The FDA is floating a new optional, risk-based expedited Investigational New Drug pathway in its FY2027 budget request, intended to speed experimental drugs into early human testing. The proposal would rely on preclinical data that can be confirmed without animal tests. Separately, Takeda ended its partnership with Denali Therapeutics for frontotemporal dementia, returning rights to Denali’s DNL593 drug. Denali said the termination was driven by strategic considerations and not related to efficacy or safety, and it expects to report results from an ongoing early-stage trial later this year. The twin moves underscore how companies are recalibrating early development plans amid changing regulatory expectations and shifting portfolio priorities.