Delcath clarifies premature Hepzato staging site; no FDA decision; PDUFA Aug 14

DELCATH SYSTEMS, INC.

A vendor inadvertently published a staging site on Aug 4 suggesting possible Hepzato approval.
Delcath confirms it has not received any FDA decision regarding Hepzato as of filing date.
The PDUFA target date for Hepzato remains August 14, 2023.

item 7.01

DELCATH SYSTEMS, INC. filing history →

Source: SEC EDGAR

accession 0001193125-23-204024

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