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Investing.com - Denali Therapeutics Inc. (NASDAQ:DNLI), a $2.1 billion market cap biotech company, received a boost as the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for DNL310 in Hunter syndrome with priority review. According to InvestingPro data, analysts maintain a Strong Buy consensus on the stock.
The regulatory agency set a Prescription Drug User Fee Act (PDUFA) date of January 5, 2026, for the potential approval decision, according to Stifel, which maintained its Buy rating and $37.00 price target on the stock.
This development follows the FDA’s Breakthrough Therapy Designation (BTD) granted to DNL310 in April, prior to Denali completing its rolling BLA submission in May.
Stifel noted that Denali remains on track for an early-2026 launch of DNL310, which the firm believes has a "best-in-class profile" that could drive meaningful patient switching from existing treatments.
The priority review may also offer positive implications for Denali’s broader blood-brain barrier platform, particularly for its enzyme programs like DNL126 for Sanfilippo syndrome, which uses the same biomarker and has received START designation.
In other recent news, Denali Therapeutics Inc. announced that the U.S. Food and Drug Administration has accepted its Biologics License Application for tividenofusp alfa with Priority Review, aiming for a decision by January 5, 2026. This application seeks accelerated approval for treating Hunter syndrome, a rare genetic disorder. The FDA had previously granted Fast Track and Breakthrough Therapy designations to this therapy. Meanwhile, analysts at Stifel have maintained their Buy rating for Denali Therapeutics, with a price target of $37.00, reflecting confidence in the company’s strategic direction and regulatory processes. In contrast, H.C. Wainwright has adjusted its price target for Denali to $32.00 from $80.00, while still maintaining a Buy rating. This adjustment considers challenges in the rare disease market and shifts in investor sentiment. Denali’s management remains optimistic about its pipeline, including potential advancements in therapies for Pompe disease and Alzheimer’s. The company is also exploring strategic partnerships to leverage its platform and manage cash expenditures effectively.
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