NFC peer-to-peer functionality and is fully capable of handling NFC Forum-compliant tags based on MIFARE, FeliCa and Topaz technology as well as NFC-enabled mobile phones or other devices.
Ness Technologies Inc. (NSTC) stock gained 4.85 percent to $6.27 in the pre-market trading.
BioSante Pharmaceuticals, Inc. (BPAX) stock increased 3.99 percent to $3.13 in the pre-market trading. The company said the FDA's clinical hold on the GVAX Prostate Cancer Vaccine, or GVAX Prostate, for the treatment of prostate cancer has been lifted by FDA. Manufacturing of new GVAX Prostate is complete and added that planning for a Phase II clinical trial at the Johns Hopkins Kimmel Cancer Center is underway. The manufacturing of GVAX Prostate was funded by BioSante. The trial will be supported in part by the Prostate Cancer Foundation. Important start-up funding for the study was provided by the OneInSix Foundation.
According to BioSante, unlike the recently approved Provenge for the treatment of prostate cancer, which requires isolation of cells from the patient that are then modified to produce the vaccine which is then re-introduced into the patient, GVAX Prostate is an off-the-shelf, non-patient-specific vaccine. It is comprised of prostate cancer cells that have been modified to secrete GM-CSF, an immune stimulatory cytokine, and then irradiated for safety. The company said GVAX Prostate will be administered via intradermal injections on an outpatient basis.
Vical Inc. (VICL) stock rose 3.37 percent to $3.99 in the pre-market trading. The company announced results from new statistical analyses of data from three previously completed clinical trials of the company's Allovectin immunotherapy in patients with metastatic melanoma, showing with strong positive correlation that responders lived significantly longer than nonresponders. In a Phase 2 study of high-dose (2 mg) Allovectin in 127 chemo-refractory or chemo-intolerant patients with metastatic melanoma, the overall survival was 65 percent at one year, 43 percent at two years, and 32 percent at three years. The median overall survival was 18.8 months.
Survival among the 15 clinical responders ranged from 18 months to more than seven years (median survival not reached; 95 percent CI: 35.5 months -- not reached). The median overall survival for nonresponders in the Phase 2 study was 16.2 months (95 percent CI: 13.3 -- 21.2 months), which is notably longer than historical survival for other metastatic melanoma treatments, suggesting that these patients also may have derived clinical benefit from Allovectin.
Allovectin is a systemic immunotherapeutic with a unique mechanism of action that may be complementary to currently approved treatments. It is delivered into a single tumor lesion, but elicits an immune response directed against lesions throughout the body.
Amedisys Inc. (AMED) stock tumbled 7.41 percent to $27.98 in the pre-market trading.
United Therapeutics Corp. (UTHR) stock fell 6.30 percent to $58.75 in the pre-market trading. The company said its preliminary analysis of FREEDOM-M Phase 3 trial of treprostinil diethanolamine, an investigational sustained release oral formulation of treprostinil in patients with pulmonary arterial hypertension has met its primary endpoint. Treprostinil is a stable synthetic form of prostacyclin indicated for the treatment of pulmonary arterial hypertension to improve exercise ability. The primary efficacy endpoint of the trial was the change in six-minute walk distance at 12 weeks for the 228 patients.
FREEDOM-M was a randomized, double-blind, placebo-controlled trial of patients with pulmonary arterial hypertension, a chronic, life-threatening illness. The study enrolled 349 patients who were not receiving any approved pulmonary arterial hypertension medication, with the population for the primary analysis consisting of the 228 patients who had access to the 0.25 mg tablet at randomization. The company added that 313-patient FREEDOM-C(2) trial is studying oral treprostinil in pulmonary arterial hypertension patients who are receiving an endothelin receptor antagonist and/or a PDE-5 inhibitor. Preliminary analysis of the results of the trial are expected to be announced in September.
Yongye International, Inc. (YONG) stock slid 5.43 percent to $4.70 in the pre-market trading. The company is subject of a securities fraud class action lawsuit, the Rosen Law Firm P.A. said. The complaint alleges that Yongye's financial results were inconsistent with the company's ability to produce the tonnage reported as shipments of sales. The complaint further alleges that Yongye's reported financial statements were grossly inflated by including revenue it had not earned. The lawsuit was filed on behalf of investors who purchased the common stock of Yongye during the period from August 11, 2010 through May 18, 2011, inclusive. The suit is seeking to recover investors' damages from violations of federal securities laws.
Star Scientific, Inc. (CIGX) stock declined 3.46 percent to $4.46 in the pre-market trading.
Corinthian Colleges Inc. (COCO) stock decreased 2.97 percent to $4.90 in the pre-market trading.