Key Takeaways Denali posted a Q3 loss of $0.74 per share, wider than last year's $0.63 loss. FDA extended tividenofusp alfa's approval decision to April 2026 after a major amendment.DNLI advanced programs for Sanfilippo, Alzheimer, Parkinson and Pompe diseases.Denali Therapeutics (DNLI) reported a third-quarter 2025 loss of 74 cents per share, narrower than the Zacks Consensus Estimate of a loss of 76 cents. The company reported a loss of 63 cents in the year-ago quarter.The loss per share widened year over ...

Tividenofusp alfa BLA review process for accelerated approval for MPS II continues with productive engagement with the FDA; commercial launch preparations on trackDNL126 Phase 1/2 study enrollment completed, supporting an accelerated approval path in MPS IIIATwo new regulatory applications submitted to initiate clinical studies with DNL628 (OTV:MAPT) for Alzheimer’s disease and DNL952 (ETV:GAA) for Pompe diseaseTim Van Hauwermeiren, CEO of argenx, to join Denali's Board of DirectorsCarole Ho, M.D., Chief Me ...