Denali Therapeutics Inc. (DNLI)

Over the past six months, Denali Therapeutics' stock price has fluctuated due to clinical development updates and regulatory reviews. The stock has risen 4.79% over the last six months, but decreased 39.34% over the last year. In October 2025, the FDA extended its review timeline for tividenofusp alfa, moving the PDUFA target date to April 5, 2026, following the submission of updated clinical pharmacology information. Denali's stock advanced 16.2% following its most recent earnings report in October 2025. In September 2025, an update was submitted for the Phase 1/2 clinical study of DNL593 for Frontotemporal Dementia (FTD-GRN). In August 2025, Denali reported its Q2 2025 earnings, posting an EPS of -$0.72, exceeding analysts' expectations. In July 2025, the FDA accepted and granted Priority Review for tividenofusp alfa, setting an initial PDUFA target action date of January 5, 2026. In April 2025, the stock reached its all-time low of $10.57.

Information specifically detailing demand seasonality for Denali Therapeutics' products and services is not readily available, as the company is primarily a clinical-stage biopharmaceutical company. Its revenue largely comes from strategic collaborations, milestone payments, and licensing agreements, rather than direct product sales to consumers. The company's stock performance can exhibit seasonality, with historical data suggesting a short bias for October and a statistically strong window culminating around November 15th. General market trends and news related to clinical trial results or regulatory approvals in the biotechnology sector are more likely to influence the company's financial performance and stock price than seasonal consumer demand.

Denali Therapeutics Inc. is a biopharmaceutical company focused on discovering and developing therapies for neurodegenerative diseases, including Alzheimer's, Parkinson's, ALS, and lysosomal storage diseases. The company engineers therapies to cross the blood-brain barrier using its Transport Vehicle (TV) technology to deliver large therapeutic molecules to the brain. Key products and pipeline candidates include Tividenofusp alfa (DNL310) for Hunter syndrome, BIIB122/DNL151 for Parkinson's disease, DNL343 for ALS, Eclitasertib (SAR443122/DNL758) for inflammatory diseases, TAK-594/DNL593 for frontotemporal dementia, DNL126 for MPS IIIA, DNL952 for Pompe disease, DNL111 for Parkinson's and Gaucher diseases, DNL622 for Hurler syndrome, DNL628 for Alzheimer's disease, DNL422 for Parkinson's disease, and DNL921 for Alzheimer's disease. Denali partners with major pharmaceutical companies like Biogen, Sanofi, Takeda, Genentech, and AbbVie.

Denali Therapeutics Inc. is headquartered in South San Francisco, California, and has research sites in Cambridge, Massachusetts. The company supports global clinical trials and its stock is traded on NASDAQ in the US, several German exchanges, the Berne Stock Exchange in Switzerland, and the Sao Paulo Stock Exchange in Brazil.

Denali Therapeutics is recognized as a biopharmaceutical company focused on developing therapies for neurodegenerative and lysosomal storage diseases, leveraging its proprietary blood-brain barrier technology. The company's mission is to defeat neurodegenerative diseases through rigorous scientific approaches and a commitment to patients, valuing innovation, collaboration, and a patient-centric approach. The company's reputation has been influenced by clinical trial progress and regulatory interactions. The FDA's acceptance and priority review of the BLA for tividenofusp alfa was a positive development, while the subsequent extension of the review timeline introduced some regulatory uncertainty. Analyst firms generally remain optimistic, issuing "Buy" ratings with price targets significantly above the current stock price. The company's strong balance sheet and strategic partnerships also contribute positively to its perception.

Denali Therapeutics Inc. has significant institutional ownership, with 518 institutional owners and shareholders holding 157,383,886 shares, representing approximately 92.92% of the stock. Major institutional owners include BlackRock, Inc., Baillie Gifford & Co., Vanguard Group Inc., Fmr Llc, Price T Rowe Associates Inc /Md/, UBS Asset Management Americas Inc., Wellington Management Group Llp, Temasek Holdings (Private) Ltd., Capital Research Global Investors, State Street Corp., and Biogen Inc. In the past three months, insiders have sold $91,569.00 of stock and bought $0.00, holding 12.50% of the stock.