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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.
News For CLDN From The Last 14 Days
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April 26, 2015
17:08 EDTCLDNCelladon reports Mydicar trial did not meet primary and secondary endpoints
Celladon announced that its phase 2b Cupid2 trial did not meet its primary and secondary endpoints. Cupid2 is a randomized, double-blind, placebo-controlled, multinational trial evaluating a single, one-time, intracoronary infusion of the cardiovascular gene therapy agent Mydicar, or AAV1/SERCA2a, versus placebo added to a maximal, optimized heart failure drug and device regimen. In the study, the primary endpoint comparison resulted in a hazard ratio of 0.93, defined as heart failure-related hospitalizations or ambulatory treatment for worsening heart failure. The secondary endpoint comparison, defined as all-cause death, need for a mechanical circulatory support device, or heart transplant, likewise failed to show a significant treatment effect. The efficacy endpoint analyses were performed on the 243 modified intent to treat population, which excludes clinical events that occurred in patients who did not receive Mydicar or placebo, or which occurred prior to dosing. All other exploratory efficacy endpoints were also inconsistent with a treatment effect. No safety issues were noted.
April 24, 2015
05:55 EDTCLDNStocks with implied volatility above IV index mean; CLDN WETF
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April 23, 2015
10:00 EDTCLDNOn The Fly: Analyst Initiation Summary
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06:18 EDTCLDNCelladon initiated with a Market Perform at BMO Capital
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05:58 EDTCLDNStocks with implied volatility above IV index mean; CLDN AMZN
Stocks with implied volatility above IV index mean; Celladon (CLDN) 383, Amazon.com (AMZN) 44 according to iVolatility.
April 22, 2015
13:55 EDTCLDNCelladon May options active into trial outcome
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April 20, 2015
15:11 EDTCLDNCelladon call volume and volatility elevated into trial outcome
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April 16, 2015
07:51 EDTCLDNCelladon volatility elevated into trial outcome
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April 15, 2015
10:31 EDTCLDNOptions with increasing implied volatility:
Options with increasing implied volatility: CLDN PNK TLM FOSL ARCP CSCO
April 14, 2015
10:50 EDTCLDNOptions with increasing implied volatility
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April 13, 2015
10:48 EDTCLDNOptions with increasing implied volatility
Options with increasing implied volatility: CLDN WETF EWH FOSL FXI TLM PRGO ATHN SYMC MAC
08:38 EDTCLDNCelladon volatility elevated into trial outcome
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07:35 EDTCLDNStifel 'cautiously optimistic' on outlook for Celladon trial
Stifel anticipates results from the CUPID2 trial of Celladon's Mydicar in the next two to four weeks, and the firm is "cautiously optimistic" about the trial's outcome. The firm says that the stock could rise significantly if the results are positive. It believes that Mydicar could address a multi-billion dollar commercial opportunity. Stifel keeps a $28 price target and Buy rating on the shares.

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