Celladon (CLDN) Stock Pummeled After Negative Trial Results, Downgrade

Shares of Celladon Corp. (CLDN) were down -10.10 or -73.83 percent to $3.56 per share in Monday's premarket, after news over the weekend that the company's drug for advanced heart failure had failed to meet primary and secondary endpoints in trials. In addition, due to the news, the stock was downgraded significantly by an analyst. Celladon stock closed at $13.68, down -0.26 or -1.87 percent in Friday's regular trading session.

San Diego, California based Celladon Corp. is a clinical stage biotechnology company focusing on developing gene therapy for calcium dysregulation and for diseases that have extraordinary unmet medical needs. The company's research into calcium dysregulation has found that the condition is implicated in various important and complex medical conditions including heart failure.

The company's lead programs target Sarco/endoplasmic reticulum Ca2+ ATPase, or SERCA enzymes. The enzymes play an important role in regulating intra cellular calcium in human cells. Celladon's lead product, MYDICAR uses gene therapy to target SERCA2a, an enzyme which is deficient in patients with heart failure and is responsible for muscle contractions in the heart. Celladon Corp. had its initial public offering in January of 2014 at $8.00 per share.

Celladon announced yesterday that their cardiovascular gene therapy agent, MYDICAR had failed in meeting both its primary and secondary endpoints in a Phase 2b CUPID2 trial. The CUPID2 trial is an international, placebo controlled, double blind randomized trial that evaluates a single intracoronary infusion of MYDICAR versus a placebo in the treatment of heart failure.

In the primary endpoint comparison, MYDICAR was found to have affected patients statistically equal to a placebo in treating worsening heart failure in hospitalized and ambulatory patients. The second endpoint comparison was in the administering of MYDICAR in what is defined as "all cause death , or the need for a mechanical device for circulatory support or a heart transplant. Neither endpoint analysis study showed a significant treatment effect.

Krisztina Zsebo, PhD, Celladon's Chief Executive Officer said in the company's press release that, "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.

There were high expectations for Celladon's MYDICAR gene therapy treatment. The treatment was previously granted both a fast track and breakthrough status by the U.S. Food and Drug Administration. In addition and as a consequence of the disappointing news, Wedbush analyst, David Nierengarten downgraded Celladon stock's rating from "outperform to "neutral and cut its one year price target on the company from $29.00 to $3.00 per share.

Apparently, investors have decided to bail on the stock, taking it down over 10 points, or over three quarters of its value, in this morning's premarket. Nierengarten's price target could be reached later in this morning's regular trading session.

Other News About CLDN

Celladon Reports Fourth Quarter and Year-End 2014 Financial Results and Recent Highlights

Company reported net losses for the quarter and for the full fiscal year.

Novasep and Celladon Execute MYDICAR API Supply Agreement

Celladon signed a manufacturing and distribution agreement with French company Novasep.

Other Stocks in the News

Capgemini buys IGATE for $4 billion

Purchase will make North America the French company's largest market.

Coronado Biosciences Changes Its Name to Fortress Biotech

The company will begin under the new name and ticker, FBIO as of tomorrow's market opening.