Health indices were flat entering the weekend balanced by regulatory and business news. Neurochem ( NRMX) said Thursday after the close that the Food and Drug Administration acknowledged receipt of its response to a July approvable letter for the company's new-drug application (NDA) for eprodisate for Amyloid A amyloidosis, caused when amyloid proteins are abnormally deposited in organs or tissues. The company said the FDA's goal date to make a decision on the drug is April 2. Shares rose 18 cents, or 6.5%, to $2.96. The stock is a component of the Nasdaq biotechnology index, which was down 7.3, or 0.8%, to 874.29. Amgen ( AMGN - Get Report) lagged $2.27, or 4.2%, to $52.85, after the company announced that it was discussing revising anemia-drug labels with the FDA and that an Oncologic Drugs Advisory Committee would meet to further discuss such drugs. The company said the review and revisions are following recent trial data in breast and cervical cancer. Also down, Discovery Labs ( DSCO) edged down 22 cents, or 7.2%, to $2.82. The company said Friday that it would offer 10 million shares of its common stock at $2.50 a share to raise $25 million. The company expects the offering to close on Dec. 12 subject to the satisfaction of customary closing conditions. Discovery said in an FDA filing that the net proceeds will be about $23.6 million, and it expects to use it to prepare for the commercial launch of Surfaxin for Respiratory Distress Syndrome in premature infants, to pursue potential collaborations and for R&D costs among other things.
In more business news, Edwards Lifesciences ( EW - Get Report) said it will sell its LifeStent line of stents to C.R. Bard Inc. for up to $140 million in an effort to focus on its core businesses. The company will receive a cash payment of $75 million when the deal closes and also $65 million in cash tied to milestones, including regulatory approval of a LifeStent product and the transfer of LifeStent device manufacturing. Edwards also gave 2007 guidance, predicting earnings between $2.08 and $2.12 a share, excluding items, on revenue between $1.07 billion and $1.11 billion. The company expects revenue in a range of $1.16 billion to $1.21 billion in 2008. Analysts polled by Thomson Financial expect $2.09 a share on revenue of $1.08 billion in 2007, and $2.31 a share on revenue of $1.15 billion in 2008. Shares rose 86 cents, or 1.8%, to $48.78. And in earnings, Sirona Dental ( SIRA) earned $51.8 million, or 93 cents a share, in its fourth quarter, compared with a loss of $1.5 million, or 3 cents a share, during the year-ago quarter. Revenue was $177.9 million, vs. $135.5 million in the 2006 period. Analysts polled by Thomson Financial expected 29 cents a share on revenue of $156.3 million. Shares were up $3.66, or 13.32%, to 30.74. Meanwhile dental product company Align Technologies ( ALGN - Get Report) was up $1.51, or 8.6%, to $19.06. Jeffries and Co. analyst Mark Richter upgraded the stock to hold from market perform, forecasting an earnings beat in the fourth quarter.