Morning Movers 8/3: KERX, TSPT, TSEM, ICAD, AMFI Higher; HURN, RPRX, ADAT, SVNT Lower
Up)
Huron Consulting (Nasdaq: HURN) 72.9% LOWER; late Friday announced a financial restatement and news that its CEO and CFO will be leaving the company. Following this news, we have analysts at Deutsche Bank, Baird, SunTrust and Oppenheimer out downgrading the stock.
Repros Therapeutics (Nasdaq: RPRX) 58.5% LOWER; announced that, in the interest of patient safety, it is voluntarily suspending dosing of all patients in its clinical trials of Proellex. This decision is based on available information regarding the occurrence of clinically significant increases in liver enzymes with 50 mg and 25 mg doses of Proellex, coupled with recent input from a consulting panel of liver experts. The Company submitted a meeting request to the Food and Drug Administration (FDA) on July 30, 2009 and in response, FDA has proposed to change the topic of the previously scheduled End of Phase II meeting for endometriosis in late September into a discussion about the safety of Proellex and overall direction and scope of the program.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) 44.4% HIGHER; announced today that it has reached agreement with the U.S. FDA regarding a Special Protocol Assessment on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in relapsed or relapsed / refractory multiple myeloma patients previously treated with bortezomib (VELCADE((R))). Click here for the full report.
Authentidate Holding Corp. (Nasdaq: ADAT) 34.7% LOWER; today announced that Medical Services of America, Inc., a leading provider of home healthcare services and medical equipment, headquartered in Lexington South Carolina, will implement Authentidate's Inscrybe(TM) Healthcare web-based service to streamline completion of healthcare referral orders and other healthcare documentation by physicians. Here is the full report.
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) 34% HIGHER; Purdue Pharmaceutical Products L.P. and Transcept today announced entry into an exclusive license and collaboration agreement to commercialize Intermezzo((R)) (zolpidem tartrate sublingual tablet) in the United States. If approved by the U.S. FDA), Intermezzo((R)) has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Click here to see the full report.
Tower Semiconductor, Ltd. (Nasdaq: TSEM) 30.5% HIGHER; Medigus Ltd. and Tower Semi today announced successful sampling of a new CMOS imager that will serve in Medigus' line of disposable miniature cameras and its new medical devices camera; the smallest of its kind in the world, designated to be incorporated into disposable endoscopes or used in various diagnostic and surgical medical applications. First product samples have been shipped to end customers and mass production of the camera is expected to commence in mid-2010. The camera sensor will be manufactured in Tower's Fab2 using its 0.18-micron CMOS image sensor process and will be integrated into the camera which will be produced in Medigus' manufacturing facilities. Here is the full report.
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) 30.9% LOWER; is under pressure this morning, down over 30%, after the company announced it has received a complete response letter from the FDA stating that the FDA can not at this time approve the Company's Biologics License Application for KRYSTEXXA as a treatment for chronic gout in patients refractory to conventional therapy. Click here for the full report.
iCAD, Inc. (Nasdaq: ICAD) 25% HIGHER; today announced the completion of a six-system sale to the Osakidetza Regional Health Care Service in the Basque region of Spain. Here is the full report.
AMCORE Financial, Inc. (Nasdaq: AMFI) 16.6% HIGHER; today announced it received a waiver from its lender, JP Morgan Chase, with respect to the previously disclosed technical default under its credit facility. AMCORE is current with all its payments due under that facility and on July 31st paid down the $20 million loan by $7.5 million. Additionally, the maturity of the remaining $12.5 million was extended to April 2011.
MDRNA, Inc. (NASDAQ: MRNA) 15.3% HIGHER; announced positive data on its proprietary UsiRNA technology, demonstrating that its UsiRNAs are highly potent against metabolic disease and cancer targets in rodent models. Further, the data establish that the knockdown of these targets is achieved via an RNAi-mediated process. Of particular importance is that the data demonstrate that strategic placement of UNA (unlocked nucleobase analogs) results in the ability to manipulate, either increasing or decreasing, strand-specific activity thus minimizing off-target activity and providing the ability to impart improved drug-like characteristics to the UsiRNAs. The data are being presented today by Michael V. Templin, Ph.D., Vice President, Discovery Research and Pharmaceutical Development of MDRNA, at the IBC Drug Discovery & Development Week, Oligonucleotide Therapeutics: From Concept to Implementation, in Boston, Massachusetts.
American Axle (NYSE: AXL) 13.6% HIGHER; the entire auto group is moving higher today on reports that Ford (NYSE: F) is expected to post the first monthly sales increase in more than 2 years later today.
Oncothyreon Inc. (Nasdaq: ONTY) 12.1% HIGHER; today announced that clinical data relating to long-term treatment with Stimuvax were presented at the International Association for the Study of Lung Cancer's 13th World Conference on Lung Cancer in San Francisco on August 1, 2009. The presentation by Dr. Glenwood Goss from the Ottawa Hospital Cancer Centre, Ottawa, Ontario, involved 16 patients who received treatment with Stimuvax for between 2 and 8.2 years as part of the Phase 2b trial in patients with stage IIIb/IV non-small cell lung cancer. Click here for the full report.
