Oricell Therapeutics moved closer to solid-tumor CAR-T commercialization with a $110 million pre-IPO round earmarked for a GPC3-targeted autologous CAR-T in hepatocellular carcinoma. The funding is intended to expand the company’s global footprint and support the path to registrational trials for Ori-C101, after earlier investigator-initiated and Phase 1 activity. In parallel, the FDA rejected Replimune’s oncolytic virus therapy for melanoma again, citing that the company did not resolve the agency’s trial concerns. Replimune’s vuolimogene oderparepvec (RP-1) has now faced another complete response letter cycle tied to advanced melanoma development and the regulator’s expectations for study evidence. Separately, Replimune also received a second complete response letter for RP-1 for melanoma in connection with a PDUFA date, underscoring the stickiness of FDA review standards for the program. Together, the Oricell financing and the Replimune setbacks highlight how quickly the cell-therapy opportunity can advance on funding—while clinical and regulatory evidence requirements still set the pace for timelines.