Denali Therapeutics: Strategic Advancements and Promising Pipeline Drive Buy Rating

TD Cowen analyst Brendan Smith has maintained their bullish stance on DNLI stock, giving a Buy rating today.

Brendan Smith’s rating is based on Denali Therapeutics’ strategic advancements in their drug pipeline, particularly the recent submission of a Biologics License Application (BLA) for DNL310 under accelerated approval for treating mucopolysaccharidosis Type II (MPS II). The FDA’s acceptance of this filing could lead to a broad label and a potential launch next year, which is a significant milestone for the company.
Additionally, Denali is making progress with its deeper pipeline, expecting 1-2 new therapeutic candidates each year and anticipating global Phase 2 LUMA data for DNL151 in Parkinson’s Disease by 2026. The ongoing discussions with the FDA regarding an accelerated approval pathway for DNL126 in MPS IIIa, supported by promising proof-of-concept data, further bolster the company’s prospects. These factors collectively contribute to the Buy rating, reflecting confidence in Denali’s potential for growth and innovation in rare disease therapeutics.