Orbitz (NYSE: OWW) 11.5% HIGHER; Benchmark upgrades the stock from Hold to Buy and price target from $2 to $4. Click here to see more color on the upgrade.
To get this report daily, visit http://www.streetinsider.com/entities/Morning+Movers.
Repros Therapeutics (Nasdaq: RPRX) 58.5% LOWER; announced that, in the interest of patient safety, it is voluntarily suspending dosing of all patients in its clinical trials of Proellex. This decision is based on available information regarding the occurrence of clinically significant increases in liver enzymes with 50 mg and 25 mg doses of Proellex, coupled with recent input from a consulting panel of liver experts. The Company submitted a meeting request to the Food and Drug Administration (FDA) on July 30, 2009 and in response, FDA has proposed to change the topic of the previously scheduled End of Phase II meeting for endometriosis in late September into a discussion about the safety of Proellex and overall direction and scope of the program.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) 44.4% HIGHER; announced today that it has reached agreement with the U.S. FDA regarding a Special Protocol Assessment on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in relapsed or relapsed / refractory multiple myeloma patients previously treated with bortezomib (VELCADE((R))). Click here for the full report.
Authentidate Holding Corp. (Nasdaq: ADAT) 34.7% LOWER; today announced that Medical Services of America, Inc., a leading provider of home healthcare services and medical equipment, headquartered in Lexington South Carolina, will implement Authentidate's Inscrybe(TM) Healthcare web-based service to streamline completion of healthcare referral orders and other healthcare documentation by physicians. Here is the full report.
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) 34% HIGHER; Purdue Pharmaceutical Products L.P. and Transcept today announced entry into an exclusive license and collaboration agreement to commercialize Intermezzo((R)) (zolpidem tartrate sublingual tablet) in the United States. If approved by the U.S. FDA), Intermezzo((R)) has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Click here to see the full report.
Tower Semiconductor, Ltd. (Nasdaq: TSEM) 30.5% HIGHER; Medigus Ltd. and Tower Semi today announced successful sampling of a new CMOS imager that will serve in Medigus' line of disposable miniature cameras and its new medical devices camera; the smallest of its kind in the world, designated to be incorporated into disposable endoscopes or used in various diagnostic and surgical medical applications. First product samples have been shipped to end customers and mass production of the camera is expected to commence in mid-2010. The camera sensor will be manufactured in Tower's Fab2 using its 0.18-micron CMOS image sensor process and will be integrated into the camera which will be produced in Medigus' manufacturing facilities. Here is the full report.
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) 30.9% LOWER; is under pressure this morning, down over 30%, after the company announced it has received a complete response letter from the FDA stating that the FDA can not at this time approve the Company's Biologics License Application for KRYSTEXXA as a treatment for chronic gout in patients refractory to conventional therapy. Click here for the full report.
iCAD, Inc. (Nasdaq: ICAD) 25% HIGHER; today announced the completion of a six-system sale to the Osakidetza Regional Health Care Service in the Basque region of Spain. Here is the full report.
AMCORE Financial, Inc. (Nasdaq: AMFI) 16.6% HIGHER; today announced it received a waiver from its lender, JP Morgan Chase, with respect to the previously disclosed technical default under its credit facility. AMCORE is current with all its payments due under that facility and on July 31st paid down the $20 million loan by $7.5 million. Additionally, the maturity of the remaining $12.5 million was extended to April 2011.
MDRNA, Inc. (NASDAQ: MRNA) 15.3% HIGHER; announced positive data on its proprietary UsiRNA technology, demonstrating that its UsiRNAs are highly potent against metabolic disease and cancer targets in rodent models. Further, the data establish that the knockdown of these targets is achieved via an RNAi-mediated process. Of particular importance is that the data demonstrate that strategic placement of UNA (unlocked nucleobase analogs) results in the ability to manipulate, either increasing or decreasing, strand-specific activity thus minimizing off-target activity and providing the ability to impart improved drug-like characteristics to the UsiRNAs. The data are being presented today by Michael V. Templin, Ph.D., Vice President, Discovery Research and Pharmaceutical Development of MDRNA, at the IBC Drug Discovery & Development Week, Oligonucleotide Therapeutics: From Concept to Implementation, in Boston, Massachusetts.
American Axle (NYSE: AXL) 13.6% HIGHER; the entire auto group is moving higher today on reports that Ford (NYSE: F) is expected to post the first monthly sales increase in more than 2 years later today.
Oncothyreon Inc. (Nasdaq: ONTY) 12.1% HIGHER; today announced that clinical data relating to long-term treatment with Stimuvax were presented at the International Association for the Study of Lung Cancer's 13th World Conference on Lung Cancer in San Francisco on August 1, 2009. The presentation by Dr. Glenwood Goss from the Ottawa Hospital Cancer Centre, Ottawa, Ontario, involved 16 patients who received treatment with Stimuvax for between 2 and 8.2 years as part of the Phase 2b trial in patients with stage IIIb/IV non-small cell lung cancer. Click here for the full report.
Orbitz (NYSE: OWW) 11.5% HIGHER; Benchmark upgrades the stock from Hold to Buy and price target from $2 to $4. Click here to see more color on the upgrade.
To get this report daily, visit http://www.streetinsider.com/entities/Morning+Movers.
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