Genprex (GNPX) Stock Rockets On Fast Track Designation

Genprex GNPX Stock News

Genprex Inc (NASDAQ: GNPX) is rocketing in the market this morning, trading on more than 280% gains. The gains come after the company announced that it has received fast track designation, triggering a short squeeze.

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GNPX Stock Squeezes Shorts On FDA Fast Track Announcement

Genprex issued a press release this morning, announcing that the FDA has handed down Fast Track Designation. The designation surrounds the company’s Oncoprex immunogene therapy in combination with EGFR inhibitor Tagrisso by AstraZeneca (NYSE: AZN).

At the moment, the combination treatment is being assess as a potential option for patients with non-small cell lung cancer patients with EFGR mutations that progressed after treatment with osimertinib alone.

GNPX reminded investors that Oncoprex is made up of the TUSC2 gene complexed with a lipid nanoparticle. The immuno-oncology candidate is expected to change the tumor microenvironment with the goal of making Tagrisso and other anti-tumor agents more effective.

To date, Oncoprex has been used to treat more than 50 lung cancer patients in both Phase 1 and Phase 2 clinical trials. GNPX has released promising results in these cases, suggesting that the drug will have strong efficacy and safety profiles when combined with Tagrisso.

In a statement, Rodney Varner, Chairman and CEO at GNPX, had the following to offer:

Genprex is excited to receive this important FDA designation. In addition to potentially facilitating and expediting our pathway to approval, we believe that this FDA designation validates our plan to commercialize Oncoprex immunogene therapy in combination with EGFR inhibitors for the treatment of lung cancer. We hope that Fast Track Designation helps us bring our gene therapy to patients more rapidly and that our unique gene therapy platform is more widely recognized for its potential in cancer treatment.

The fast track designation led to quite a bit of excitement on a heavily-shorted stock, creating an opportunity. When the stock started to move up, shorts had to race to cover their positions, buying more stock, increasing volume and increasing price in what is known as a short squeeze!

This Is Big News For Genprex

FDA Fast Track Designation is a big deal. First and foremost, it shortens the length of the road from development to potential approval. On top of that, the FDA is more involved in the development of the treatment, leading to a stronger potential for approval.

In order to gain Fast Track Designation, drugs must show distinct advantages over other options in serious conditions. At the same time, these drugs must avoid serious side effects and improve outcomes for patients.

So, the Fast Track Designation will help GNPX bring this Oncoprex combination to market. Should this be the case, the drug has the potential to become a blockbuster. After all, Tagrisso generated $2.31 billion in revenue for AZN in the first 9 months of 2019. Should Oncoprex tap into even a small portion of that market, it would be huge for GNPX, a stock with a market cap under $30 million.

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