The Food and Drug Administration has agreed to review an application by Amgen Inc. for a drug that reduces cholesterol, the company announced on Monday.
The Thousand Oaks biopharmaceutical company had submitted an application for evolocumab in August based on studies with about 6,800 patients. The company expects an FDA decision by late August 2015.
Amgen is tyring to get evolocumab to market before rivals can launch similar drugs, which reduce blood cholesterol levels using a different molecular mechanism than statins currently on the market.
Last month, Amgen filed a lawsuit against Sanofi and Regeneron Pharmaceuticals Inc. for patent infringement. The companies are jointly developing an experimental drug alirocumab, which is similar to evolocumab.
Shares of Amgen closed up $3.45, or more than 2 percent, to $163.09 on the Nasdaq.
Qualstar Corp. posted on Monday a narrower net loss in the fiscal first quarter as the company continues to turn around its finances.
The Simi Valley manufacturer of tape storage and power supply products reported a net loss of $322,000 (-3 cents a share) in the fiscal first quarter ended Sept. 30, compared with a net loss of $2.5 million (-21 cents) in the same period a year earlier. Revenue increased 50 percent to $3.3 million.
Analysts estimates are unavailable for the company.
“Our continued growth and the momentum gained directly reflects our customer’s long-term commitment to Qualstar’s products and services,” said Chief Executive Steven Bronson in a prepared statement.
Shares closed up 2 cents, or 1.7 percent, to $1.18 on the Nasdaq.
Unico American Corp. reported on Monday that it swung to a profit in the third quarter on higher revenue.
The Woodland Hills company, which sells casualty, property and health insurance through its Crusader Insurance Co. subsidiary, reported net income of $300,000 (1 cent a share) for the quarter ended Sept. 30, compared to a net loss of $400,000 (-7 cents) for the same period last year. Revenue rose about 1 percent $7.8 million.
No analysts follow the company, and management provided no statement about its operations.
Shares closed down 11 cents, or nearly 1 percent, to $11.88 on the Nasdaq.