What happened
Shares of biopharma company Iovance (IOVA 2.70%) are poised to end Wednesday's trading session almost 11% higher than Tuesday's close, following an encouraging observation from investment analytics outfit Truist. Namely, the odds of an approval of one of its drug prospects seemingly improved after a rival drug developer was granted permission to expand its trials of a similar therapy.
So what
Investors needed a bit of help connecting the dots, but the logic holds up under scrutiny.
On Monday, Instil Bio (TIL 5.83%) announced the Food and Drug Administration had cleared the company's request to widen the scope of its current phase 2 trial of ITIL-168. ITIL-168 is a cellular therapy made using tumor-infiltrating lymphocytes, or TILs, from an individual patient's own tumor tissue. While adding melanoma patients with a relapse after other inhibitors have failed is a far cry from a final approval, it does loosely suggest the FDA sees an upside with the drug and approach.
Image source: Getty Images.
The clearance has implications for Iovance's experimental melanoma drug candidate lifileucel, in that this therapy also uses tumor-infiltrating lymphocytes as part of a patient-specific treatment.
While lifileucel has run into a regulatory headwind -- in the form of the FDA's requests for more information made in October and then again in March -- Truist's analysts believe the FDA's decision regarding ITIL-168 bodes well for Iovance's similar drug. While still risky overall, that risk is now better balanced with the prospective reward by virtue of the stock's 50%-plus pullback from February's high.
Now what
The market's knee-jerk response is understandable, but not necessarily a firm sign that shares are on the mend in a meaningful way.
In the very near term, Iovance stock began Wednesday's session primed for a bounce with or without the Truist-supplied bullishness, having lost 14% of its value from its early September peak. Today's surge still doesn't erase all of that sell-off, and previous, similar rebound efforts made in recent weeks have gotten little traction.
Perhaps the bigger reason a prospective buyer may want to hold off on stepping into a position in Iovance is that Instil Bio's ITIL-168 is still miles away from an approval of its own; a modestly widened phase 2 trial isn't exactly an indication that the drug is a panacea. Also bear in mind that the FDA has tendered questions regarding Iovance's lifileucel in two separate instances now, which may indicate concerns specific to that particular treatment rather than TILs in general.
That's not to say Iovance is unownable. It is to suggest, however, that there's still a large degree of risk packed into owning it.
