Small-Cap Stock Spotlight: Columbia Laboratories Inc. (CBRX)
Shares of Columbia Laboratories Inc. (NASDAQ: CBRX) rose 34.3% to $1.47 Wednesday, recovering from the prior day’s 54% plunge. Investors pulled back from Columbia Laboratories on Tuesday after news broke that the company’s progesterone gel to reduce the risk of preterm birth, Prochieve, failed in U.S. clinical trials.
Shares of the specialty drug developer have plummeted 44.7% in the last five days; 41.0% in the last month; and 44.9% year-to-date.
In a December 22 report released on Tuesday, the FDA staff stated: “The information and data in this application do not support the efficacy of progesterone gel compared with placebo in reducing the risk of preterm births before 33 completed weeks.”
Columbia Laboratories spokewoman Amy Raskopf, in a telephone interview with Bloomberg, stated that the FDA staff based its determination on data from narrow groups in a global study. “This is a global study. It was designed as a global study. FDA agreed.”
An FDA advisory panel is scheduled to meet Jan. 20 to review the gel’s risks and benefits.
Columbia Laboratories in December issued a release that announced purported results of Prochieve clinical trials, which include a significant reduction of risk of preterm birth and neonatal morbidity. CBRX shares jumped significantly on the news.
Based in Livingston, NJ, Columbia Laboratories engages in the development of drugs that improve treatment options for women’s reproductive healthcare using its novel bioadhesive delivery technologies, which, the company claims, optimize drug delivery in a controlled, sustained manner.
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