Iovance Biotherapeutics (NASDAQ:IOVA) added ~8% in the morning hours Friday as Piper Sandler upgraded the clinical-stage biotech to Overweight from Neutral, citing potential FDA approval for its lead asset lifileucel in melanoma later this year.
The analyst Joseph Catanzaro expects Iovance (IOVA) to submit the marketing application for lifileucel within this quarter “without any further delays,” even as discussions over its potency have dragged on for nearly 2.5 years amid lack of clarity.
In November, the company announced its decision to delay the rolling submission of the lifileucel biologics license application after the FDA requested additional information.
“….the level of visibility into this issue has been and will continue to be limited,” the analyst added while raising the IOVA price target to $14 from $11 per share.
The treatment “has a good likelihood of approval later this year and that the initial launch could surprise to the upside,” Catanzaro wrote. The analyst expects the company to realize its lifileucel opportunity over the next 12 – 18 months as a second-line option for melanoma in a post-PD-1 setting.
Following a company conference call, Seeking Alpha contributor BioSci Capital Partners wrote early this month that Iovance (IOVA) “management seemed quite confident in their ability to complete the rolling of BLA for lifileucel by this quarter.”