We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Denali Therapeutics Unveils Portfolio Goals for 2026, Stock Up
Read MoreHide Full Article
Key Takeaways
DNLI outlined a 2026 roadmap as it prepares for potential FDA approval and launch of tividenofusp alfa.
FDA extended the BLA review for tividenofusp alfa to April 5, 2026, after updated clinical pharmacology data
Several programs target 2026 readouts, including DNL126 data and BIIB122 LUMA results.
Denali Therapeutics Inc. (DNLI - Free Report) recently outlined its roadmap for 2026 across its portfolio of investigational therapies for neurodegenerative diseases, lysosomal storage disorders and other serious diseases.
Denali Therapeutics is preparing for the anticipated FDA approval and commercial launch of tividenofusp alfa, its investigational therapy for Hunter syndrome. The company expects 2026 to mark the first commercial validation of its platform.
Shares of Denali Therapeutics gained 7.43% yesterday and were up 2.5% in after-market trading.
More on DNLI’s Hunter Syndrome Drug
Denali Therapeutics is developing DNL310 or tividenofuspalfa, an Enzyme Transport Vehicle (ETV)-enabled iduronate-2-sulfatase (IDS) replacement therapy, for the treatment of MPS II (Hunter syndrome). It is designed to cross the blood-brain barrier (BBB) and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain.
Denali Therapeutics submitted a biologics license application (BLA) for tividenofuspalfa under the FDA’s accelerated approval pathway based on data from the phase I/II study in participants with Hunter syndrome.
However, in October 2025, the FDA extended its review timeline of the BLA seeking accelerated approval of tividenofusp alfa. The target date has been extended to April 5, 2026, from Jan. 5, 2026. The extension follows the company’s submission of updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process and is not related to efficacy, safety or biomarkers.
The regulatory body had previously granted Breakthrough Therapy, Fast Track, Orphan Drug and Rare Pediatric Disease designations to this therapy.
A potential approval will be a significant boost to the company’s growth prospects as there are very few effective therapeutic options available for patients with diseases such as Hunter syndrome.
A phase II/III COMPASS study is ongoing. Data from this study is expected to generate confirmatory evidence and support global regulatory submissions.
DNLI’s Other Key Milestones Targeted for 2026
Denali Therapeutics is evaluating DNL126 for the treatment of Sanfilippo syndrome type A (MPS IIIA). In September, the company completed enrollment in the ongoing phase I/II study of DNL126. This study is designed to support an accelerated approval path in Sanfilippo syndrome type A.
Initial data from DNL126 for Sanfilippo syndrome Type A are scheduled to be presented at the 2026 WORLDSymposium in February. A global phase III confirmatory study is being planned.
Denali Therapeutics is also developing other candidates in partnership with Takeda (TAK - Free Report) and Biogen (BIIB - Free Report) .
Denali Therapeutics and partner Takeda have collaborated to develop DNL593, an investigational therapeutic designed to deliver progranulin across the blood-brain barrier for the treatment of granulin (GRN) mutation-associated frontotemporal dementia (FTD-GRN).
A phase I/II study on TAK-594/DNL593 is ongoing and initial FTD-GRN patient data are expected in 2026.
DNLI is evaluating DNL628 (OTV:MAPT) for Alzheimer’s disease. Its clinical trial application for DNL628 for the phase Ib study of DNL628 has been approved and study start-up activities are underway. The approval marks a significant milestone in advancing the oligonucleotide Transport Vehicle (OTV) platform.
Meanwhile, Denali Therapeutics and Biogen continue co-development of BIIB122. Biogen is leading the global phase IIb LUMA study, evaluating BIIB122's impact on disease progression in early-stage Parkinson’s disease (PD). The LUMA study is fully enrolled and a readout is expected in 2026.
Denali Therapeutics is conducting the phase IIa BEACON study, specifically enrolling participants with LRRK2-associated PD to assess how LRRK2 inhibition may impact this disease.
Denali Therapeutics recently announced that the FDA has lifted the clinical hold on the investigational new drug application for DNL952 for Pompe disease. The company plans to begin a phase I study. The therapy is engineered to enhance enzyme delivery into muscle tissues and the brain.
Denali Therapeutics also stands to receive royalty payments for SAR443122/DNL758, which is licensed to Sanofi (SNY - Free Report) and is in development for ulcerative colitis.
Results from the Sanofi-partnered RIPK1 inhibitor eclitasertib (SAR443122/DNL758) in ulcerative colitis are expected in the first half of 2026.
DNLI’s Strong Cash Position
As of Sept. 30, 2025, the company held approximately $872.9 million in cash and marketable securities. In December, it raised an additional $200 million through equity financing and secured a royalty funding agreement with Royalty Pharma worth up to $275 million based on future potential sales of tividenofusp alfa.
These moves provide the capital required to support regulatory activities, fund new clinical trials and prepare for commercialization activities for tividenofusp alfa.
Road Ahead for DNLI
2026 positions Denali Therapeutics at an inflection point. A potential FDA approval of tividenofusp alfa would transform the company into a commercial-stage biotech. Positive data readouts from ongoing studies will also provide impetus to the stock.
Shares of DNLI have lost 19% in the past year against the industry’s 17.2% growth.
