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March 25, 2014
07:09 EDTEXELExelixis announces Cometriq approved in Europe
Exelixis announced that the European Commission has approved Cometriq for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma, or MTC. The European Commission granted conditional marketing authorisation following a positive opinion from the European Committee for Medicinal Products for Human Use, or CHMP, issued in December 2013. Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions. The Committee for Orphan Medicinal Products also reviewed the designation for Cometriq as an orphan medicinal product for the treatment of MTC, and recommended maintenance of orphan drug designation at the time of marketing authorisation.
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September 1, 2014
18:19 EDTEXELExelixis announces 70% workforce reduction after trial failure
Exelixis said that as a result of the outcome of COMET-1, it will initiate a "significant" workforce reduction to enable the company to focus its financial resources on the late-stage clinical trials of cabozantinib in metastatic renal cell carcinoma and advanced hepatocellular carcinoma. The company will reduce its workforce by approximately 70%, or approximately 160 employees, resulting in approximately 70 remaining employees. Exelixis anticipates the one-time restructuring charge associated with the workforce reduction to be approximately $6M-$8M, with the majority to be completed by the end of Q4. As a result of this and other cost-saving measures contemplated, the company anticipates that it has sufficient cash to support its operations through the release of top-line results of the METEOR trial next year.
18:17 EDTEXELExelixis says COMET-1 phase 3 trial did not meet endpoint
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