Company Update (NASDAQ:ADXS): FDA Lifts Advaxis, Inc. Clinical Hold

Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on all of the company’s Investigational New Drug (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.

“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,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.

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. Following discussions with the FDA and in accordance with their recommendations, the company agreed to implement certain risk mitigation measures, including revised study protocol inclusion / exclusion criteria, post-administration antibiotic treatment and patient surveillance and monitoring measures. (Original Source)

In light of the news, shares of Advaxis are up 39.76% to $11.60. ADXS has a 1-year high of $30.13 and a 1-year low of $4.12. The stock’s 50-day moving average is $11.90 and its 200-day moving average is $15.44.

On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on October 5, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on ADXS, with a price target of $30, which implies an upside of 261.4% from current levels. Separately, on September 14, FBR’s Vernon Bernardino maintained a Buy rating on the stock .

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Swayampakula Ramakanth and Vernon Bernardino have a total average return of -23.4% and -26.3% respectively. Ramakanth has a success rate of 15.8% and is ranked #3597 out of 3632 analysts, while Bernardino has a success rate of 16.7% and is ranked #3620.

Advaxis Inc is a clinical development stage biotechnology company. The company is engaged in developing safe & effective immunotherapies for cancer & infectious diseases.


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