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Investing.com - Stifel maintained its Buy rating and $37.00 price target on Denali Therapeutics Inc. (NASDAQ:DNLI) following discussions with the company’s CEO at a recent healthcare conference. This target represents a potential 110% upside from the current price of $17.58, aligning with the broader analyst community’s bullish stance, as revealed by InvestingPro data showing analyst targets ranging from $24 to $40.
The research firm noted that the FDA’s PDUFA extension for Denali’s DNL310 drug was due to a clerical error in a molecular weight calculation rather than concerns about efficacy or safety. The company reported ongoing productive engagement with regulators and is currently in labeling discussions, suggesting approval might occur before the new PDUFA date.
Denali also received regulatory alignment to file for accelerated approval of DNL126 in Sanfilippo syndrome based on cerebrospinal fluid heparan-sulfate data. Results from a 49-week study are expected at the WORLD conference in February.
The company’s pipeline includes DNL628, an anti-tau oligonucleotide for Alzheimer’s disease, which management believes shows promising potential based on preclinical data showing broad biodistribution and strong MAPT knockdown.
Stifel’s $37.00 price target reflects confidence in Denali’s development programs and regulatory progress across multiple therapeutic candidates.
In other recent news, Denali Therapeutics announced changes in its leadership team, with Tim Van Hauwermeiren joining the Board of Directors and Carole Ho departing to join Eli Lilly and Company. Additionally, Peter Chin has been appointed as Acting Chief Medical Officer. The U.S. Food and Drug Administration (FDA) has extended the review timeline for Denali’s Hunter syndrome treatment, tividenofusp alfa, by three months. This delay was due to a clerical discrepancy, classified as a Major Amendment, in the clinical pharmacology information submitted by the company.
H.C. Wainwright has maintained its Buy rating on Denali Therapeutics, setting a price target of $32.00, despite the FDA extension. Stifel also reiterated its Buy rating, with a price target of $37.00, following the regulatory review delay. Cantor Fitzgerald continues to hold an Overweight rating on the company, expressing optimism about Denali’s potential growth. These developments reflect the ongoing interest and positive outlook from analysts regarding Denali Therapeutics.
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