Advaxis (ADXS) Stock Heads For The Top On FDA Clearance

Advaxis ADXS Stock News

Advaxis, Inc. (NASDAQ: ADXS) is running for the top in the market this morning and for good reason. The company announced that it has received clearance for an IND application. Here’s what’s going on:

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ADXS Stock Climbs On IND Clearance

In the press release, Advaxis announced that the FDA has cleared its Investigational New Drug application for the initiation of a Phase 1 clinical study. The study will center around the company’s ADXS-504 candidate as a potential option for patients with prostate cancer.

In the release ADXS reminded investors that this IND clearance comes in addition to the sponsored IND that was announced in January of this year.

The company said that moving forward, it intends on advancing the clinical evaluation of ADXS-504 through an Investigator Sponsored Phase 1 study in prostate cancer patients with biochemical recurrence. This study remains on track for initiation in the fourth quarter of 2020.

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

We are excited to announce the transition of our ADXS-504 HOT prostate program to an investigator sponsored study at this time. By partnering with a prestigious academic medical center, we would be gaining access to world-class expertise and a high volume of patients that together, may expedite both enrollment and eventual study results. This strategic decision also conserves resources which can be leveraged to support our encouraging and expanding HOT program in NSCLC. Our data generated to date with ADXS-503 in NSCLC leave us increasingly confident that our off-the-shelf neoantigen program can provide well-tolerated treatments with robust innate and adaptive immune responses and potential clinical activity. We look forward to the initiation of this Phase 1 study with ADXS-504 monotherapy in patients with prostate cancer before year end.

This Is Big News

The news released by Advaxis this morning proved to be overwhelmingly positive. The fact that the IND was approved means that there isn’t just 1, but 2 likely clinical programs ahead for ADXS-504 as a potential option in prostate cancer.

This opens the door to several catalysts to look forward to ahead. Moreover the prostate cancer market is a huge one. In 2026, it’s expected that the market will grow to be worth more than $9.9 billion.

Keep in mind we’re talking about a company with a market cap of just over $25 million. Considering the sheer size of the market and the fact that the company is moving forward with clinical trials, ADXS stock represents a large potential opportunity.

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