After FDA Hold, Nuvation Bio Stops NUV-422 Cancer Development Program

Nuvation Bio Inc NUVB will discontinue the clinical development of NUV-422 after an internal risk-benefit analysis factoring in feedback from the FDA in a partial clinical hold letter for monotherapy Phase 1/2 study and clinical hold letters for its combination Phase 1b/2 studies.
The FDA verbally placed a partial clinical hold on the Phase 1 dose escalation portion of the company's NUV-422-02 study in June.
At that time, the company had proactively paused enrollment of new patients following the emergence of a safety signal, uveitis, a form of eye inflammation.
Furthermore, the FDA requested a mitigation plan to address the adverse event of uveitis. The etiology of uveitis associated with NUV-422 is not understood, and its development appears unpredictable.
The company believes crafting an effective mitigation plan would be challenging without significant further research.
Nuvation Bio will intensify its focus on the clinical development of NUV-868 and identify a lead clinical candidate from its novel small molecule Drug-Drug Conjugate platform.
A reduction in workforce of 35% and other cost savings associated with the NUV-422 program discontinuation will enable Nuvation Bio to extend its cash runway through 2028.
The company expects to report a balance of approximately $703.8 million in cash, cash equivalents, and marketable securities as of June 30.
Price Action: NUVB shares are down 5.07% at $2.62 during the premarket session on the last check Monday.