Shuffle Master, Navidea shares drop after hours
LOS ANGELES (MarketWatch) -- Shares of
Shuffle Master (SHFL) stock fell 7.7% at $14.24 as the company said fiscal third-quarter earnings were $10.4 million, or 18 cents a share, missing the Thomson Reuters estimate by 2 cents a share. Revenue rose nearly 9% to $63.4 million, below the $68 million Wall Street had projected. Read more about Shuffle Master's results.
Navidea (NAVB) shares tumbled 36% at $2.23. The company said it received a "complete response letter" from the U.S. Food and Drug Administration about its new drug application Lymphoseek, a lymphatic tracing agent. A complete response letter is sent when a drug application isn't ready for approval.
The FDA's decision was centered on a third-party Lymphoseek contract manufacturing and wasn't related to any efficacy or safety data related to Lymphoseek, according to Navidea.
Receiving the letter from the FDA "is clearly disappointing," Navidea Chief Executive Mark Pykett said in a statement. "We are already working closely with the FDA and our third-party contract manufacturers to address all requirements to support the shortest possible NDA resubmission and review," The company also said it remains confident its clinical data demonstrate the value of Lymphoseek in accurately identifying lymph nodes that most likely harbor cancer.
Meanwhile, shares of
In dayside trading, U.S. stocks were weighed by a selloff after a flurry of headlines about Spain's debt crisis, and by a nearly 4% drop in shares of