Denali Therapeutics: Vast Pipeline, First Approval Up Ahead

2025-03-20 14:16:45 ET

Summary

• Denali Therapeutics' stock has significantly dropped from $100 to $15 since 2021, but the company is now heavily derisked with promising product candidates nearing key milestones.
• Lead asset DNL310 shows strong biomarker data for Hunter syndrome, with plans for a BLA submission and accelerated approval by Q2 2025.
• The Biogen partnership for Parkinson’s Disease asset DNL151 includes substantial milestone payments and profit-sharing, highlighting its potential impact.
• Despite past failures, Denali's extensive pipeline and solid financial runway make it a compelling buy at current low stock prices.

I covered Denali Therapeutics ( DNLI ) in 2021, when it was an early stage Parkinson’s Disease company with a $10bn valuation. At that time, I said I thought that valuation was unjustified. The stock at that time was trading near $100; today, it trades at $15 and the market cap is $2.2bn. What's more, the stock is heavily derisked from what it was in 2021, with one product candidate nearing a BLA submission and another - the Parkinson’s Disease asset that induced Biogen’s involvement and attracted such a valuation - is approaching proof of concept stages....

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