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BioDelivery Sciences International Inc. (NASDAQ: BDSI) is bouncing higher today as investors anticipate FDA approval for its cancer pain drug. In a press release, the company said that it has reached an agreement with the Food & Drug Administration (FDA) and a review team on all aspects of the new drug application (NDA) for ONSOLIS. The regulatory agency informed BDSI that it "will not be issuing a review extension letter, as their action on the NDA is forthcoming."
"Although we cannot pinpoint the exact timing of when the FDA's action might occur, we have previously indicated that we expect a first half 2009 approval of the NDA for ONSOLIS. Based on our discussion with FDA last Friday, we should be within a few weeks of that target," explained Dr. Mark Sirgo, BDSI's president and CEO.
The shares of BDSI rocketed nearly 23% this morning in the wake of this news, touching a fresh 52-week high of $8.29 in early trading. In fact, the biotech issue has blazed a path steadily higher since bottoming near $2.50 in late February. BDSI now boasts a year-to-date gain of 133%, and the equity is perched comfortably atop support from its 10-day and 20-day moving averages.
The stock's rally should continue throughout the session as short sellers are forced out of their bearish bets. The number of BDSI shares sold short ballooned by a whopping 1,203% during the most recent reporting period, suggesting that many traders are betting against the security's short-term uptrend.
Elizabeth Harrow is an analyst and financial writer in the research department at Schaeffer's Investment Research. She is featured in the video series Schaeffer's Daily Q&A on SchaeffersResearch.com.
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