Advaxis Skyrockets on Resumed Clinical Trials

Advaxis Inc. (NASDAQ: ADXS) was absolutely running away early in Wednesday’s regular session on the release of an U.S. Food and Drug Administration (FDA) restriction. The company announced that the FDA has lifted the clinical hold on all of the company’s Investigational New Drug (IND) applications for its three product candidates: axalimogene filolisbac, ADXS-PSA and ADXS-HER2.

As a result, the company will resume all clinical trials for the aforementioned candidates.

Advaxis received notification from the FDA in October 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.

Following discussions with the FDA and in accordance with their recommendations, Advaxis agreed to implement certain risk-mitigation measures, including revised study protocol inclusion/exclusion criteria, post-administration antibiotic treatment and patient surveillance and monitoring measures.
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Daniel J. O’Connor, president and CEO of Advaxis, commented:

We appreciate the FDA’s review of this matter. We are grateful that our clinical trials will now resume so that we may continue investigating new treatments for unmet medical needs. We thank both the patients and their physicians for their participation in our clinical trials.

Advaxis has outperformed the market so far in 2015, with its shares up over 3%. Over the past 52 weeks, the stock is up roughly 90%.

Shares of Advaxis were trading up more than 33% at $11.11, with a consensus analyst price target of $29.50 and a 52-week trading range of $4.37 to $30.13.