Acusphere Stock Temporarily Halted During FDA Panel on Heart Imaging Drug

12/10/08

(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.

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  • Bob S.

    You moron. Trading was temporarily halted due to the meeting.

  • F.J.

    Where does this mickey mouse outfit get its writers? From the nearest high school? This Ryan McBride person knows zero about what he’s writing about.

  • John

    Are you going to correct this article or just continue to live in ingnorance?

    Trading is halted for the day while Imagify is reviewed by the FDA Advisory Board!

  • Zigmond Floyed

    With all the hoopla since Monday, did anyone actually read the quoted FDA report? Where is the report published? Is it publicly available? Why are there no references to this FDA document available? This is worse than yellow journalism.

  • Jimmy

    Since you basically corrected its entire contents, perhaps the best thing is to just pull the darn thing! The headline alone is bruisingly inaccurate, hurts the company and you.

  • Jimmy

    I was referring to the original headline that still shows as “bounced” on google, not the one you have modified here.

  • Zigmond Floyed

    Now you are quoting the AP report which itself does not provide references. Show me the money!
    Where is the real source? Every report on the web, including WSJ neglects to provide the source. Conspiracy…:)?

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    Here’s a link to the FDA briefing document that the AP report was based on. We’re sorry for any confusion our earlier report may have caused.

    http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4390b1-01-FDA.pdf

  • Zigmond Floyed

    Interesting. I read the report and I believe that I understand its significance. The FDA must protect the public and the document presents the data that the FDA has collected thus far, to be addressed by the external experts panel at the review meeting. Nothing in the document warrants the paranoia that is reflected in the media. However, whoever came with the saying “even paranoids have enemies” was probably right!

  • Zigmond Floyed

    In this day and age we cannot allow corporate entities, politicians and journalists to do our thinking for us.

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