The newly installed CEO of cancer diagnostics firm Neoprobe (NYSE Amex:NEOP) said the company is again delaying its FDA application to commercialize its radiopharmaceutical Lymphoseek.
As recently as earlier this month, the company said it expected in the second quarter to file with the U.S. Food and Drug Administration a New Drug Application (NDA) for Lymphoseek, a tracing agent that helps surgeons identify cancerous lymph nodes in patients with breast cancer or melanoma. If the NDA is approved, Neoprobe could begin marketing Lymphoseek and start raking in sales. The company estimates Lymphoseek’s market value at (pdf) $450 million.
But now, new CEO Mark Pykett said the company will delay the filing until the third quarter because it needed to enroll additional patients in a phase 3 clinical trial of Lymphoseek. Those patients are now enrolled and Neoprobe said it expects to publicly announce top-line data from the trial in May and full data in June.
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“We’ll do everything in our control to move the submission date up,” but the third quarter is the most likely time frame, Pykett said in a Tuesday morning conference call with analysts and investors. “We’ll try to expedite the filing without compromising quality or increasing risk.”
Investors apparently weren’t too happy with Pykett’s announcement of the delay. In midday trading, Neoprobe’s shares were down about 10 percent to $3.84.
This isn’t the first time Neoprobe has delayed filing Lymphoseek’s NDA. The company had planned to do it by the end of 2010, but in October announced a delay after the FDA requested more data.
Pykett was announced as CEO yesterday and will be taking over for David Bupp, who’d held the CEO role for 12 years. Neoprobe hired Pykett in November as its chief development officer.
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Previously, Pykett founded Massachusetts-based Talaris Advisors, a drug development consulting firm. He also was chief operating officer with Alseres Pharmaceuticals, which develops drugs for central nervous system disorders.
