On a brutal day for biotech stocks, Iovance Biotherapeutics (IOVA 1.15%) is defying the broader trend across the space. Specifically, the adoptive cell therapy company's shares were up by 7.75% on heavy volume as of 11:49 a.m. ET Wednesday.
Meanwhile, the iShares Biotechnology ETF was down by 1.6%, and the SPDR S&P Biotech ETF was in the red by 2.63% at the same point in today's trading session. These two ETFs are widely considered bellwethers for the biopharmaceutical industry.
What's sparking Iovance's contrarian move?
Tuesday, Iovance announced its 2023 third-quarter earnings. While its financial results are largely immaterial at this point in its lifecycle, the company did note that it is making progress toward the possible commercial debut of lifileucel, a polyclonal tumor-infiltrating lymphocyte (TIL) therapy indicated for patients with advanced melanoma.
The therapy is presently under regulatory review by the Food and Drug Administration (FDA), and the agency is expected to make a decision on lifileucel's Biologics License Application by Feb. 24, 2024.
NASDAQ: IOVA
Key Data Points
What's the big deal? If approved in the U.S. and other key territories, Iovance's TIL therapy could possibly generate peak sales in the range of $700 million to perhaps $1 billion as a treatment for advanced melanoma. That's an enormous commercial opportunity for a biotech company with a market cap hovering around $1 billion at the time of this writing.
Is this biotech still a buy?
It depends on your comfort with risk. FDA regulatory reviews are hard to predict, and commercial launches of cell therapies are even more so. That being said, Iovance does sport an intriguing value proposition, given lifileucel's potential to address a clear-cut medical need. Nonetheless, this stock is arguably still best suited for the risk-tolerant crowd.
