NEW YORK (TheStreet) -- Shares of Onyx Pharmaceuticals (ONXX) tumbled on heavy volume late Thursday after the company delayed its new drug application for a proposed multiple myeloma treatment because of a Food and Drug Administration request for additional data on manufacturing the drug.
Onyx was originally planning to file the NDA by the end of this year, but it now anticipates the filing will occur in mid-2011 at the earliest. The company said it believes "minor variations" observed in the drug after a recent manufacturing run are related to equipment temperature variances, and that phase III trials for the drug remain on schedule.
"We are confident in the clinical and preclinical data package supporting the carfilzomib NDA and in our manufacturing strategy," said N. Anthony Coles, the company's president and CEO. "We believe that by providing this supportive data, we will strengthen our NDA package, thus enabling us to bring carfilzomib to patients with multiple myeloma as quickly as possible."
Onyx's stock was down 8.1% to $25.28 in extended trading with more than 1.2 million shares changing hands. Based on their regular session close at $27.50, the shares were already down about 11% so far in 2010, but had rallied somewhat since scraping a 52-week low of $19.54 on July 10.Another biotech taking a dive after the close was Cytori Therapeutics (CYTX), whose stock was off almost 13% to $4.65 on volume of around 63,000 after the company announced plans for a common stock offering. No word was given on the amount of shares the company is looking to sell. Meantime, DragonWave (DRWI) was gaining 6.6% to $7.10 on volume of more than 33,000 after the Canadian maker of packet microwave radio systems topped Wall Street expectations for its second-quarter earnings by a penny, and gave a bullish revenue outlook for revenue of $30 million in the third quarter. Among the big caps, Micron Technology (MU) was one of the most active issues in extended trading with volume of more than 4.4 million. The chip maker reported fiscal fourth-quarter earnings of $342 million, or 32 cents a share, on revenue of $2.49 billion, falling short of analyst estimates for a profit of 38 cents a share in the August-ended period on revenue of $2.65 billion. The stock was down 1.4% to $7.01 in late trades. Year-to-date, the shares are off more than 30%.
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