FDA Institutes Partial Hold On Nuvation Bio's Early-Stage Solid Tumor Trial - Read Why

  • The FDA has placed a partial clinical hold on Nuvation Bio Inc's NUVB Phase 1 dose-escalation study of NUV-422 in solid tumors.
  • The company's Phase 1 trial began enrolling patients 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 paused the enrollment of new patients to assess these adverse events further. 
  • Also Read: FDA clears Nuvation Bio's IND Application For NUV-868 In Advanced Solid Tumors.
  • 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 1 study.
  • The company says that with $737.7 million in cash, it is well-positioned to continue developing all of its internal product candidates.
  • The company will provide updates on the direction of the NUV-422 program after it has completed its internal risk-benefit analysis, which will factor in feedback from FDA.
  • Price Action: NUVB shares are down 7.04% at $3.88 during the premarket session on the last check Monday.

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