16.12.2015 15:24:50
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FDA Lifts Advaxis Clinical Hold; Stock Surges - Quick Facts
(RTTNews) - Advaxis Inc.(ADXS) said that the U.S. Food and Drug Administration has lifted the clinical hold on all of the company's Investigational New Drug or IND applications for its three product candidates: axalimogene filolisbac (formerly ADXS-HPV), ADXS-PSA and ADXS-HER2.
Advaxis will therefore resume all clinical trials with axalimogene filolisbac, ADXS-PSA and ADXS-HER2.
In Wednesday's pre-market trading, ADXS shares are Up $3.08 or 37.11% to $11.38.
In October of 2015, Advaxis received notification from the FDA that its IND applications for axalimogene filolisbac were put on clinical hold in response to the company's submission of a safety report to the FDA. The clinical hold also included the INDs for ADXS-PSA and ADXS-HER2.
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