J.P. Morgan analyst Jessica Fye has maintained their bullish stance on DNLI stock, giving a Buy rating yesterday.
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Jessica Fye’s rating is based on several key considerations regarding Denali Therapeutics. Despite the recent announcement of a three-month extension in the FDA’s review of Denali’s tividenofusp alfa, Fye remains confident in the drug’s eventual approval. The delay was attributed to a response Denali provided to an FDA request for information, which was classified as a major amendment due to a minor discrepancy in the drug’s molecular weight. Importantly, this extension is not related to concerns about the drug’s efficacy, safety, or manufacturing processes.
Moreover, Fye highlights the collaborative and engaged nature of the FDA throughout the review process, noting that clinical site inspections have been completed and CMC inspections are planned. Although Denali’s shares have underperformed year-to-date, partly due to regulatory risk aversion in the biotech sector, Fye believes that the potential value of Denali’s de-risked blood-brain barrier platform is still in its early stages. This potential, combined with the anticipated approval of tividenofusp alfa, underpins her Buy rating for the stock.
In another report released yesterday, Bank of America Securities also maintained a Buy rating on the stock with a $27.00 price target.
Based on the recent corporate insider activity of 33 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of DNLI in relation to earlier this year.