Genentech (DNA) shares drop after the FDA panel voted 5-4 against approving Avastin for patients with breast cancer that has spread to other parts of the body. The panel said the drug's benefit in slowing tumor growth isn't worth the added risk of serious side effects, including high blood pressure and death. Avastin was approved by the FDA in 2004 for colorectal cancer and in 2006 for lung cancer.
MBIA (MBI) shares drop 12% after Moody's released a report saying: "with regard to MBIA, additional analysis of its direct RMBS portfolio leads Moody's to believe the guarantor is at greater risk of exhibiting a capital shortfall than previously communicated; we now consider this somewhat likely."
American International Group (AIG) rises after the insurance company said it has very little exposure to structured investment vehicles.
Comcast (CMCSA) warns that it expects to fall short of its guidance for several key financial metrics for the year, citing "an increasingly challenging economic and competitive environment." It now sees 2007 free cash flow falling 20%. It now expects revenue generating units (RGUs) to increase by about 6 million to 57 million in 2007, vs. previous guidance of about 6.5 million additions. S&P cuts target, maintains sell. Goldman downgrades to neutral to buy.
Collective Brands (PSS) posts better-than-expected $0.39 third quarter EPS, vs. $0.43 a year ago, on 3.5% lower same-store sales (which include only Payless results), 18% total sales rise.
Guess? (GES) posts $0.62 third quarter EPS, vs. $0.48 a year ago, on 43% revenue rise. It raises fiscal year 2008 EPS guidance to $1.93-$1.96. It sees $2.35-$2.45 fiscal year 2009 EPS.
Chico's FAS (CHS) posts $0.13 third quarter EPS, vs. $0.24 a year ago, on 9.3% same-store sales drop, 3.4% total sales rise. It says fourth quarter EPS could approach breakeven. S&P keeps hold.
Photronics (PLAB) posts $0.01 fourth quarter EPS, vs. $0.21 a year ago, on 12% revenue drop.
DSW (DSW) posts $0.51 third quarter EPS, vs. $0.36 a year ago, on 3% lower same-store sales, 11% higher total sales. Based on the performance through third quarter, it sees $1.24-$1.29 fiscal year 2008 EPS, same-store sales of flat to down 1% vs. previous forecast of flat to down 2%.
Electronic Data Systems (EDS) sets $1 billion share buyback. S&P says it does not think the buyback will have a notable positive impact on the shares in coming quarters, reiterates sell.
Western Digital (WDC) says in an 8-K that demand has remained strong, pricing has remained rational in the second quarter to date in all hard drive market categories, in all geographies. It notes industry inventories are at significantly lower levels than at same time last year. As a result of these conditions, it expects second quarter revenue of $2.025-$2.075 billion, EPS of $1.02-$1.06. S&P raises fiscal year 2008 EPS estimate, target, keeps buy.
Famous Dave's of America (DAVE) says its president and chief executive officer, David Goronkin, will resign, effective Dec. 13, to pursue other interests. F. Lane Cardwell Jr., a member of the board, has been named as acting CEO while DAVE undertakes a search for Mr. Goronkin's permanent replacement.
Panera Bread (PNRA) posts 3.2% higher November system-wide comparable bakery-cafe sales.
Sohu.com (SOHU) raises fourth quarter total revenue guidance to $55.5-$57.5 million, an increase of $2 million over previous guidance. It now sees non-GAAP fourth quarter EPS of $0.36-$0.38, an increase of $0.03.
Commscope (CTV) says due to positive trends in sales, orders and operations, it now sees $435-$445 million fourth quarter revenue, operating income to increase by 30%-45% year-over-year, based on expected operating margin of 11.5%-12.5%. It notes previous fourth quarter guidance was sales of $420-$440 million, operating margin of 11.0%-12.0%, excluding special items.
Adolor (ADLR) and Pfizer (PFE) announce exclusive worldwide collaboration to develop and commercialize novel compounds, ADL5859 and ADL5747, for the treatment of pain. Both compounds are proprietary Delta opioid receptor agonist candidates with the potential to treat a wide range of inflammatory, neuropathic and acute pain conditions.