William Blair has initiated coverage on Denali Therapeutics Inc (NASDAQ:DNLI), a company focused on developing drugs for neurodegenerative diseases.
The analyst highlights that Denali is developing a specialized transport vehicle (TV) platform to enhance the delivery of treatments across the blood-brain barrier.
It stands out from competitors with its promising potential for top-tier performance and scalability across different therapies and conditions.
The company’s lead program Tividenofusp alfa, an enzyme-replacement therapy for Hunter syndrome, shows promise as a best-in-class treatment, the analyst highlights.
William Blair has initiated with an Outperform rating and a fair value of $35 per share.
The company has reached an agreement with the FDA on the requirements for accelerated approval and plans to submit a biologics license application in early 2025.
Insights gained from tividenofusp alfa may also simplify the development and approval process for future treatments targeting other lysosomal storage diseases, such as DNL126 for Sanfilippo syndrome type A.
Most recently, Denali Therapeutics initiated dosing in a global BEACON Phase 2a trial of BIIB122 (DNL151) for LRRK2-associated Parkinson’s disease.
Denali’s market cap stands at $2.93 billion, with an enterprise value of $2.26 billion.
Compared to its peers in neuroscience, rare diseases, and platform biotech, its valuation is lower than some but higher than others, reflecting the strength of its pipeline and technology.
William Blair notes the potential for significant growth as Denali advances its assets, including tividenofusp, which might receive accelerated approval and priority review by late 2025.
If additional clinical data reduces risks associated with its TV-enabled approach, Denali could achieve valuations similar to companies like Avidity Biosciences Inc. (NASDAQ:RNA), Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), Biogen Inc. (NASDAQ:BIIB), Alnylam Pharmaceuticals, Inc.(NASDAQ:ALNY), and Ionis Pharmaceuticals, Inc. (NASDAQ:IONS).
Price Action: DNLI stock is up 3.17% at $21.50 at the last check on Friday.
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