This Stock Is Up 58% This Year. Is It too Late to Buy?

One of Intellia Therapeutics' leading candidates recently aced a phase 3 study.

The biotech could see strong returns, but there is ample risk to consider.

Intellia Therapeutics (NASDAQ: NTLA) , a clinical-stage biotech company, did not start the year on a strong note. The company was dealing with regulatory issues: The U.S. Food and Drug Administration had put a pair of its phase 3 studies on clinical hold following the death of a patient from liver damage. However, Intellia Therapeutics was able to overcome that obstacle and resume its late-stage clinical trials. And since then, the company has made even more progress on the clinical front, helping send its stock price much higher. Shares are up 58% year to date. Is it still time to invest in Intellia Therapeutics?

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On April 27, Intellia Therapeutics announced positive results from a phase 3 clinical trial for one of its leading candidates, lonvo-z. This investigational gene-editing medicine targets hereditary angioedema (HAE), a rare genetic condition that causes painful swelling attacks across the body. Although there are standards of care for this condition, there is no permanent cure. The disease, although very rare (it affects about one person in 50,000), places a significant financial burden on patients, their families, and the healthcare system.

Lonvo-z could help address some of those issues as a one-time gene editing treatment for HAE. But is it effective? The phase 3 data Intellia Therapeutics recently released tells us that it is. In the study, patients who received a single infusion of lonvo-z had an 87% reduction in attacks compared with those who received a placebo after about six months of treatment. Further, 62% of patients who received lonvo-z were completely free of attacks, compared with just 11% in the placebo group.

Intellia Therapeutics has begun submitting an application to the FDA for approval of lonvo-z. It plans to launch the medicine in the first half of 2027.

Lonvo-z could become the standard of care in HAE. How much in sales might the medicine generate at its peak? First, note that since it affects one person in 50,000, that means there are roughly 7,000 people in the U.S. who suffer from it. That seems like a small patient population. However, gene editing treatments tend to be expensive. We don't know how much lonvo-z will cost if it earns approval, but it wouldn't be surprising if it goes for several hundred thousand dollars, perhaps even over $1 million. It's also worth noting that lonvo-z is an in vivo gene editing therapy.