Acusphere Stock Temporarily Halted During FDA Panel on Heart Imaging Drug
(UPDATE: This story has been corrected from an earlier version, which said Acusphere stock has been “bounced” from the Nasdaq exchange. The shares haven’t been de-listed, but trading in Acusphere has been temporarily halted today while an FDA advisory panel meets to discuss whether to recommend approval of its lead product candidate, Imagify. This is a standard procedure with Nasdaq that small biotech companies often request because of the volatility in stock prices that can result from these advisory recommendations. Trading is expected to resume tomorrow in accordance with Nasdaq rules, after the panel vote has been recorded.
The previous story also referred to critical comments made by the FDA review panel. Those comments were actually made by the FDA staff, in briefing documents posted online. The FDA advisory panel, composed of outside experts, is making its comments in public today. We apologize for the errors.)
Two days after FDA staff reviewers criticized the safety and effectiveness of its experimental cardiovascular-imaging agent, Watertown, MA-based Acusphere (NASDAQ:ACUS) says that Nasdaq has halted trading of the firm’s common stock. The imaging agent, perflubutane polymer microspheres (Imagify), is Acusphere’s best candidate to become the firm’s first moneymaker.
Acusphere’s imaging agent is designed to show how blood moves through the heart using ultrasound as a means of spotting heart disease; it’s a potential alternative to conventional radioactive tracers that are viewed with special cameras. The company told us last year that the imaging product had the potential to be a big seller in a whopping $2 billion market. But on Monday, according to this AP report, the FDA staff review said that animal studies indicated that the agent caused increased blood pressure and other abnormalities.
According to Google Finance, Acusphere has been a penny stock since July 2007, and the stock closed on Tuesday at 30 just cents per share.