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 (JNJ - Get Report) 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 Elan's (ELN) NanoCrystal technology.
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, Adam's Therapeutics (ARXT) 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.