Advaxis (ADXS) Stock Rockets On FDA Clearance

Advaxis ADXS Stock News

Advaxis, Inc. (NASDAQ: ADXS) is having a great start to the trading session this morning, gaining more than 19% early on. The gains come after the company said that it has received clearance from the FDA.

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ADXS Announces FDA Clearance

In a press release issued early this morning, Advaxis said that the United States Food and Drug Administration has cleared the Investigational New Drug application for the initiation of a Phase 1 clinical study.

In the study, ADXS will assess ADXS-504, its ADXS-HOT candidate under development for the treatment of prostate cancer. In the release, the company reminded investors that its ADXS-HOT is its off-the-shelf neoantigen clinical program targeting hotspot mutations.

At the moment, these hot spot mutations include more than ten cancer-type specific drug constructs in various stages of development.

In a statement, Kenneth A. Berlin, President and CEO at ADXS, had the following to offer:

With encouraging proof-of-concept data within our neoantigen program, we believe the ADXS-HOT program has potential to provide off-the-shelf, neoantigen targeted immunotherapies to a broad patient population. We are proud of the progress we have made to date with our HOT program, which includes advancing the clinical development of ADXS-503, our candidate for non-small cell lung cancer, while also seeking to launch our next clinical program, ADXS-504, in prostate cancer. We look forward to presenting immunogenicity and safety data from the first cohort from our lung program later this quarter.

Why Investors Are So Excited

First and foremost, the key term in clinical-stage biotechnology stocks is “clinic.” Any time a publicly traded biotechnology company in this stage brings a new drug to the clinic, it’s an exciting move. After all, should all go well in trials, there will be several positive catalysts to look forward to.

However, the excitement goes far beyond the fact that a single drug is entering the clinic. The ADXS-HOT program at Advaxis is one that has had investors on the edges of their seats. As mentioned above, there are more than 10 drugs across various stages of development that have been created as a result of the program.

Should all go well in any of these drugs, it will be an indication that all drugs in the program will generate similar results. As these drugs continue to find their way to and through development, the intrinsic value of the company is likely to grow.

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