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January 8, 2013
06:32 EDTGTXIFDA designates GTx's enobosarm as Fast Track development program
GTx announced that the FDA has designated enobosarm, or GTx-024, for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer as a Fast Track development program. Fast Track status is a process designed by FDA to facilitate the development and expedite the review of new drug candidates that are intended to treat serious diseases and have the potential to fill an unmet medical need. With a Fast Track designation, there is an increased possibility for a priority review of a new drug application, or, NDA, filed for the drug candidate and more opportunity for more frequent interactions with the FDA both prior to and following the filing of a NDA.
News For GTXI From The Last 14 Days
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October 13, 2015
07:04 EDTGTXIGTx wins FDA clearance to start clinical trial in SUI
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October 6, 2015
07:04 EDTGTXIGTx says first patient enrolled in Phase 2 trial of TNBC treatment
GTx announced the enrollment of the first patient into its Phase 2 clinical trial of enobosarm to treat women with advanced, androgen receptor positive, triple negative breast cancer, or TNBC. Enobosarm is the company's lead product candidate and is also being evaluated in a separate Phase 2 clinical trial to treat estrogen receptor positive, AR+ breast cancer, which the company recently announced had also enrolled its first patient. The open-label, multi-center, multinational Phase 2 clinical trial will evaluate the efficacy and safety of orally administered enobosarm in up to 55 women with advanced, AR+ TNBC. Patients will receive 18 mg of enobosarm once daily for up to 12 months. The initial stage will be assessed among the first 21 evaluable patients. If at least 2 of 21 patients achieve clinical benefit at week 16, then the trial will proceed to the second stage of enrollment of up to a total of 41 evaluable patients. Clinical benefit is defined as a complete response, partial response, or stable disease, as measured by Response Evaluation Criteria in Solid Tumors at 16 weeks. The trial, which is being conducted under the leadership of Dr. Hope Rugo from the University of California at San Francisco, will include investigators from more than 40 clinical trial sites in the U.S. and abroad.
September 29, 2015
07:02 EDTGTXIGTx announces enrollment of first patient in Phase 2 Enobosarm trial
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