This Day On The Street
Continue to site right-arrow
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Celldex Reports Fiscal 2013 Business/Financial Results And Outlines 2014 Strategy

HAMPTON, N.J., March 3, 2014 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business and financial highlights for the fourth quarter and year ended December 31, 2013 and outlined the Company's major clinical development goals for 2014.

"This past year was transformational for Celldex as we continued to make strides in cultivating one of the most robust, well-staged pipelines in immuno-oncology," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "We enter 2014 with five candidates in the clinic, including rindopepimut and glembatumumab vedotin in registration studies. By year-end, we anticipate the initiation of four new Celldex-sponsored clinical trials and several investigator-sponsored studies, including multiple combination regimens. These combination studies are designed to address what we believe is the next great opportunity for the immuno-oncology field—further unlocking the power of the immune system to deliver the greatest benefit to the largest population of patients possible. With last year's successful financing of the Company and current cash projected to fund our planned activities through 2016, we look forward to what we believe will be an exceptionally productive year."

2013 Program Updates:

Rindopepimut ("rindo"; CDX-110) in EGFR v III(v3)-Positive Glioblastoma (GBM):

  • Celldex continues to actively enroll newly diagnosed patients with GBM in ACT IV, the Phase 3 registration study. More than 200 sites are currently open to enrollment across 24 countries. The Company continues to anticipate completion of enrollment in mid-2014.  
  • Celldex announced the presentation of four- and five-year survival data from the Phase 2 rindopepimut clinical program in frontline GBM (3 studies; pooled n=105) in November. Survival data suggests a substantial and continuing survival benefit in comparison to a matched historical control dataset, at the median and at all other time points evaluated. Eighteen percent (18%) of patients from the Phase 2 frontline rindopepimut program were alive at four years and 14% were alive at five years. No patients in the matched historical control dataset survived beyond three years.  
  • In November, positive interim data from the ReACT study in recurrent GBM were presented in an oral session at the Annual Meeting of the Society for Neuro-Oncology. The data demonstrated promising signs of clinical activity in advanced patient populations, including patients both naive and refractory to Avastin ®. Enrollment in ReACT is expected to be completed in late 2014 with data anticipated by year-end 2014.

Glembatumumab vedotin ("glemba"; CDX-011) targeting gpNMB in multiple cancers:

In December, Celldex initiated a randomized, accelerated approval study (METRIC) of glembatumumab vedotin in patients with metastatic triple negative breast cancer that overexpresses the tumor associated marker gpNMB. The METRIC study is expected to include up to 100 sites in the United States, Canada and Australia. The glembatumumab vedotin program will expand into additional indications in 2014 (outlined below).

1 of 6

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 18,132.70 -81.72 -0.45%
S&P 500 2,104.50 -6.24 -0.30%
NASDAQ 4,963.5270 -24.3630 -0.49%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs