Drug and health stocks were generally tracking in line with the broader market indices Monday, as regulatory news spurred much of the action in sector.
Making one of the biggest moves Monday was
. Shares of the medical-device company soared more than 70% after the company said that the Food and Drug Administration granted 510(k) clearance in the U.S. to market its ADVANCE System, a device for physicians to test nerve conduction and perform invasive electromyography procedures. Shares of the Waltham, Mass., company were trading up $1.20, to $2.91 on more than 10 times the stock's average trading volume.
On the other hand, shares of biotech company
( MEDX) traded to a new 52-week low Monday on news of regulatory delays for ipilimumab, an investigational immunotherapy for patients with advanced metastatic melanoma. The Princeton, N.J., biotech company disclosed after the market close Friday that the FDA has requested additional overall survival data for the experimental drug, prompting Medarex and partner
to delay the biologics license application (BLA) for ipilimumab until at least 2009.
Shares of Medarex were down 8.1% at $7.36 in recent trading Monday; while shares of Bristol-Myers were up 0.5% at $22.25.
In other regulatory news,
( SGP) announced after Friday's close that the FDA had decided not to approve the companies' application for a proposed nasal allergy treatment. The companies had submitted a new-drug application for a single tablet that contains loratadine (the active ingredients of Claritin) and montelukast (the active ingredient of Singulair). Schering and Merck are "evaluating the agency's response."
Despite the expected delays, shares of Merck were trading Monday up 1.7% at $41.41, and Schering was up 0.8% at $18.79.
Wall Street analyst calls also played a role in a few health stock moves Monday. Credit Suisse lowered
( SHPGY) from neutral to underperform Monday. On Friday the drugmaker reaffirmed full-year 2008 guidance and expectations for revenue growth to be in the mid- to high-teens range, but it also said that it expects sales of Vyvnase -- a treatment for attention deficit and hyperactivity disorder (ADHD) -- to be at the lower end of its previously range of $350 million to $400 million. American depositary shares of U.K-based Shire were trading down 1.8% at $54.53.
Citigroup initiated coverage of
with a buy rating. CardioNet, a heart-monitor-device maker that came public last month in a lackluster IPO that priced on the low end of management's expectations, is slated to report first-quarter earnings before the opening bell Tuesday. Shares of the San Diego, Calif.-based company were trading up 9% to $ 23.44 Monday.
In a much different pre-earnings move, shares of
( BTRX) were trading 6.3% lower to $2.25 a day ahead of its report. The dermatology pharmaceutical company is slated to report quarterly results after the market close Tuesday.
Like the three major stock indices, health stock indices spent most of the day in the green: the Amex Biotechnology Index was tracking up 1.3% at 761.28; the Nasdaq Biotechnology Index was 0.9% higher at 813.17, and the Amex Pharmaceutical Index was recently up 0.1% at 304.37.
This article was written by a staff member of TheStreet.com.