Denali Therapeutics: Buy Rating Maintained Amid Strategic Developments and FDA Collaboration

Analyst Tazeen Ahmad of Bank of America Securities maintained a Buy rating on Denali Therapeutics, retaining the price target of $27.00.

Tazeen Ahmad has given his Buy rating due to a combination of factors surrounding Denali Therapeutics’ ongoing developments and strategic positioning. The company has announced a three-month extension to the Biologics License Application for tividenofusp alfa, a treatment for Hunter syndrome, which is now set for a decision by April 2026. This extension was due to a request for updated pharmacological data, classified as a Major Amendment, but it does not indicate concerns about the drug’s approvability.
Denali’s management has been proactive in addressing the FDA’s requests and continues to prepare for the product’s launch. Despite the delay, the company’s commercial potential and clinical profile for the drug remain strong, with a projected $712 million in risk-adjusted peak sales and a 75% probability of success. The delay does not impact the 2026 revenue estimates, and the collaborative nature of the FDA review process provides confidence in Denali’s future prospects. Therefore, the Buy rating is maintained with a price objective of $27.

Ahmad covers the Healthcare sector, focusing on stocks such as Ascendis Pharma, Sarepta Therapeutics, and PTC Therapeutics. According to TipRanks, Ahmad has an average return of -1.8% and a 51.74% success rate on recommended stocks.