Last $18.89 USD
Change Today +0.0743 / 0.39%
Volume 335.3K
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As of 9:53 AM 12/19/14 All times are local (Market data is delayed by at least 15 minutes).

celldex therapeutics inc (CLDX) Snapshot

Open
$18.78
Previous Close
$18.11
Day High
$19.20
Day Low
$18.59
52 Week High
02/24/14 - $33.33
52 Week Low
05/9/14 - $10.76
Market Cap
1.7B
Average Volume 10 Days
2.1M
EPS TTM
$-1.23
Shares Outstanding
89.6M
EX-Date
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P/E TM
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Dividend
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Dividend Yield
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Current Stock Chart for CELLDEX THERAPEUTICS INC (CLDX)

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celldex therapeutics inc (CLDX) 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.

120 Employees
Last Reported Date: 03/3/14

celldex therapeutics inc (CLDX) 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 (CLDX) Key Developments

Celldex Therapeutics, Inc. Announces Completion of Enrollment in Phase 3 Study of Rindopepimut in Frontline Glioblastoma

Celldex Therapeutics, Inc. announced that patient enrollment has been completed in the Company's Phase 3 ACT IV study of rindopepimut in EGFRvIII positive glioblastoma, an aggressive form of brain cancer. The ACT IV study is a randomized, double-blind, placebo controlled study of rindopepimut plus GM-CSF added to standard of care temozolomide in patients with newly diagnosed, surgically resected, EGFRvIII-positive glioblastoma. In total, over 4,800 patients were screened for EGFRvIII status from more than 200 clinical trial sites across 22 countries and, consistent with prior studies, 30% were positive for the EGFRvIII mutation. 745 patients were enrolled into ACT IV to reach the required 374 patients with minimal residual disease (assessed by central review) needed for analysis of the primary overall survival endpoint. All patients, including patients with disease that exceed this threshold, will be included in a secondary analysis of overall survival as well as analyses of progression-free survival, safety and tolerability, and quality of life. The timing of the overall survival primary endpoint data is event-driven. Interim analyses will be conducted by an independent Data Safety and Monitoring Board at 50 and 75% of events. The first interim analysis is expected in mid-2015 and will provide insight into the frequency of events to inform estimates regarding timing for the second interim and final data read out. The ACT IV study was designed with formal input from both the United States Food and Drug Administration and the European Medicines Agency. Rindopepimut has received Fast Track Designation in the United States and Orphan Drug Designation in both the United States and the European Union.

Celldex Therapeutics, Inc. Announces Phase 2 Study of Glembatumumab Vedotin in Patients with Advanced Melanoma

Celldex Therapeutics, Inc. announced that it has initiated an open-label Phase 2 study of glembatumumab vedotin (CDX-011) in patients with unresectable Stage III or IV melanoma. Glembatumumab vedotin is a fully-human monoclonal antibody-drug conjugate (ADC) that targets glycoprotein NMB (gpNMB), a protein overexpressed by multiple tumor types, including metastatic melanoma where approximately 85% of patients overexpress the marker. Overexpression of gpNMB has been shown to promote the invasion and metastasis of cancer and has been associated with poor clinical outcome. The study is expected to include up to 10 sites in the United States and will enroll approximately 60 patients. Glembatumumab vedotin was previously evaluated in a Phase 1/2 study in patients with unresectable stage III or stage IV melanoma, a Phase 1/2 study in advanced breast cancer, a Phase 2 study in advanced breast cancer (the EMERGE study) and is currently being evaluated in patients with metastatic triple negative breast cancers that overexpress gpNMB in the METRIC Study. This study is a Phase 2, open-label study of glembatumumab vedotin in patients with unresectable stage III or IV melanoma. Eligible patients must have received no more than four prior anticancer regimens, including no more than one prior chemotherapy-containing regimen, for advanced disease. Patients will receive glembatumumab vedotin every 3 weeks until disease progression or intolerance and then be followed for survival. Prior treatments must include ipilimumab and BRAF/MEK targeted agents, as applicable. The primary objective is to evaluate the anticancer activity of glembatumumab vedotin in advanced melanoma as measured by the objective response rate (ORR). Secondary endpoints include analyses of progression-free survival (PFS), duration of response (DOR), overall survival (OS), retrospective investigation of whether the anticancer activity of glembatumumab vedotin is dependent upon the degree of gpNMB expression in tumor tissue and safety.

Celldex Therapeutics, Inc. Provides Interim Update from Randomized Phase 2 ReAct Study of Rindopepimut in Recurrent Bevacizumab-Naive Glioblastoma Demonstrates Statistically Significant Survival Benefit

Celldex Therapeutics, Inc. announced an interim update from the Phase 2 ReACT study of rindopepimut in EGFRvIII-positive glioblastoma (GBM). The ReACT results demonstrate clear signs of clinical activity in patients with recurrent glioblastoma, including groups both naïve and refractory to bevacizumab (Avastin(R)). Rindopepimut (RINTEGA(R)) 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. Group 1 - Recurrent GBM; bevacizumab (bev) naïve (randomized: rindo + bev vs. control + bev): Primary endpoint of PFS-6 (% alive without progression at 6 months)--rindopepimut 27% vs. control 11%; p=0.048. Statistically significant overall survival benefit--hazard ratio of 0.47; p=0.0208; rindopepimut median 12.0 months vs. control median 8.8 months. An increase in clinically meaningful tumor shrinkage. Rindopepimut plus bevacizumab was well tolerated; no serious adverse events attributed to rindopepimut. Early anti-EGFRvIII immune response correlates with survival benefit Group 2/2C - Recurrent GBM; bev refractory (single arm: rindo + bev). Rare, but prominent anti-tumor activity did not meet high hurdle for expanded accrual of Group 2C. Noteworthy overall survival compared to historical comparisons. Rindopepimut plus bevacizumab was well tolerated; no serious adverse events attributed to rindopepimut. Early anti-EGFRvIII immune response correlates with survival benefit. ReACT is a Phase 2 exploratory study designed to determine if adding rindopepimut to standard of care bevacizumab improves the outcomes for patients with EGFRvIII-positive recurrent glioblastoma across multiple measures. The study includes 3 groups: Group 1 - bevacizumab naive, n=72, patients randomized to receive either rindopepimut or Keyhole Limpet Hemocyanin (KLH) (administered as a control), each along with bevacizumab. Group 2 - bevacizumab refractory (defined as having progressed/grown through bevacizumab by RANO criteria within two months of prior bev treatment), n=25, patients receive rindopepimut plus bevacizumab in a single treatment arm. Group 2C (C = Confirmatory) - bevacizumab refractory expansion, n=up to 75 (Simon two-stage design; 1st cohort n=28), patients receive rindopepimut plus bevacizumab in a single treatment arm.

 

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