Image Source: Zacks Investment Research
However, any additional regulatory setback will be detrimental to DNLI’s growth prospects.
Image: Bigstock
Denali Therapeutics Unveils Portfolio Goals for 2026, Stock Up
Key Takeaways
Denali Therapeutics Inc. (DNLI - Free Report) recently outlined its roadmap for 2026 across its portfolio of investigational therapies for neurodegenerative diseases, lysosomal storage disorders and other serious diseases.
Denali Therapeutics is preparing for the anticipated FDA approval and commercial launch of tividenofusp alfa, its investigational therapy for Hunter syndrome. The company expects 2026 to mark the first commercial validation of its platform.
Shares of Denali Therapeutics gained 7.43% yesterday and were up 2.5% in after-market trading.
More on DNLI’s Hunter Syndrome Drug
Denali Therapeutics is developing DNL310 or tividenofuspalfa, an Enzyme Transport Vehicle (ETV)-enabled iduronate-2-sulfatase (IDS) replacement therapy, for the treatment of MPS II (Hunter syndrome). It is designed to cross the blood-brain barrier (BBB) and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain.
Denali Therapeutics submitted a biologics license application (BLA) for tividenofuspalfa under the FDA’s accelerated approval pathway based on data from the phase I/II study in participants with Hunter syndrome.
However, in October 2025, the FDA extended its review timeline of the BLA seeking accelerated approval of tividenofusp alfa. The target date has been extended to April 5, 2026, from Jan. 5, 2026. The extension follows the company’s submission of updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process and is not related to efficacy, safety or biomarkers.
The regulatory body had previously granted Breakthrough Therapy, Fast Track, Orphan Drug and Rare Pediatric Disease designations to this therapy.
A potential approval will be a significant boost to the company’s growth prospects as there are very few effective therapeutic options available for patients with diseases such as Hunter syndrome.
A phase II/III COMPASS study is ongoing. Data from this study is expected to generate confirmatory evidence and support global regulatory submissions.
DNLI’s Other Key Milestones Targeted for 2026
Denali Therapeutics is evaluating DNL126 for the treatment of Sanfilippo syndrome type A (MPS IIIA). In September, the company completed enrollment in the ongoing phase I/II study of DNL126. This study is designed to support an accelerated approval path in Sanfilippo syndrome type A.
Initial data from DNL126 for Sanfilippo syndrome Type A are scheduled to be presented at the 2026 WORLDSymposium in February. A global phase III confirmatory study is being planned.
Denali Therapeutics is also developing other candidates in partnership with Takeda (TAK - Free Report) and Biogen (BIIB - Free Report) .
Denali Therapeutics and partner Takeda have collaborated to develop DNL593, an investigational therapeutic designed to deliver progranulin across the blood-brain barrier for the treatment of granulin (GRN) mutation-associated frontotemporal dementia (FTD-GRN).
A phase I/II study on TAK-594/DNL593 is ongoing and initial FTD-GRN patient data are expected in 2026.
DNLI is evaluating DNL628 (OTV:MAPT) for Alzheimer’s disease. Its clinical trial application for DNL628 for the phase Ib study of DNL628 has been approved and study start-up activities are underway. The approval marks a significant milestone in advancing the oligonucleotide Transport Vehicle (OTV) platform.
Meanwhile, Denali Therapeutics and Biogen continue co-development of BIIB122. Biogen is leading the global phase IIb LUMA study, evaluating BIIB122's impact on disease progression in early-stage Parkinson’s disease (PD). The LUMA study is fully enrolled and a readout is expected in 2026.
Denali Therapeutics is conducting the phase IIa BEACON study, specifically enrolling participants with LRRK2-associated PD to assess how LRRK2 inhibition may impact this disease.
Denali Therapeutics recently announced that the FDA has lifted the clinical hold on the investigational new drug application for DNL952 for Pompe disease. The company plans to begin a phase I study. The therapy is engineered to enhance enzyme delivery into muscle tissues and the brain.
Denali Therapeutics also stands to receive royalty payments for SAR443122/DNL758, which is licensed to Sanofi (SNY - Free Report) and is in development for ulcerative colitis.
Results from the Sanofi-partnered RIPK1 inhibitor eclitasertib (SAR443122/DNL758) in ulcerative colitis are expected in the first half of 2026.
DNLI’s Strong Cash Position
As of Sept. 30, 2025, the company held approximately $872.9 million in cash and marketable securities. In December, it raised an additional $200 million through equity financing and secured a royalty funding agreement with Royalty Pharma worth up to $275 million based on future potential sales of tividenofusp alfa.
These moves provide the capital required to support regulatory activities, fund new clinical trials and prepare for commercialization activities for tividenofusp alfa.
Road Ahead for DNLI
2026 positions Denali Therapeutics at an inflection point. A potential FDA approval of tividenofusp alfa would transform the company into a commercial-stage biotech. Positive data readouts from ongoing studies will also provide impetus to the stock.
Shares of DNLI have lost 19% in the past year against the industry’s 17.2% growth.
Image Source: Zacks Investment Research
However, any additional regulatory setback will be detrimental to DNLI’s growth prospects.
DNLI’s Zacks Rank
Denali Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.