Iovance PDUFA not impacted, upside still ahead despite clinical hold, says Baird

Baird notes that Iovance Biotherapeutics announced that the FDA has placed on clinical hold the IOV-LUN-202 study, the company’s Phase 2 trial of LN-145 tumor infiltrating lymphocyte therapy in patients with metastatic non-small-cell lung cancer after a report of a Grade 5 serious adverse event, namely a patient death. While the firm sees this as “disappointing news,” it points out that the partial hold is only for NSCLC and does not impact any other clinical trial or the nearing melanoma PDUFA. As the scope of the partial hold seems narrowed to NSCLC, Baird thinks there is still upside on melanoma approval and removal of clinical hold. The firm has an Outperform rating on the shares with a $20 price target.