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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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March 31, 2015
17:43 EDTCLDNCelladon files to sell 7M shares of common stock
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16:50 EDTCLDNOn The Fly: Closing Wrap
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09:28 EDTCLDNOn The Fly: Pre-market Movers
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March 30, 2015
19:42 EDTCLDNCelladon climbs after Q4 results, CUPID 2 update
Celladon shares rose in after-hours trading after the clinical-stage biotechnology company reported fourth quarter earnings and stating that the company's CUPID 2 top-line data release is on track for late April. WHAT'S NEW: Celladon reported a Q4 consolidated net loss of $11.3M vs. a loss of $6.18M last year. WHAT'S NOTABLE: Chief Executive Officer Krisztina Zsebo stated, "Following last year's financing activities, we are well positioned to advance our pipeline and development initiatives in 2015." The company noted that it remains on track to un-blind the data and announce top-line results from this study in late April 2015 and that if it proceeds with the ongoing activities beyond a specified termination period following the un-blinding of CUPID2, Celladon would commit to a multi-year agreement for the future commercial supply of Mydicar drug substance. PRICE ACTION: In after-hours trading, Celladon rose 84c, or 3.88%, to $22.51. Note that Celladon shares were up 58c, or 2.75%, to $21.67 intraday with elevated call option implied volatility ahead of the company's results and trial outcome.
18:51 EDTCLDNOn The Fly: After Hours Movers
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18:12 EDTCLDNCelladon reports CUPID 2 topline data release on track for late April
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16:07 EDTCLDNCelladon reports Q4 consolidated net loss $11.3M, consensus (36c)
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14:11 EDTCLDNCelladon volatility elevated into Q4 and trial outcome
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March 27, 2015
16:43 EDTCLDNEnterprise Partners reports 8.3% passive stake in Celladon
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March 26, 2015
13:34 EDTCLDNCelladon volatility elevated into Q4 and trial outcome
Celladon April call option implied volatility is at 173, May is at 322, June is at 277; compared to its 7-week average of 220 according to Track Data, suggesting large May price movement into the expected release of Q4 results on March 31 and outcome of the CUPID2 trial.
March 25, 2015
10:51 EDTCLDNOptions with increasing implied volatility
Options with increasing implied volatility: CLDN CMG CREE AMZN ISRG MAC UA VMW SLXP
March 24, 2015
19:40 EDTCLDNOn The Fly: After Hours Movers
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16:12 EDTCLDNCelladon, Novasep execute Mydicar API supply agreement
Celladon and Novasep announce that they have signed a Development, Manufacturing and Supply Agreement pursuant to which, if supported by upcoming Mydicar clinical data, Novasep would manufacture Mydicar drug substance through 2018 with extension options through 2020. The contract follows an earlier letter agreement concerning the initial process transfer of Mydicar and pre-validation studies, which was signed in December 2014. The new agreement continues the work necessary for Novasep to achieve GMP production of Mydicar drug substance. Under the terms of the agreement, Novasep and Celladon would conduct the process transfer, development, facility retrofitting and scale-up activities necessary to carry out production of Mydicar drug substance in a 2000L bioreactor at an enhanced bioproduction plant in Seneffe, Belgium. GMP operations are planned to start in 4Q16 and continue through 2018. An option to extend through 2020 will be determined based on Celladon's requirements for the Mydicar drug substance. Celladon has the right to terminate the agreement, exercisable for a specified period of time following the un-blinding of the data from the CUPID2 study, if Celladon concludes in good faith that the CUPID2 data is such that Celladon does not require production of Mydicar drug substance at the Novasep facility.

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