The Bull and Bear Story on GTx's Pending Drug Decision: BioBuzz
By Adam Feuerstein 10/27/09 - 10:56 AM EDT Leave a Comment Stock quotes in this article: GTXI , ONXX , GILD , AMGN , CELG , GENZ , BMRN
MEMPHIS, Tenn. (TheStreet) -- Drugmaker GTx(GTXI Quote) has an important date with the Food and Drug Administration Friday Oct. 30, as the agency is set to issue an approval decision for the company's drug acapodene. GTx is seeking acapodene's approval as a treatment to reduce the risk of bone fractures in prostate cancer patients undergoing treatment with testosterone deprivation therapy.
Acapodene consists of an 80-mg dose of a drug known as toremifene, used by doctors for years (at a lower dose) to treat breast cancer patients.
The Acapodene bull story: The drug's pivotal study in prostate cancer patients, while demonstrating modest efficacy, did so with highly statistically significant results. No approved drug for this indication currently exists; the active ingredient, toremifene, was approved long ago and is well understood by doctors, albeit for women with breast cancer.
The Acapodene bear story: The drug's pivotal study produced minimal efficacy while demonstrating significant side effects and risk to patients, including blood clots and prolongation of the Qt interval, a measure of the heart's electrical cycle. [Bulls counter the last point by saying that there were no serious cardiac-related side effects linked to Acapodene, including torsades de pointes.]
GTx bears say the FDA isn't going to approve acapodene because the agency didn't convene an advisory panel. Bulls claim the FDA didn't hold an advisory panel because toremifene is not a new drug.
GTx shares closed were up slightly to $9.50 Tuesday but the stock has lost just under 30% since late September.