Nuvation Bio down as FDA slaps clinical hold on NUV-422 trial in solid tumors

The US Food and Drug Administration (FDA) has placed a partial clinical hold on US biotech firm Nuvation Bio’s (NYSE: NUVB) Phase I dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer.

Shares of Nuvation were down 7.04% at $3.88 during the pre-market session on Monday following the announcement, and fell a further 3.8% to $3.50 in early trading today.

The company’s Phase I trial began enrolling patients 19 months ago in December 2020 and, in recent months, was exploring higher doses to define a maximum tolerated dose. Following the emergence of uveitis, a form of inflammation in the eye, in certain patients receiving NUV-422, the company proactively paused enrollment of new patients in order to further assess these adverse events with investigators and uveitis experts, and also reached out to the FDA for guidance around an appropriate path forward. While the partial hold is in place, no new patients will be enrolled in the NUV-422 program, although current study participants may continue to be treated in the Phase I study.