Tue, Mar. 17, 12:13 PM
- Celldex Therapeutics (CLDX -3.3%) and Roche (OTCQX:RHHBY +0.3%) enter into a clinical trial collaboration to evaluate the combination of Celldex's varlilumab and Roche's MPDL3280A in renal cell carcinoma. Under the terms of the agreement, Roche will provide its drug for the Phase 1/2 study while Celldex will fund and conduct the trial, expected to commence this year.
- Varlilumab (CDX-1127) is a fully human monoclonal antibody that targets CD27, a member of the tumor necrosis factor receptor class. It plays a key role in the activation pathway of lymphocytes and can be effectively manipulated with activating antibodies to induce potent anti-tumor effects while being less toxic due to its restricted expression and regulation.
- MPDL3280A is a monoclonal antibody that inhibits PD-L1 (programmed death-ligand 1), a transmembrane protein that is believed to play a key role in suppressing the immune system by hindering the proliferation of CD8+ T cells, the body's front-line attackers of foreign antigens. Binding to PD-L1 enables the activation of T cells so they can attack and kill cancer cells. The FDA recently designated MPDL3280A a Breakthrough Therapy for PD-L1-positive non-small cell lung cancer.
- Previously: Roche's MPDL3280A a Breakthrough Therapy for NSCLC (Feb. 2)
Thu, Feb. 26, 7:38 AM
- Celldex Therapeutics (NASDAQ:CLDX) prices its public offering opf 7.25M shares of common stock at $24 per share. Underwriters over-allotment is an additional 1,087,500 shares. Closing date is March 3.
- Net proceeds of ~$164.2M will fund the clinical development of its product candidates, expansion of its pipeline, expansion of its commercial team, working capital and general corporate purposes.
Tue, Feb. 24, 7:01 AM
Mon, Feb. 23, 5:30 PM
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Mon, Feb. 23, 12:44 PM
Mon, Feb. 23, 10:22 AM
- Celldex Therapeutics (CLDX +15.2%) jumps on a 50% spike in volume in response to its announcement that the FDA has tagged Rintega (rindopepimut) a Breakthrough Therapy (BTD) for the treatment of adults patients with EGFRvIII-positive glioblastoma (GMB).
- Rindopepimut, currently in Phase 3 development, targets the tumor-specific oncogene, epidermal growth factor (EGFR)vIII, the most common extracellular domain mutation. EGFRvIII-positive GMB patients typically have a worse prognosis and poor long term survival.
- Breakthrough Therapy status provides for more intensive guidance from the FDA review team, the involvement of more senior agency managers and a rolling review of the New Drug Application (NDA) in order to expedite the process.
Mon, Feb. 23, 9:14 AM
Nov. 17, 2014, 12:47 PM
Nov. 17, 2014, 9:15 AM
Nov. 17, 2014, 8:57 AM
- Celldex Therapeutics (NASDAQ:CLDX) is up 20% premarket on robust volume in response to its announcement of interim data from is Phase 2 clinical trial assessing the safety and efficacy of rindopepimut in patients with EGFRvIII-positive glioblastoma (GBM). The results demonstrate signs of clinical activity including groups both naive and refractory to Avastin (bevacizumab) (OTCQX:RHHBY).
- Rindopepimut (Rintega) is an investigational immunotherapy that targets the tumor-specific oncogene EGFRvIII. Patients in this category have a worse prognosis that the overall glioblastoma population and poor long term survival prospects.
- In the bevacizumab-naive group, the primary endpoint is progression-free survival at six months (PFS-6). The value for the rindopepimut arm is 27% compared to 11% in the control arm (p=0.048). Statistically significant overall survival (OS) benefit: rindopepimut median: 12.0 months versus control median of 8.8 months (p=0.0208). Hazard ratio: 0.47.
- In the bevacizumab-refractory group, rare but prominent anti-tumor activity did not meet the hurdle for expanded accrual. Noteworthy OS compared to historical values. Rindopepimut plus bevacizumab was well-tolerated, no serious adverse events attributed to rindopepimut. Early anti-EGFRvIII immune response correlates with survival benefit.
Nov. 14, 2014, 5:38 PM
Nov. 5, 2014, 12:49 PM
Aug. 26, 2014, 12:45 PM
Aug. 6, 2014, 4:15 PM
- Celldex Therapeutics (CLDX -0.4%) Q2 results: Revenue: $592K; Operating Expenses: $29.1M (+55.4%); Operating Loss: ($28.5M) (-52.4%); Net Loss: ($28.3M) (-48.9%); Loss Per Share: ($0.32) (-33.3%); Quick Assets: $252.4M (-16.7%).
- Financial guidance: quick assets on hand should be sufficient to fund operations through 2016.
Aug. 6, 2014, 4:03 PM
Aug. 5, 2014, 5:35 PM
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CLDX vs. ETF Alternatives
Celldex Therapeutics Inc is a biopharmaceutical company. The Company is engaged in the development, manufacturing and commercialization of immunotherapy technologies for the treatment of cancer and other difficult-to-treat diseases.
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