Shares of Delcath Systems went into free fall this morning, losing about two thirds of their value after the company announced that regulators from the FDA asked researchers to temporarily suspend enrollment for Phase II and Phase III trials of a delivery system used for treating liver cancer. The FDA wants to see an analysis on side effects before it meets with Delcath to discuss safety concerns. Two deaths were among the four serious adverse events reported from a late-stage study. The trials involved the use of the Delcath System with a drug used to treat tumors in the liver. Patients already enrolled in the trial will continue to be treated.
"We are prepared to meet with the FDA as soon as possible, and will present a thorough analysis of these GI episodes. We will update our investors promptly on resolution of this issue," said Richard L. Taney, president and CEO of Delcath.
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