Denali Therapeutics reports Q3 EPS (74c), consensus (76c)

Denali expects to continue expanding its TV-enabled pipeline across enzyme, antibody, and oligonucleotide franchises, bringing forward one to two new programs annually. The next most advanced programs include: DNL921 for Alzheimer’s disease; DNL111 for Parkinson’s/Gaucher disease; DNL622 for MPS I; and DNL422 for Parkinson’s disease. Denali and Biogen continue co-development of BIIB122. The Phase 2b LUMA study completed enrollment earlier this year with a data readout expected in 2026, while Denali’s Phase 2a BEACON study in LRRK2-associated Parkinson’s disease remains ongoing. In October, Denali submitted an Investigational New Drug application for DNL952 to begin clinical studies in Pompe disease, expanding the reach of the Enzyme TransportVehicle platform into muscle disease. In October, the company submitted a Clinical Trial Application for DNL628 to initiate clinical studies in Alzheimer’s disease, marking a significant milestone in advancing the Oligonucleotide TransportVehicle platform. In September, Denali completed enrollment in the ongoing Phase 1/2 study of DNL126 to support an accelerated approval path in MPS IIIA, also known as Sanfilippo syndrome type A. Previously announced data demonstrated a significant reduction in cerebrospinal fluid heparan sulfate from baseline, including normalization, and a safety profile that supports continued development. A global Phase 3 confirmatory study is being planned. Phase 1/2 data will be presented in a platform presentation at the 2026 WORLDSymposium.