is expanding the development of its blood infection drug CytoFab. Shares were lower by 1.1% at $60.59.
After consultation with the Food and Drug Administration and regulators in the European Union, the pharmaceuticals giant has decided to add a 480-patient trial to support a larger study. The larger study alone wouldn't have been sufficient for approval, the company says. The additional study is slated to begin in the second half of 2007.
Shares of specialty pharmaceutical company
( NVD) jumped 8% following an announcement that regulators approved its oral spray for relieving and preventing angina caused by coronary artery disease.
Food and Drug Administration's approval of NitroMist is a major milestone for NovaDel, as it represents the first approval of a drug using our proprietary oral spray technology," said Jan Egberts, president and CEO of NovaDel. "With this approval, we will now focus our resources on the rapid advancement of our pipeline of compounds that promise to provide faster onset of action and more patient-friendly dosing."
North American marketing rights to the drug have been licensed to
( PRX). Novadel expects a payment from Par as a result of the product's approval. Shares of Novadel were up 10 cents to $1.35.
( DIGE), a maker of gene-based diagnostic tests, saw record quarterly earnings thanks to an increase in sales of its test to detect human papillomavirus, a disease linked to ovarian cancer. The stock was up 3.4% at $47.29.
The company earned $5.1 million, or 22 cents a share, in the fiscal 2007 first quarter, compared with $1.3 million, or 6 cents a share, a year ago. Excluding a $2.1 million charge for stock-based compensation expenses and tax-related adjustments, Digene earned $6.6 million, or 28 cents a share.
Revenue for the quarter was up 38% to $46.1 million, with worldwide HPV test revenue up 47% to $41.6 million. In the U.S., HPV test revenue reached $35.7 million, up from $23.4 a year ago. The company says it expects approximately $197 million in revenue for the full year and earnings of $1.06 a share, excluding certain charges.
saw its shares tumble a day after the company reported another delay for its experimental insomnia drug Indiplon.
On Thursday, after the markets had closed, Neurocrine said it would seek government approval of an immediate-release version of Indiplon during the summer of 2008. In September, it predicted it would file an application for clearance with the Food and Drug Administration by the second quarter of 2007.
Following the announcement, shares of Neurocrine plunged $3.18, or 28.8%, to $7.85.
Neurocrine also released third-quarter financial results. For the three months ended Sept. 30, the company lost $39.1 million, or $1.03 a share, reversing a profit of $26.2 million, or 71 cents a share, for the same period last year. EPS figures exclude accounting for share-based compensation. Neurocrine took a one-time charge of $9.5 million during the recent quarter for severance and outplacement costs.
Third-quarter revenue dropped to $1.1 million from $64.7 million due primarily to a $50-million milestone payment during the year-ago quarter.