Clinical Trial Failure Risk: The success of Nuvalent's drug candidates depends heavily on the outcomes of their ongoing and future clinical trials, and any failure to demonstrate efficacy or safety could halt development and significantly devalue the company.

Regulatory Approval Uncertainty Risk: Even with positive clinical trial results, Nuvalent's drug candidates must receive regulatory approvals from agencies like the FDA, a process that is lengthy, expensive, and uncertain, potentially delaying or preventing market access.

Funding and Capital Requirements Risk: Developing new therapies is capital-intensive, and Nuvalent may require significant additional funding to complete clinical trials, secure approvals, and commercialize products, which may not be available on favorable terms or at all.