Advaxis, Inc. (NASDAQ: ADXS) is having a great start to the trading session this morning after news that the FDA has lifted a clinical hold hit the tape. Of course, the news was overwhelmingly positive, exciting investors who are sending the stock screaming for the top. Today, we’ll talk about:
- The lifted hold;
- what we’re seeing from ADXS as a result; and
- what we’ll be watching for ahead.
ADXS Announces Lifted Clinical Hold
As mentioned above, Adaxis is having an incredibly strong start to the trading session this morning after announcing news from the United States Food and Drug Administration (FDA). In a press release issued early this morning, the company announced that the FDA has lifted a clinical hold on the company’s Investigational New Drug application for its Phase 1/2 study. The study is assessing the axalimogene filolisbac (AXAL) in combination with durvalumab for the treatment of advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer.
In the release, ADXS reminded investors that the clinical hold was issued on March 9th following the submission of a safety report to the FDA surrounding a patient death that occured post-dosing and involved acute respiratory failure after nin months of combination therapy. In the release, ADXS said that new guidelines for early detection and treatment of these rare events were agreed to with the FDA and will be implemented into the study. As a result, the hold has been lifted. In the release, the company said that other clinical programs surrounding durvalumab were not affected by the hold. In a press release, Kenneth A. Berlin, President and CEO at ADXS, had the following to offer:
We are pleased to have resolved this issue with the FDA and will implement these guidelines across Advaxis’ portfolio as needed, to ensure patient safety. We remain confident in the safety of axalimogene filolisbac based on our experience in treating approximately 400 patients and more than 1200 doses across multiple trials in HPV-associated cancers.
What We’re Seeing From The Stock
As investors, we know that the news moves the market. In the case of Adaxis, the news proved to be overwhelmingly positive. After all, the lifted hold means that the company now has the ability to continue forward with the clinical trial. Of course, that’s going to excite investors. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:28), ADXS is trading at $1.44 per share after a gain of $0.21 per share or 17.62% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on ADXS. In particular, we’re interested in following the story surrounding the company’s continued work with regard to the clinical trial that can now proceed. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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