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Endocyte Back On Track To File Lead Candidate For EU Conditional Approval This Year

The U.S. biotech, which went public last year, will file EC145 and a companion diagnostic for conditional approval in Europe in platinum-resistant ovarian cancer based on findings from four Phase I and Phase II trials in the third quarter.

A shortage of Johnson & Johnson’s chemotherapeutic Doxil (liposomal doxorubicin) temporarily put on hold Endocyte Inc.’s Phase III trial of a targeted small molecule drug conjugate in platinum-resistant ovarian cancer, but the Indiana biotech is ready to resume its U.S. pivotal trial and will soon file for conditional marketing approval in Europe.

Endocyte has obtained approval to re-import its own supply of Doxil, which it purchased in the EU, to the U.S. to restart the pivotal trial; the J&J drug is being...

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