William Blair analyst Myles Minter has reiterated their bullish stance on DNLI stock, giving a Buy rating yesterday.
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Myles Minter has given his Buy rating due to a combination of factors that highlight Denali Therapeutics’ promising developments. The company has achieved alignment with the FDA on an accelerated approval pathway for its DNL126 program targeting Sanfilippo syndrome, a condition with no current treatments. This alignment is based on the potential use of cerebrospinal fluid heparan sulfate as a surrogate endpoint, which could predict clinical benefits.
Additionally, Denali’s ongoing Phase I/II trial for DNL126 has shown consistent results over 49 weeks, supporting the potential efficacy of the treatment. Furthermore, the acceptance of the biologics license application for tividenofusp alfa under the accelerated approval pathway for Hunter syndrome, with a PDUFA date set for January 5, 2026, adds to the company’s positive regulatory momentum. The absence of an advisory committee meeting for this review is also seen as a favorable sign, reinforcing the Buy rating.
Minter covers the Healthcare sector, focusing on stocks such as Arcturus Therapeutics, Dianthus Therapeutics, and Moderna. According to TipRanks, Minter has an average return of 10.6% and a 47.41% success rate on recommended stocks.