Replimune Group Facing 'Significant Risk' on RP1's Ongoing Phase 3 Study, Wedbush Says
Replimune Group (REPL) is facing "significant risk" related to the ongoing phase 3 study of RP1 in melanoma after the US Food and Drug Administration rejected the company's biologics license application for the product candidate, Wedbush Securities said in a Monday note.The FDA rejected the application, citing response assessment uncertainty, study population heterogeneity, and failure to isolate RP1's contribution when administered in combination with nivolumab as deficiencies in the phase 2 IGNYTE trial of of RP1, the brokerage noted."We see no path forward for RP1 with IGNYTE," Wedbush said.Wedbush downgraded its rating on Replimune Group to neutral from outperform, with a lower price target of $2 from $19.Shares of Replimune Group were down more than 62% around midday Monday.Price: $1.81, Change: $-2.95, Percent Change: -62.02%