Iovance Biotherapeutics (IOVA 0.87%) has been one of the hottest healthcare stocks in 2024. It has already doubled in value and investors are hopeful that there could still be more upside left for the shares now that regulators have approved one of its treatments. Does this stock have the potential to be a millionaire-making investment?

FDA approval marks a turning point for the company

On Feb. 16, the Food and Drug Administration (FDA) granted approval for Amtagvi, which is a cell therapy for unresectable or metastatic melanoma. It is the first T-cell therapy that regulators have approved as a treatment for a solid tumor. Analysts believe Amtagvi's sales could top $846 million by 2029 and it could potentially become a blockbuster drug the following year.

That's a big development for Iovance, which up until now didn't have any approved products. Now the company can begin with the rollout and commercialization of the drug. While that will bring with it additional costs, Iovance will finally generate consistent revenue and be able to grow its top line.

Iovance still has more in its pipeline

Amtagvi's approval is a good start for Iovance, and in the future, there may be many products contributing to the company's sales. Iovance has several ongoing trials in phase 2 or later for non-small cell lung cancer and cervical cancer. The risk for investors, however, is that cancer treatments traditionally have the lowest probabilities of success compared to other therapeutic areas. Meanwhile, the costs of developing treatments is costly and can take years.

The key for Iovance's long-term success will depend on whether it can get more therapies approved. While the approval of Amtagvi is a positive for the business, Iovance will need a lot more for its valuation to skyrocket in the long run.

Another risk investors need to consider

Iovance's finances could start to improve as it launches Amtagvi, but it won't necessarily be a smooth road ahead. The company is still incurring quarterly losses in excess of $100 million. And as it commercializes its newly approved therapy, its expenses could rise. Iovance will need to raise more money, which will likely come through stock offerings.

On Feb. 20, the company announced the pricing of a common stock offering that will raise $211 million for the business. Iovance says that money will be used to help Amtagvi's commercial launch and fund clinical programs. Investors can expect more of these types of offerings in the future as the company invests into research and development. And by offering more shares, that results in dilution for existing shareholders and puts downward pressure on the stock price.

Can Iovance stock help you become a millionaire?

Iovance has the potential to become a much more valuable company in the future. But if you invested $10,000 into the stock, you would need it to grow to 100 times its value for it to make you a millionaire. That would give Iovance a market cap in excess of $460 billion. And it's not getting anywhere near there with just Amtagvi.

There is potential for Iovance shares to generate significant returns, but even some of the top pharma stocks today aren't close to that kind of valuation. For Iovance to reach those levels, it would need to be a truly special company with some high-powered assets in its portfolio. As of now, that just isn't the case. I don't doubt the stock can be a good investment, but investors should be careful to temper their expectations with Iovance, because it still has a long way to go in proving it can be a top growth stock for the long haul.