Vertex Pharmaceuticals (NASDAQ: VRTX) is heading toward a big moment: a regulatory decision on what may become its next game-changing product. And this potential product, exa-cel for blood disorders, is outside of Vertex's specialty area of cystic fibrosis (CF). Investors previously worried about Vertex's ability to expand beyond CF, so a nod here could be big.

The stock has reflected this excitement. Vertex shares have climbed more than 20% so far this year. Now, as we head into the second half of the year, we may wonder if Vertex can keep up the pace. Should we be bearish or bullish on this billion-dollar biotech company? Let's consider both cases.

As mentioned above, Vertex shares already have advanced quite a bit. Some of the excitement about exa-cel may be priced in. This means that until the regulatory decisions -- one in December and one in March -- the shares may not move significantly higher. The U.S. Food and Drug Administration granted Vertex priority review for sickle cell disease, speeding up the review time to Dec. 8. Regulators will decide on exa-cel for beta thalassemia on March 30 of next year.

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Source Fool.com