Shares of biopharma company Iovance Biotherapeutics (IOVA -8.80%) are down 8.7% as of 12:31 p.m. ET Friday after the company announced it had received feedback from the U.S. Food and Drug Administration (FDA) regarding its new drug application for cancer treatment lifileucel. While the FDA’s request for clarified information regarding the drug’s effectiveness is in no way a rejection of lifileucel, it could potentially prolong the approval process.
But not by much.
The FDA’s feedback is more procedural than not. The regulator is simply looking for more “supplemental assay validation information and comparability data for lifileucel.” In that its Biologics License Application for the therapy is a so-called rolling application that can be updated while it’s being considered for approval, providing the requested information doesn’t force the company to restart the licensing process for lifileucel once the data is collected. The company only has to amend its request. Iovance Biotherapeutics believes this entire addendum can be completed and submitted during the first quarter of the coming year.
If the news seems familiar, it may be because Iovance has reported similar news for lifileucel before. In May of last year, for instance, the FDA provided addressable feedback “regarding its potency assays for lifileucel.” This request pushed the filing date for its Biologics License Application into 2022. For time perspective, the regulator confirmed and affirmed the updated assay data in April of this year, and the company submitted its rolling Biologics License Application — the one the Food and Drug Administration responded to just this week — in August. The seemingly lengthy span between these requests, their responses, and regulatory acknowledgment of these submissions is driving today’s sell-off.
While agonizing for investors, it isn’t unusual for companies to receive multiple requests for additional information during drug trials and after they submit New Drug Applications. Indeed, in some regard they clarify the path forward for biopharma outfits.
That’s arguably the case here. That is, the FDA is telling Iovance what needs to be done in order to give its investigational tumor-infiltrating lymphocyte immunotherapy its best chance of an approval. And, given there are no other drugs specifically designed for melanoma patients who did not respond well to anti-PD-1/L1 or BRAF/MEK inhibitor therapies, those odds are already above average.
This still doesn’t make it an appropriate pick for every portfolio. Even the most promising of biotech and biopharma companies are inherently risky, and should only be owned by investors who can stomach sizable losses should a pivotal drug fail to win the FDA’s approval.
If you were willing to take such a risk on Iovance Biotherapeutics prior to today, though, only lifileucel’s approval timeframe has changed in the meantime. This pullback is a buying opportunity for that particular crowd.