Iovance Biotherapeutics (NASDAQ: IOVA) stock jumped after the FDA granted accelerated approval for Amtagvi (lefileucel) as a treatment for advanced melanoma on Friday.
With the stock market closed on Monday due to the Presidents’ Day holiday, investors eagerly awaited Tuesday’s opening to respond to the news, driving Iovance’s share price higher.
In addition to the FDA approval, Iovance announced plans for an underwritten offering on Tuesday morning, intending to issue over 23 million new shares priced at $9.15 each. This move aims to generate gross proceeds of around $211 million, with a portion earmarked to support the commercial launch of Amtagvi.
Significance of FDA approval for Iovance
The significance of the FDA’s approval cannot be overstated for Iovance. With Amtagvi now approved, the company transitions from a clinical-stage biotech to one with a marketable product. Amtagvi stands out as the first individualized T-cell therapy sanctioned by the FDA for treating solid tumors, positioning Iovance at the forefront of innovative cancer treatment.
Iovance is currently conducting late-stage clinical trials of Amtagvi for cervical cancer and non-small cell lung cancer. Analysts at GlobalData forecast that Amtagvi could achieve annual global sales nearing $900 million by 2029.
Iovance Biotherapeutics (NASDAQ: IOVA) Stock Performance
IOVA stock surged 31.48% to close at $12.03 on Tuesday. The traders had exchanged hands with 58,632,276 (58.63 million) shares compared to the average daily trading volume of 7.84 million.
