Shares of Iovance Biotherapeutics (IOVA 0.87%) had skyrocketed by 33.8% as of 10:39 a.m. ET Tuesday. The huge gain came after the company announced on Friday that the Food and Drug Administration (FDA) had granted accelerated approval for Amtagvi (lefileucel) as a treatment for advanced melanoma.
Because of the Presidents' Day holiday, the stock market was closed on Monday. Investors had to wait until Tuesday to push Iovance's share price higher.
Iovance also announced on Tuesday morning the pricing of an underwritten offering to issue just over 23 million new shares for $9.15 per share. That stock sale will generate gross proceeds of around $211 million. Part of the money will be used to support the commercial launch of Amtagvi.
How big is the FDA approval for Iovance?
It's hard to overstate just how important the FDA's approval of Amtagvi is for Iovance. The company is no longer a clinical-stage biotech -- it now has a marketable product. And not just any product: Amtagvi is the first (and so far, only) individualized T-cell therapy to win a thumbs-up from the FDA to treat a solid tumor.
Iovance is also evaluating Amtagvi in late-stage clinical studies targeting cervical cancer and non-small cell lung cancer. Analytics company GlobalData projects that Amtagvi will generate annual global sales of nearly $900 million by 2029.
Is Iovance Biotherapeutics stock a good pick to buy now?
With a market cap of nearly $3.2 billion, much of the anticipated growth for Iovance is already priced into the stock. However, the company could still have more catalysts on the way, including potential regulatory approvals for Amtagvi in other countries. I think Iovance stock remains a good pick to buy for aggressive investors.
