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The FDA has placed a hold on Denali Therapeutics’ plans to launch a phase 1 rare disease trial, citing concerns about immune reactions to the investigational treatment recorded in preclinical mouse studies. The regulator has requested that Denali adjust its trial protocol “to include a lower starting dose, revised inclusion criteria, certain safety monitoring commitments and stopping rules,” the Bay Area biotech said in a Dec. 4 filing with the Securities and Exchange Commission (SEC). The FDA identified the concerns during its 30-day review of Denali's Investigational New Drug (IND) application for an enzyme replacement therapy dubbed DNL952. The agency is not asking the biotech to conduct any additional preclinical research. “We have submitted our response to the FDA and plan to start the phase 1 study in the first half of 2026, pending the agency’s feedback,” a Denali spokesperson told Fierce Biotech. Denali doesn't expect the hold to significantly delay its phase 12025-12-06 • tbsnews.net
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