Progressive shares fall as Q3 earnings, revenue miss expectations
Investing.com - Stifel maintained its Buy rating and $37.00 price target on Denali Therapeutics Inc. (NASDAQ:DNLI), currently trading at $14.98, following news of a regulatory review extension for its Hunter syndrome treatment. According to InvestingPro data, analysts remain bullish with a consensus target range of $24-40.
The U.S. Food and Drug Administration (FDA) has delayed the Prescription Drug User Fee Act (PDUFA) date for Denali’s DNL310 therapy by three months to April 5, 2026, from the previously scheduled January 5 date.
The delay occurred after the FDA classified Denali’s submission of updated clinical pharmacology information as a major amendment, automatically extending the review timeline. According to Denali, the information request was part of the standard review process and not related to efficacy, safety, or biomarkers.
The company reported that no additional data was requested in the major amendment letter, and Denali does not believe the updated information affects the clinical pharmacology or benefit/risk conclusions of the Biologics License Application (BLA).
DNL310 has previously received Breakthrough Therapy Designation and priority review from the FDA, which Stifel notes should support accelerated approval and subsequent launch in the first half of 2026. Investors tracking this development should note Denali’s next earnings report is scheduled for October 30. Get deeper insights and additional ProTips with InvestingPro.
In other recent news, Denali Therapeutics Inc. announced that the U.S. Food and Drug Administration has extended its review timeline for tividenofusp alfa, a treatment for Hunter syndrome. The FDA moved the target action date from January 5, 2026, to April 5, 2026, due to Denali’s submission of updated clinical pharmacology information, which was classified as a Major Amendment to the Biologics License Application. Cantor Fitzgerald has reiterated its Overweight rating on Denali Therapeutics, maintaining a positive outlook and suggesting that Denali could become as influential as Genzyme, a company known for its enzyme replacement therapies. Furthermore, BTIG has maintained its Buy rating and set a $32.00 price target for Denali Therapeutics, highlighting the company’s advancements in blood-brain barrier shuttle technology. BTIG noted that Denali’s DNL310 can be dosed up to 30mg/kg with acceptable safety profiles, a significant improvement over JCR’s approved version of iduronate 2-sulfatase without causing unacceptable anemia. These recent developments continue to capture the attention of analysts and investors alike.
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