What happened
Shares of Iovance Biotherapeutics (NASDAQ: IOVA) were up more than 16% as of noon ET on Monday. The biotech stock is down more than 42% so far this year, but is up more than 30% over Thursday’s closing price.
So what
There are a couple of reasons for the stock’s continued climb. On Thursday, the company reported that the Food and Drug Administration (FDA) was moving back its Prescription Drug User Fee Act (PDUFA) action date for lifileucel for patients with advanced melanoma from Nov. 25 to Feb. 24, 2024. While that’s a negative, the positive to be taken from that is the FDA left the door open for working with Iovance for a potentially earlier approval.
And the reason the date was pushed back, according to Iovance, was the FDA’s “insufficient resources” and not anything tied to safety or efficacy concerns regarding lifileucel.
Iovance board member Wayne Rothbaum might have helped goose the stock a bit as well when he bought 5 million shares at an average price of $5.30 through his company, Quogue Capital. The trade was made on Friday and reported the same day.
Now what
If lifileucel is approved, it will be the only therapy of its kind that’s used to treat advanced melanoma, and the first one-dose cell therapy to treat a solid tumor. It could be a potential competitor to Merck (NYSE: MRK) blockbuster Keytruda, which is approved to treat advanced melanoma and other cancers.
Lifileucel is also in late-stage trials to treat non-small cell lung cancer, head and neck squamous cell carcinoma, and cervical cancer. As of the second quarter, the company said it had $317.3 million in cash, enough to fund operations through 2024. The delay in lifileucel’s PDUFA date could mean the company will need to raise additional funds.
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Jim Halley has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Iovance Biotherapeutics and Merck. The Motley Fool has a disclosure policy.
