What happened

Shares of the small-cap immunotherapy company Agenus (NASDAQ:AGEN) were up by a healthy 9.98% as of 11:08 a.m. EDT Thursday morning. The biotech's stock is rising today in response to the Food and Drug Administration's acceptance of the company's Biologics License Application (BLA) for balstilimab.

Balstilimab is an anti-PD-1 antibody indicated for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The FDA reportedly set a target action date of Dec. 16, 2021, for the experimental cancer treatment.

Close up image of cancer cells.

A close-up of cancer cells. Image source: Getty Images.

So what

An approval would arguably go a long way toward validating Agenus' long and winding pivot to cancer treatments as its main value driver. What's important to understand is that the company started down this road over seven years ago, and this BLA marks Agenus' first regulatory filing from this effort.

Moreover, Wall Street has never loved this strategy due to the fact that the checkpoint inhibitor space is a tough place to make a living, given the intense level of competition. Balstilimab's upcoming regulatory review, though, could be the catalyst that finally changes the narrative around the company's cancer-treatment pipeline, as well as its stock. 

Now what

Can Agenus' shares push even higher? That's a definite yes for a multitude of reasons.

Apart from the maturation of its cancer-treatment pipeline, Agenus recently inked a lucrative development deal with Bristol Myers Squibb. This sizable deal could prove to be a prelude to a buyout.

What's more, the company has multiple clinical and regulatory catalysts coming up over the next year. Aggressive investors, therefore, might want to check out this intriguing biotech growth stock soon. 


This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.