NEW YORK, NY / ACCESSWIRE / April 17, 2018 / Shares of Celldex fell to record lows on Monday after its triple negative breast cancer drug candidate didn't meet endpoints in a phase 2b trial. The company also decided to discontinue the drug candidate across all indications. Shares of Cancer Genetics were having a much better day, closing up nearly 40% after receiving special 510(k) clearance from the FDA for its Tissue of Origin (TOO) Test.
RDI Initiates Coverage on:
Celldex Therapeutics, Inc.
Cancer Genetics, Inc.
Celldex Therapeutics, Inc. shares tumbled yesterday on heavy volume to see a steep loss of 64.60% at Monday's close. Shares had already dropped over 40% in pre-market trading after it was revealed that the company's triple negative breast cancer drug candidate, glembatumumab vedotin ( glemba), had failed to meet its primary end point in a phase 2b trial. The company said there was also no significant advantage for glembatumumab vedotin in key secondary endpoints. Investors were discouraged to learn that the company has decided to discontinue the glembatumumab vedotin program across all indications. Celldex is now "prioritizing" its pipeline and the company's CEO Anthony Marucci remarked, "In line with this, we are evaluating our operational and workforce needs to extend our financial resources and direct them to continued pipeline advancement. Once we solidify these plans, we intend to update investors."
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Cancer Genetics, Inc. shares closed up 38.22% on Monday and continued to see gains in after-hours trading after the company had some positive FDA news. Cancer Genetics announced in a press release yesterday that it has received special 510(k) clearance from the U. S. Food and Drug Administration (FDA) for its Tissue of Origin test (TOO®) following modifications made to test reagents and software. The oncology company's TOO® is a microarray-based gene expression test that analyzes a tumor's genomic information to help identify its origin. This is valuable in classifying metastatic, poorly differentiated, or undifferentiated cancers. COO of the company and Interim CEO, John a. Roberts, remarked, "Our TOO® Test represents a unique offering with the ability to add significant value to the continuum of care for cancer patients and greatly enhance our biopharma partners' development efforts. This 510(k) clearance represents an important milestone toward our goal of gaining broad adoption of the test. An important element of our recently implemented transformation strategy is the identification of new methods through which to monetize our world-class test portfolio. We are currently evaluating several partnering opportunities that would expand the reach of the TOO® Test and have the potential to generate high-margin revenue streams. We look forward to continuing this process as we leverage the capabilities of TOO® to drive future growth."
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