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High-Conviction Regulatory Designations Prove the Point for Aravive (ARAV)

Aravive’s cancer-fighting therapy is targeted, transformative, and fast-tracked for success 

A number of deadly and difficult-to-treat diseases, including cancer and fibrosis, share a common underlying characteristic: the overgrowth of abnormal cells, which migrate and invade healthy tissues.

It’s a major challenge for the medical community, but it’s also an opportunity for Aravive, Inc. (ARAV) to step up to the plate. Aravive’s is a biotechnology company principally situated in Houston, Texas, where it relocated after receiving a $20 million Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016.

Aravive is focused on developing novel therapies to address the unmet medical needs of cancer patients. With an addressable market opportunity of 106,000 patients and major expansion potential, Aravive stands apart from other oncology-focused biotech firms.

Moreover, the company has earned crucial designations from more than one regulatory entity – significant steppingstones on the pathway to life-changing success for all of Aravive’s stakeholders.

A Closer Look at ARAV Stock

If you can catch ARAV stock at the right time, you may be setting yourself up for robust returns in a surprisingly short period of time.

History has shown this to be true. For instance, in February and March of 2021, ARAV stock jumped from around $5 to $9.95, practically doubling the investment of well-timed shareholders.

And as they say, history often repeats itself. In the middle of December, ARAV stock was trading at a major discount, at just $2.65.

If anyone liked the stock at $5, then they should absolutely love it at half that price. After all, biotech stocks are typically capable of swift price moves – especially when regulators give the company the green light to advance their clinical research.

A Truly Novel Approach

One feature that scientists have detected in certain forms of hard-to-treat cancer is activation of the GAS6/AXL signaling pathway. This is known to cause tumor invasion and metastasis, and high levels of GAS6 and AXL have been strongly associated with drug resistance, rapid disease progression, and lower survival.

Unfortunately, the currently prevalent attempts to target this important pathway have fallen short, causing either undesirable off-target effects or limited efficacy.

To circumvent these challenges, Aravive is taking an entirely novel approach: targeting the GAS6 ligand, rather than the AXL protein.

Aravive’s lead product candidate, batiraxcept (formerly known as AVB-500), is an ultra-high affinity decoy protein that captures GAS6, thereby potentially stopping the migration and invasion of tumor cells into healthy tissue.

In pre-clinical studies, batiraxcept has been shown to suppress serum GAS6 to undetectable levels, and correspondingly decrease metastatic disease. Plus, analysis of all safety data to date has shown that batiraxcept has been generally well tolerated with no dose-limiting toxicities or unexpected safety signals.

Getting on the Fast Track

Not only is it entirely unique, but batiraxcept has multiple potential cancer-fighting applications.

Three of the most promising applications for batiraxcept right now include:

  • Platinum Resistant Ovarian Cancer: Ovarian cancer ranks fifth in cancer deaths among women, and it is estimated that there will be approximately 21,410 new cases of ovarian cancer in the United States in 2021. Aravive has initiated a registrational Phase 3 trial of batiraxcept in platinum resistant ovarian cancer.
  • Clear Cell Renal Cell Carcinoma: It is estimated that there will be approximately 76,080 new cases of kidney cancer and 13,780 people will die from this disease in the United States in 2021. Clear cell renal cell carcinoma is a cancer of the kidney and accounts for more than 75% of malignant kidney tumors. Aravive has initiated a Phase 1b/2 clinical trial of batiraxcept in patients with clear cell renal cell carcinoma. 
  • Pancreatic Adenocarcinoma: Tragically, Pancreatic cancer is projected to become the third leading cause of cancer death worldwide by 2025. Pancreatic adenocarcinoma is the most common type of pancreatic cancer, and Aravive has initiated a Phase 1b/2 clinical trial of batiraxcept in patients with pancreatic adenocarcinoma.

It’s not every day that you’ll find such a widely applicable cancer-fighting treatment candidate.

And here’s a potentially game-changing development: batiraxcept has been granted Fast Track designation by the U.S. Food and Drug Administration, as well as orphan drug designation by the European Commission in platinum resistant recurrent ovarian cancer.

The Bottom Line

Clearly, earning these designations proves that batiraxcept is science-backed and favored by regulators on multiple continents.

Given those green-light designations from regulators in the U.S. and Europe, it’s surprising that ARAV stock is as cheap as it currently is.

That’s not a problem, but only an opportunity for enterprising investors to stake their claim in Aravive before the share price makes its next move to the upside.

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