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June 10, 2014
06:32 EDTADXSAdvaxis says End-of-Phase 2 meeting with FDA has been granted to review ADXS-HPV
Advaxis announced that its request for an End-of-Phase 2 meeting with the FDA has been granted. The purpose of the EOP2 meeting with FDA is to review clinical findings to date of Advaxis's immunotherapy product candidate, ADXS-HPV, in order to assess any additional information needed prior to moving ADXS-HPV forward with the next phase of its clinical development. The meeting will establish a dialogue with FDA on ADXS-HPV during which Advaxis can obtain agency recommendations and feedback on the next steps it needs to take in investigating this important immunotherapy product candidate. Advaxis plans to prepare and provide FDA with a comprehensive package detailing its investigational invasive cervical cancer therapy, its phase 1 and 2 clinical findings, its CMC strategy and the Company's plans for a pivotal phase 3 program.
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August 26, 2015
08:05 EDTADXSAdvaxis enters licensing agreement with Knight Therapeutics
Advaxis announced that the company has entered into a licensing agreement with Knight Therapeutics to commercialize in Canada Advaxis's product portfolio including its three lead drug candidates: axalimogene filolisbac for human papilloma virus, or HPV,-associated cancers, ADXS-PSA for prostate cancer and ADXS-HER2 for HER2 expressing solid tumors. In connection with the licensing agreement, Knight is purchasing directly from Advaxis 359,454 shares at $13.91 per share, which represents a 7% premium to the price of Advaxis's common stock at market close on August 25. In addition, Sectoral Asset Management, a leading Canadian-based global healthcare investment advisor, is purchasing 1.44M shares at $13.91 per share directly from Advaxis on behalf of its clients. The combined gross proceeds to Advaxis from these direct investments is $25M.
August 20, 2015
09:23 EDTADXSAdvaxis, MedImmune begin enrollment in axalimogene filolisbac Phase I/II study
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