Endocyte soars on MAA plans
Endocyte Inc. (NASDAQ:ECYT) gained $2.39 (25%) to $11.88 on Tuesday after announcing plans to submit applications in the EU for its lead cancer candidate and companion diagnostic based on Phase II data instead of waiting for Phase III data. After consulting with EMA, the company now plans to submit MAAs seeking conditional approval of EC145 to treat platinum-resistant ovarian cancer in patients that overexpress folate as identified by companion diagnostic EC20. The submissions will be based on data from the Phase II PRECEDENT trial, which showed EC145 plus chemotherapy met the primary endpoint of significantly improving progression-free survival (PFS) vs. chemotherapy alone. The company said the improvement was even more substantial in patients selected with EC20. Endocyte would not disclose a time frame for the MAA submissions. ...