Denali Therapeutics Faces Critical Investor Update Amid Regulatory Setback

Investors in Denali Therapeutics are bracing for a pivotal market update as the biotechnology firm prepares to release its third-quarter 2025 financial results. The upcoming conference call represents a significant moment for the company, which continues to navigate challenges following recent regulatory developments.

Market analysts project Denali will report a loss of $0.76 per share with revenue approximating $1 million. These figures come against the backdrop of a substantial regulatory delay that has impacted the company’s timeline. The U.S. Food and Drug Administration has rescheduled its decision on tividenofusp alfa, Denali’s potential treatment for Hunter syndrome, pushing the review period from January to April 2026. While the deferral resulted from procedural requirements Read more...