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celldex therapeutics inc (TCE1) Snapshot

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celldex therapeutics inc (TCE1) Details

Celldex Therapeutics, Inc., a biopharmaceutical company, focuses on the development, manufacture, and commercialization of novel therapeutics for human health care primarily in the United States. Its lead drug candidates include rindopepimut (CDX-110), a targeted immunotherapeutic in a pivotal Phase III study for the treatment of front-line glioblastoma and a Phase II study for the treatment of recurrent glioblastoma; and Glembatumumab vedotin (CDX-011) is a targeted antibody-drug conjugate in a randomized study for the treatment of triple negative breast cancer. The company also has various earlier stage drug candidates in clinical development, including varlilumab (CDX-1127), a fully human therapeutic monoclonal antibody for cancer indications; CDX-301, an immune cell mobilizing agent and dendritic cell growth factor; and CDX-1401, a targeted immunotherapeutic aimed at antigen presenting cells for cancer indications. Its preclinical product candidate includes CDX-014, a human monoclonal antibody-drug conjugate that targets TIM-1, a molecule that is expressed on renal and ovarian cancers with minimal expression in normal tissues. The company has research collaboration and license agreements with Medarex, Inc.; Rockefeller University; Duke University Brain Tumor Cancer Center; Ludwig Institute for Cancer Research; University of Southampton; Amgen Inc.; Amgen Fremont; Seattle Genetics, Inc.; and Bristol-Myers Squibb Company. Celldex Therapeutics, Inc. is headquartered in Hampton, New Jersey.

156 Employees
Last Reported Date: 02/24/15

celldex therapeutics inc (TCE1) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $871.4K
Founder, Chief Scientific Officer and Executi...
Total Annual Compensation: $553.5K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $437.7K
Chief Medical Officer and Executive Vice Pres...
Total Annual Compensation: $589.4K
Chief Business Officer and Senior Vice Presid...
Total Annual Compensation: $411.7K
Compensation as of Fiscal Year 2013.

celldex therapeutics inc (TCE1) Key Developments

Celldex Therapeutics, Inc. Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Year Ended December 31, 2014; Provides Capital Expenditure Guidance for the Full Year 2016

Celldex Therapeutics, Inc. reported unaudited consolidated earnings results for the fourth quarter and year ended December 31, 2014. For the quarter, the company’s total revenue was $1.5 million compared to $0.6 million for the comparable periods in 2013. The increase in the fourth quarter of 2014 was primarily due to the company’s clinical trial collaboration with BMS and the company’s Rockefeller University services agreement. Net loss was $31.8 million, or $0.36 per basic and diluted share, compared to a net loss of $22.1 million, or $0.27 per basic and diluted share for the comparable periods in 2013. Operating loss was $32,051,000 compared to $22,114,000 a year ago. For the twelve months, the company’s total revenue was $3.6 million, compared to $4.1 million for the comparable periods in 2013. The decrease in the twelve months ended December 31, 2014 was primarily due to the decrease in Rotarix royalty revenue. Net loss was $118.1 million, or $1.32 per basic and diluted share, compared to a net loss of $81.6 million, or $1.02 per basic and diluted share for the comparable periods in 2013. Operating loss was $122,430,000 compared to $81,442,000 a year ago. The company provided capital expenditure guidance for the full year 2016. The company expects that its cash, cash equivalents and marketable securities will be sufficient to fund the company’s operating expenses and capital expenditure requirements through 2016, however, this could be impacted by the company’s clinical data results from the Rintega program and their potential impact on the company's pace of commercial manufacturing and the rate of expansion of the company’s commercial operations.

Celldex Therapeutics, Inc. Receives FDA Breakthrough Therapy Designation for the Treatment of Adult Patients with EGFRvIII-Positive Glioblastoma

Celldex Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted rindopepimut (Rintega Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma (GBM). This application was based on data from the Phase 2 ReACT study in recurrent GBM, the Phase 2 ACT III study in newly diagnosed GBM and additional supportive Phase 2 studies. An international Phase 3 study of rindopepimut, called ACT IV, in newly diagnosed GBM completed enrollment (n=745) in December of 2014. Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. Rindopepimut (Rintega) is an investigational immunotherapy that targets the tumor specific oncogene EGFRvIII. Patients with EGFRvIII-positive glioblastoma typically have a worse prognosis than the overall glioblastoma population, including poor long term survival. Rindopepimut (Rintega is an investigational immunotherapy that targets the tumor specific oncogene EGFRvIII (v3), a functional and permanently activated variant of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. Expression of EGFRvIII correlates with increased tumorigenicity in mouse models and poor long term survival in clinical studies of patients with glioblastoma (GBM). In addition, EGFRvIII-positive cells are believed to stimulate proliferation of non-EGFRvIII cells through IL-6 cell-to-cell signaling and to release microvesicles containing EGFRvIII, which can merge with neighboring cells, transferring tumor-promoting activity. EGFRvIII expression may also be associated with tumor stem cells that have been identified in GBM. These stem cells contribute to resistance to cytotoxic therapy and tumor recurrence. EGFRvIII is expressed in tumors in about 30% of patients with GBM. It has not been detected at a significant level in normal tissues; therefore, targeting of this tumor-specific molecule is not likely to impact healthy tissues. Three Phase 2 trials of rindopepimut,ACTIVATE, ACT II, and ACT III, have been completed in newly diagnosed EGFRvIII-positive GBM and have shown consistent improvements in both overall survival and median progression-free survival. The most common adverse events for rindopepimut include injection site reactions, fatigue, rash, nausea and pruritus. Rindopepimut is currently being studied in two clinical trials in EGFRvIII-positive GBM ”an international Phase 3 study called ACT IV in newly diagnosed GBM and a Phase 2 study called ReACT in recurrent GBM.

Celldex Therapeutics, Inc. to Report Q4, 2014 Results on Feb 24, 2015

Celldex Therapeutics, Inc. announced that they will report Q4, 2014 results at 9:00 AM, Eastern Standard Time on Feb 24, 2015


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