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Investing.com - H.C. Wainwright has reiterated its Buy rating and $32.00 price target on Denali Therapeutics Inc. (NASDAQ:DNLI) despite a three-month PDUFA extension for the company’s tividenofusp alfa drug. The stock, currently trading at $15.21, shows potential upside according to InvestingPro analysis, with analyst targets ranging from $24 to $40 and a strong balance sheet featuring more cash than debt.
The FDA extension was reportedly triggered by a clerical discrepancy in a public database value affecting theoretical molecular weight used in pharmacology modeling, according to H.C. Wainwright analyst Andrew Fein. Although the variance was only around 5% and described as clinically immaterial, the FDA classified the correction as a Major Amendment. This development comes as six analysts have revised their earnings expectations upward for the upcoming period, according to InvestingPro data.
The issue appears unrelated to efficacy, safety, or biomarkers, with H.C. Wainwright describing it as a narrow, well-defined problem that ideally could have been resolved through a phone call rather than a formal extension.
Denali’s management has indicated that commercial readiness remains on track despite the delay, which may provide additional time for payer, KOL, and community engagement activities.
The extension reflects broader challenges at the FDA, which is experiencing strain from leadership turnover, staff reductions, and resource constraints, resulting in procedural approaches to issues that might previously have been resolved informally.
In other recent news, Denali Therapeutics Inc. has announced a delay in the FDA review of its Hunter syndrome treatment, tividenofusp alfa. The U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) date by three months, moving it from January 5, 2026, to April 5, 2026. This extension follows the company’s submission of updated clinical pharmacology information, which the FDA classified as a Major Amendment to the Biologics License Application (BLA). Despite this delay, Stifel has maintained its Buy rating on Denali Therapeutics with a price target of $37.00. Cantor Fitzgerald also reiterated its Overweight rating, expressing optimism about Denali’s future potential. Additionally, BTIG has reaffirmed a Buy rating with a $32.00 price target, noting the advantages of Denali’s blood-brain barrier shuttle technology. This technology allows for higher dosing with acceptable safety profiles compared to other treatments. These developments reflect ongoing confidence in Denali’s innovative approaches despite regulatory delays.
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