Regulatory updates and a slapdash sampling of news nudged a few biotech stocks in either direction on an overall flat start to the week.
Johnson & Johnson
on Monday submitted a new-drug application (NDA) to the Food and Drug Administration for paliperidone palmitate, an injection to treat and prevent symptoms of schizophrenia. The drug uses
, which receives royalties on sales of Johnson & Johnson's current market-leading schizophrenia drug, Risperdal Consta, gave up 34 cents, or 2%, to $16.88.
Elan's shares traded up 48 cents, or 2.1%, to $23.26. Johnson & Johnson was trading up 70 cents, or 1.1%, to $65.
In a regulatory update,
said Monday that it received an approvable letter from the FDA related to its NDA for Mucinex with Codeine extended-release tablets for cough associated with common cold, inhaled irritants and stable chronic bronchitis.
Adam's said the FDA requested additional data to support the use of the product with food and suggested various approaches to address the issue. The company doesn't expect the development to impact its financial guidance for fiscal 2008.
The company also said it expects fiscal 2008 profit to reach the high end of its guidance, as the FDA forces retailers to stop selling unapproved timed-release guaifenesin combination products that compete with its Mucinex and Mucinex DM. Shares rose $2.30, or 5.7%, to $42.88. The stock is a component of the Nasdaq biotechnology index, which was down 2.59, or 0.3%, to 888.26.
Wyeth Consumer Healthcare
said Monday it is voluntarily recalling and replacing several Robitussin and Children's Dimetapp Cold & Congestion products with dosage cups that do not have a half-teaspoon mark. The mark is the recommended dose for children age 2 to 6 years old. Shares nudged down 15 cents, or 0.3%, to $48.76.
Also with a light decline,
and biopharmaceutical company N30 Pharma said they made a licensing agreement regarding respiratory use of an s-nitrosothiol drug candidate. The companies didn't disclose financial terms. NitroMed's shares fell 5 cents, or 3.3%, to $1.46.
And last, in earnings, medical device company
Vnus Medical Technologies
reported a third-quarter loss of $2.17 million, or 14 cents a share, compared to a loss of $2.52 million, or 17 cents a share, in the year-ago quarter. The company said net revenue rose 47% to $17.5 million. Analysts surveyed by Thomson Financial had expected a loss of 18 cents a share on revenue of $16.2 million.
Looking ahead, the company is predicting a fourth-quarter net loss in the range of $1 million to $1.5 million, or a loss of 6 cents to 10 cents a share. Shares added 23 cents, or 1.5%, to $15.83.