Nuvation Bio Study of Lead Product Candidate Put on Partial Clinical Hold by FDA

By Dean Seal

Nuvation Bio Inc. said Monday that the Food and Drug Administration has put a partial clinical hold on the Phase 1 dose escalation study of its drug candidate NUV-422.

The New York-based biopharmaceutical company said the trial aims to define the maximum tolerated dose for NUV-422 as a treatment for solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer.

The trial started enrolling patients 19 months ago, but following the emergence of a form of eye inflammation in certain patients, Nuvation paused enrollment and reached out to the FDA for guidance, the company said.

While the partial hold is in place, no new patients will be enrolled, though current participants may continue to be treated under the study, Nuvation said.

Share of Nuvation Bio fell 17% in premarket trading to $3.48.

Write to Dean Seal at [e-mail]

(END) Dow Jones Newswires

06-27-22 0800ET