(Celladon Corp. NASDAQ: CLDN)
A Heart Stopping Move
Celladon shares traded lower by 80% in Monday’s session after the company announced that is trial gene therapy drug, Mydicar, failed to demonstrate any improvements in results in the Phase IIb study.
The CEO of Celladon, Krisztina Zsebo, Ph.D. had the following comments:
“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. We would like to express our sincere gratitude to our investigators and patients who participated in the study. At the same time we are evaluating our other programs in order to determine the best path forward to maximize shareholder value.”
Subsequent to the failed trial announcement, a few analysts hit the company with significant downgrades.
- Roth Capital issued a downgrade to neutral from buy
- Wedbush downgraded to neutral from outperform and also slashed the price target to $3 from $29
Analysts from Wedbush commented further on the results:
“In the primary endpoint, time to recurrent heart failure related events, Mydicar had a HR of 0.93 (p=0.81) vs placebo.” However, no clinical benefit was established for any of the other endpoints, including “time to first terminal event, improvement in NYHA classification, 6 MWT, and QoL.”
“Further Mydicar development in AV-fistula maturation failure is a possibility, given the different biological role SERCA2a is believed to play in the pathology of fistula failure. CLDN had previously guided to advancing the preclinical fistula program into a Phase 2b study later this year.”
Unfortunately, Celladon Corp has very little, if anything to rely on since the failure of Mydicar, the most prevalent experiment for gene therapy conducted to date. The company does maintain a pipeline of other various drugs, however they are only in pre-clinical stages. Adding to the bleak outlook, Celladon’s balance sheet at year end 2014 shows it had $85 million in cash which puts shares of Celladon at $3.57/share.