Monday's Health Winners & Losers

Stock quotes in this article: AMLN , STXS , LGND , GSK , ARTC , ARRY , PFE  

Health indices followed the broader market modestly lower Monday, with clinical data, profit reports and analyst actions moving stocks.

Amylin Pharmaceuticals(AMLN Quote) gave up 6% on concerns that the Food and Drug Administration's new proposed guidelines for type II diabetes drugs could affect the late stage trials for exenatide LAR, a weekly version of the company's Byetta. The FDA's guidelines involve potentially seeking more safety and efficacy data,

Lazard analyst Matt Osborne downgraded Amylin's stock to hold from buy. "We are moving to the sidelines pending further evidence that safety does not appear to be a concern for exenatide LAR, and that timelines for submission (2Q09) will not shift in some way as a result of this draft guidance," he wrote in a report. Shares fell $1.64 to $24.83.

The stock contributed to a decline on the Nasdaq biotechnology index, which was down 3.52, or 0.45%, to 780.86.

Elsewhere, Stereotaxis(STXS Quote) plunged 32% after the cardiology-product company reported that its fourth-quarter loss doubled, worse than expectations. The company posted a loss of $12.2 million, or 36 cents a share, widened from $6.1 million, or 18 cents a share in the year-ago quarter. Revenue for the quarter fell to $10.3 million from $14 million, due to a delay in the European and FDA approvals for its magnetic irrigated catheter.

Analysts surveyed by Thomson Financial expected a loss of 31 cents a share on revenue of $10.3 million. Shares of Stereotaxis tumbled $1.84 to $3.94.

Among stocks in the green, an FDA update helped Ligand(LGND Quote) and GlaxoSmithKline(GSK Quote) on Monday. The companies said the FDA accepted their new drug application for Promacta for idiopathic thrombocytopenic purpura, and have granted it priority review.

Priority review, a review period shortened to six months, is given to drugs that address significant unmet medical needs or can provide a significant improvement over currently marketed products. ITP involves increased destruction of platelets, or too few platelets being produced by blood, resulting in bruising and bleeding.

Ligand surged 40 cents, or 11.8%, to $3.79. And Glaxo shares edged up 26 cents, or 0.6%, to $44.18.

Also on the rise was ArthroCare(ARTC Quote), which makes minimally invasive products for soft tissue surgery. The company said Monday that its board has begun evaluating its financial and strategic alternatives. The company said it will consider the full range of available options, including a recapitalization, a stock repurchase, asset sales or a merger. It has hired Goldman Sachs to help in the review. Shares rose $2.81, or 7%, to $42.96.

Array BioPharma(ARRY Quote) jumped 19% after the company announced positive midstage data on an oral drug for patients with post-surgical dental pain. The company said the drug, ARRY-797, achieved its primary and secondary endpoints in the phase II study.

Array now plans a second phase II study in acute inflammatory pain comparing various doses to placebo and to Pfizer's (PFE Quote)Celebrex. The company also will begin a phase II trial on the drug in ankylosing spondylitis, a chronic inflammatory disorder. Shares of Array rose 87 cents, or 16%, to $6.47.

Wachovia analyst George Farmer raised his rating for OSI Pharmaceuticals(OSIP Quote) to outperform from market perform with a price target of $45 to $49, noting that competitive threat of Bristol Myers Squibb (BMY Quote) and ImClone's (IMCL Quote) Erbitux and AstraZeneca's (AZN Quote)Zactima may be overhyped. The optimism triggered a $1.72, or 4.8%, rise in the stock to $37.67.

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