NEW YORK (Reuters) - Celladon Corp said its heart failure gene therapy Mydicar failed to meet its primary and secondary endpoints in an important trial.
“We are surprised and very disappointed that Mydicar failed to meet the endpoints in the CUPID2 trial, and we are rigorously analyzing the data in an attempt to better understand the observed outcome,” Celladon’s chief executive, Krisztina Zsebo, said in a statement on Sunday.
According to the company, the gene therapy failed to show a significant treatment effect when compared to placebo.
The company said it plans to hold an investor conference call to discuss the trial on Monday.
Investors have been waiting for the test data, with the options market expecting an explosive move from the shares when it is released.
Gene therapies aim to insert corrective genes into malfunctioning cells. Celladon’s Mydicar is a virus designed to deliver a gene that reconstitutes an enzyme responsible for heart muscle contraction.
The treatment was granted both “breakthrough” and “fast-track” status by the U.S. Food and Drug Administration.
Shares of Celladon closed at $13.68 on the Nasdaq on Friday.
Reporting by Michael Erman; Editing by Leslie Adler