Denali Therapeutics’ FDA Priority Review for New Therapy

Denali Therapeutics ( (DNLI) ) has shared an announcement.

On July 7, 2025, Denali Therapeutics announced that the FDA has accepted and granted Priority Review to their Biologics License Application for tividenofusp alfa, aimed at treating Hunter syndrome, with a decision expected by January 5, 2026. This investigational therapy, leveraging Denali’s TransportVehicle™ platform, represents a potential breakthrough in enzyme replacement therapy by addressing both neurological and physical symptoms of the disease, marking a significant advancement in the field and a pivotal milestone for the company’s pipeline.

The most recent analyst rating on (DNLI) stock is a Buy with a $33.00 price target. To see the full list of analyst forecasts on Denali Therapeutics stock, see the DNLI Stock Forecast page.

Spark’s Take on DNLI Stock

According to Spark, TipRanks’ AI Analyst, DNLI is a Neutral.

Denali Therapeutics faces significant financial hurdles with declining revenues and profitability issues, reflected in poor financial and valuation scores. Technical indicators also suggest a bearish trend. Positive corporate events, such as the BLA submission, offer a potential growth catalyst but are balanced by setbacks like the discontinued ALS trial. The overall outlook remains challenging, with strategic adjustments needed for improvement.

To see Spark’s full report on DNLI stock, click here.

More about Denali Therapeutics

Denali Therapeutics is a biotechnology company focused on developing treatments for neurodegenerative and lysosomal storage diseases by engineering product candidates to cross the blood-brain barrier. The company is based in South San Francisco and employs a strategy of targeting genetically validated pathways and using biomarkers to guide development.

Average Trading Volume: 1,526,507

Technical Sentiment Signal: Sell

Current Market Cap: $2.13B

For a thorough assessment of DNLI stock, go to TipRanks’ Stock Analysis page.