Three weeks after receiving quite the regulatory scare, BioMimetic Therapeutics yesterday said the Food & Drug Administration won't ask it to overhaul its research of a potential treatment for foot and ankle fusions.
Leaders at the Franklin-based biotech (Ticker: BMTI) have talked regularly with FDA officials since the agency issued what it calls an early communication about the potential for increased cancer risks of a Johnson & Johnson product that uses the same regenerative compound as BioMimetic's GEM OS1. Yesterday, the feds said BioMimetic will not have to alter its research process for GEM OS1.
"We believed this letter was important in order to provide accurate and clear guidance to our clinical investigators. With this achieved, we look forward to completing our study in a timely fashion," said President and CEO Sam Lynch.
The news – released after regular market hours – pushed BioMimetic shares up 9 percent to about $10 in after-hours action. But that still leaves them $5 below where they traded before the FDA's J&J move and down 42 percent year to date.
NASDAQ to local bank: You alright
In other regulatory news, Tennessee Commerce Bancorp has been told by NASDAQ officials that its executives are no longer required to fly to New York to discuss the internal review that delayed the filing of its annual report.
Tennessee Commerce brass had been asked to meet with the NASDAQ's Listing Qualifications Panel by the end of May, but the exchange said the company's filing last week of a 10-K with unchanged financial statements makes the meeting moot.
Shares of Tennessee Commerce (Ticker: TNCC) at $18.29 Monday, up 1.3 percent on the day but down about 27 percent so far this year.
Clarcor exec cashes in
Here's something we haven't seen much lately: A local insider selling a big chunk of shares into relative strength. Bruce Klein, VP and CFO at filtration products maker Clarcor Inc., last Friday sold almost $2 million worth of stock on the open market, trimming his stake in the company by more than a fifth.
Since bottoming around $28 in the fall of 2006, shares of Franklin-based Clarcor (Ticker: CLC) have risen more than 40 percent. So far in 2008, they're up about 4 percent, closing Monday at $39.54.