Delcath’s cancer system faces FDA setback, shares tank

Delcath Systems Inc said U.S. health regulators refused to accept the marketing application for its cancer drug delivery system, sending its shares down 36 percent in early trade.

The company expects to submit a formal meeting request this week to the U.S. Food and Drug Administration and plans to resubmit the marketing application by September 30.

“The FDA’s letter requested information involving manufacturing plant inspection timing, product and sterilization validations and additional safety information… as well as additional statistical analysis clarification,” CEO Eamonn Hobbs said in a statement.

Delcath’s chemosaturation system is designed to deliver high doses of the generic chemotherapy drug melphalan directly to the liver via the hepatic artery.

The system aims to minimize side effects by filtering the highly toxic drug out of the blood stream as it leaves the liver, but some of the drug leaks out.

Delcath System’s shares, which have risen 40 percent since October on speculation that drugmaker Bristol-Myers Squibb Co may bid for the company, were down 36 percent at $7.27 on Tuesday on Nasdaq.

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(Reuters)