Endocyte (ECYT) shares rose sharply Friday on a double dose of positive news for its targeted cancer drug vintafolide.
European regulators issued a positive opinion, recommending conditional approval to vintafolide for the treatment of women with advanced ovarian cancer. Endocyte expects Europe to issue the final approval decision in two or three months. Once approved, vintafolide (under the brand name Vynfinit and coupled with a companion diagnostic test) will be sold in Europe via an existing partnership with Merck (MRK).
Endocyte and Merck also reported positive results from a phase IIb study of vintafolide in non-small cell lung cancer. The combination of vintafolide and the chemotherapy drug docetaxel reduced the risk of disease progression or death by 25% compared to docetaxel alone.
It was very good morning for Endocyte and its shareholders, with the stock up 88% to $27.50.
Before digging into the details of the European approval and the lung cancer study, some praise and reckoning is required.
Congratulations to TheStreet contributor David Sobek, an Endocyte bull. Sobek laid out the bull case for a positive European approval of vintafolide in a column published in October. Endocyte was a $10 stock at that time.
I learn towards a positive approval recommendation on vintafolide from Europe, but Endocyte's application is not without risks. The company has told investors its interactions with European drug reviewers to date have been generally supportive of vintafolide but we all know this doesn't insure a favorable outcome. With that said, I'm bullish about Endocyte and its ovarian cancer drug regardless of the European approval decision.