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Stock Market & Financial Investment News

News Breaks
April 10, 2014
08:42 EDTCLDNCelladon's Mydicar candidate granted breakthrough therapy designation by FDA
Celladon's lead product candidate, Mydicar, has been granted breakthrough therapy designation by the FDA for reducing hospitalizations for heart failure in NYHA class III or IV chronic heart failure patients who are NAb negative. This designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. Celladon is currently evaluating Mydicar in the Phase 2b CUPID 2 trial to determine its efficacy in reducing the frequency of and/or delaying heart failure-related hospitalizations. The company expects to report results in April 2015.
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January 22, 2015
11:08 EDTCLDNCelladon price target raised to $29 from $17 at Wedbush
Wedbush sees a 60% chance that Celladon's Mydicar will demonstrate a statistically significant benefit versus placebo in the primary endpoint of its Phase 2 CUPID2 trial involving patients with advanced systolic heart failure. The firm sees only a 30% likelihood that the primary endpoint won't be met, and a 10% chance that the outcome is so dramatic that the treatment will be approved by the FDA on an accelerated timetable. The firm says that, after other events that affected the company have passed, the stock's risk/reward ratio is almost entirely based on the possible outcome of the CUPID2 trial. It keeps an Outperform rating on the shares.

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