Buzz Stock of the Day- Anadys Pharmaceuticals Inc. (ANDS)

Posted on Saturday, August 1st, 2009

Shares of Anadys Pharmaceuticals, Inc. (NASDAQ: ANDS) soared today after the San Diego-based company announced that U.S. Food and Drug Administration regulators approved the design of a study for its hepatitis C treatment.

Shares were up $1.32, or 73 percent from yesterday’s closing price in morning trading, and closed the day 45 percent higher at $2.60 per share.

The company’s hepatitis C treatment, ANA598, has “demonstrated potent antiviral activity and good tolerability as a single agent in Phase 1, as well as preclinical properties indicative of likely synergy when used clinically in combination regimens,” according to CEO, Steve Worland, Ph.D. “This trial incorporates several attractive features designed to further enhance the competitive position of ANA598, including twelve weeks of triple combination treatment and a randomized exploration of shortening the overall duration of HCV therapy in conjunction with ANA598 treatment.”

The FDA approval establishes the length and goals of the study, which clarifies what is considered successful testing. The study was previously sidelined when three participants dropped out of testing after developing a rash.

Anadys said the FDA cleared the study protocol and patient dosing is expected to start in the next several weeks. Ninety patients are planned to be enrolled in the study, with 30 patients receiving the drug, ANA598, and 15 receiving a dummy drug at each dose level. The study would test 200 mg and 400 mg doses of the drug.

For the second quarter, the company posted a net loss of $6.5 million, or 21 cents a share, compared with a net loss of $7.1 million, or 25 cents a share, a year ago. The company’s cash, cash equivalents and securities available for sale as of June 30 totaled $30.6 million compared to $27.9 million as of December 31, 2008. These cash reserves are expected to fund operations into 2011.

“With our enhanced cash position, reduced cost structure and Phase II protocol allowance from the FDA, we are well positioned to continue advancing the development of ANA598 as a treatment for chronic hepatitis C,” Worland said in a statement.

Tags: ,

Leave a Reply