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Denali Therapeutics ( (DNLI) ) has shared an update.
On October 13, 2025, Denali Therapeutics announced that the FDA has extended the review timeline for its Biologics License Application for tividenofusp alfa, a treatment for Hunter syndrome. The extension, from January 5, 2026, to April 5, 2026, is due to the submission of updated clinical pharmacology information, classified as a Major Amendment, and is not related to the drug’s efficacy or safety. Denali remains committed to preparing for the potential approval and commercial launch of tividenofusp alfa, which aims to address both central nervous system and peripheral symptoms of Hunter syndrome.
The most recent analyst rating on (DNLI) stock is a Buy with a $37.00 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. The company specializes in engineering product candidates to cross the blood-brain barrier, aiming to address unmet medical needs in these areas.
Average Trading Volume: 1,930,187
Technical Sentiment Signal: Sell
Current Market Cap: $2.25B
See more data about DNLI stock on TipRanks’ Stock Analysis page.