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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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November 20, 2015
07:19 EDTCLDNAvalanche Biotechnologies names Paul Cleveland as CEO
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November 19, 2015
09:16 EDTCLDNOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Keurig Green Mountain (GMCR), up 19%... (CTRP), up 11.8%... (CRM), up 5.4%... Perry Ellis (PERY), up 4%. ALSO HIGHER: Celladon (CLDN), up 55.9% after signing a merger agreement with Eiger BioPharmaceuticals... StemCells (STEM), up 45.7% after Phase II Pathway Study data shows motor improvement in SCI patients... UniPixel (UNXL), up 36.1% after receiving an initial mass production order from a Japanese PC manufacturer... Anavex Life Sciences (AVXL), up 16% after announcing preparation of regulatory filings based on guidance from FDA... Plug Power (PLUG), up 3.7% after securing Colruyt Group as its next GenDrive fuel cell customer in Europe. DOWN AFTER EARNINGS: Stage Stores (SSI), down 14.7%... JinkoSolar (JKS), down 7.5%... Best Buy (BBY), down 5.2%... Semtech (SMTC), down 7.5%. ALSO LOWER: AMAG Pharmaceuticals (AMAG), down 8.4% after receiving a complete response letter from the FDA its application seeking approval for a single-dose vial of Makena... Titan International (TWI), down 8.3% after being downgraded to Sell from Neutral at Goldman... Sunedison (SUNE), down 5.5% after Reuters reported that Blackstone (BX) is not interested in SunEdison investment.
05:33 EDTCLDNCelladon to host conference call
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05:20 EDTCLDNCelladon CEO Paul Cleveland to step down, Fredrik Wiklund to succeed
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05:18 EDTCLDNCelladon, Eiger BioPharmaceuticals sign merger agreement
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