CRISPR Therapeutics (CRSP +3.45%) is a company that doesn't have an approved product on the market. Its operations are unprofitable, and it is burning through cash. There are many reasons that this may look like a risky, dangerous stock to own. But there's a potential catalyst waiting in the company's not-too-distant future that could send the stock soaring. And it could happen as early as next month.
Decision day is coming soon
The big news for CRISPR is whether the Food and Drug Administration (FDA) will approve the gene-editing therapy exa-cel that it has been developing with Vertex Pharmaceuticals. The key date for investors to circle is Dec. 8, its PDUFA date. That's the final day for the FDA to make a decision by, and approve or not approve exa-cel to treat people with sickle cell disease. And that's just one of the possible indications for the therapy. The other is transfusion-dependent beta-thalassemia. The PDUFA date to treat that condition is March 30, 2024.
Although investors won't know the status of both indications until well into next year, if exa-cel obtains approval for sickle cell disease, it would be sure to generate significant interest and excitement in the stock next moth. And more importantly, it would improve the company's growth prospects. It will share in the profits on exa-cel with Vertex, and the margins could be massive.
NASDAQ: CRSP
Key Data Points
A cost-effective treatment even at $2 million
Margins could look fantastic on exa-cel. Experts believe the therapy may provide so much value to patients that even at a high price tag it would still be cost effective. Exa-cel is a functional cure for sickle cell disease, and it can prevent the need for ongoing treatment. It has the potential to be a life-changing therapy for people with the disease, which is why a high price tag could be justifiable.
In July, the Institute for Clinical and Economic Review said that even at $2.05 million the treatment could be cost effective. That doesn't mean Vertex and CRISPR will price the treatment that high, but it does suggest there could be support for a high price, making it easier for the companies to benefit from a fairly strong profit margin on exa-cel.
Losses continue for now, but that could change
The big risk with CRISPR Therapeutics is that the business doesn't have an approved product, and that means its losses remain substantial. Over the course of the first two quarters of 2023, CRISPR incurred a net loss of $131 million -- down from a loss of $365 million a year ago (due to a combination of lower costs and higher collaboration revenue).
So CRISPR still means that the business can make for a risky investment. However, the approval of exa-cel would certainly change that, and give CRISPR a way to strengthen its bottom line.
Is CRISPR Therapeutics stock a buy?
CRISPR Therapeutics stock has a market cap of $4.2 billion, which doesn't seem terribly high for a company that could be on the cusp of an approval for an expensive, life-changing treatment . This year the stock has been up and down, but overall CRISPR's shares have risen by more than 30% -- but that's after falling 46% last year.
It has been a bumpy ride for investors, but with an approval potentially coming soon for at least one indication, the healthcare stock could be due to achieve even greater gains in the near future. If you're OK with taking on some risk, CRISPR Therapeutics could be one of the best growth stocks to buy right now.
