Monday, Biodel Inc. (BIOD) announced that the FDA has accepted the company's new drug application seeking approval to market VIAject for the treatment of diabetes.
VIAject, Biodel's lead product candidate is a rapid-acting form of injectable human insulin for meal-time use by patients with Type 1 or Type 2 diabetes. RTTNews had alerted readers to the stock on February 11 when the stock was trading at $3.65.
The company said that VIAject has been tested in more than 875 patients who participated in phase I, II and III clinical trials of the drug in the United States, Germany and India. Biodel submitted its marketing application to the regulatory agency on December 30, 2009 and expects the action date to be October 30, 2010.
BIOD, which has been trading in the range of $3.22-$6.02 over the past twelve months, rose as much as 14% to $4.55 in early trading, before settling down to the current trading price of $4.33.
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