CRISPR Therapeutics (CRSP 0.34%) may be a few months away from a transformation. The company itself isn't changing, but its financial picture may be about to do so. That's because by year-end, regulators will make a decision about what could become CRISPR's first commercialized product.

CRISPR and big biotech partner Vertex Pharmaceuticals submitted exa-cel, a gene editing candidate for blood disorders, to regulators in the U.S., Europe, and the U.K. And U.S. regulators expect to issue a decision on the candidate for one particular indication -- sickle cell disease -- in December. They aim to decide on exa-cel for beta thalassemia in March.

Meanwhile, CRISPR shares have soared more than 40% since the start of the year. Is now a good time to buy CRISPR -- or is all the good news priced in?

The dream of gene editing

First, let's take a look at this biotech company's progress so far. CRISPR has delighted investors with dreams of gene editing for several years. In fact, the company's stock traded higher in the past -- when there was a lot less visibility on potential earnings to come.

But CRISPR has shown the market that those gene editing dreams may become a reality. The company uses the CRISPR/Cas9 technique of cutting DNA at a particular location and allowing a natural repair process to take place. The idea is, this process can correct faulty genes responsible for genetic disease.

CRISPR uses this technique throughout its pipeline. And an approval of exa-cel would represent a vote of confidence in the potential of the technology. There's reason to be optimistic about upcoming regulatory decisions because clinical trial data has been strong.

In beta thalassemia, nearly 89% of trial participants achieved transfusion independence for at least one year. And in sickle cell disease, more than 94% were free from pain crises associated with the illness for at least 12 months. This means exa-cel met its primary goals in the studies.

This gene editing treatment is expected to bring in more than $1 billion in peak revenue, making it a potential blockbuster. Of course, CRISPR shares profit with Vertex, but this could be just the beginning of a revenue growth story for the company.

Both companies could expand the blood disorders patient group in the coming years because they're testing exa-cel in phase 3 trials in kids. So this could increase the revenue opportunity.

Another potential regulatory submission

Also, CRISPR is approaching the finish line with another candidate. It's testing immuno-oncology candidate CTX-110 in a phase 2 trial that could support a regulatory submission.

CRISPR also has other candidates in the pipeline -- and licenses its gene-editing technology out for others to use. That represents another revenue stream. For example, this spring, Vertex said it would license CRISPR's technology to advance its type 1 diabetes program.

Let's get back to our question: Considering all of this and CRISPR's share-price performance this year, is now a good time to buy this stock?

It's true that some of the exa-cel good news may be priced in. If the U.S. Food and Drug Administration approves exa-cel in December for sickle cell disease, CRISPR shares may not soar. They may not even react.

But that doesn't mean this stock has reached its full potential. Future exa-cel sales aren't necessarily priced in -- and neither are other things to come, such as future approvals of CRISPR's other candidates.

All of this means that investors who buy CRISPR today and hold on for the long term still could win on an investment in this innovative company -- whether the stock responds to upcoming regulatory decisions or not.