Denali noted no FDA panel meeting in call with William Blair

William Blair keeps an Outperform rating on Denali Therapeutics (DNLI) after the company announced that a biologics license application for tividenofusp alfa was accepted by the FDA for the treatment of Hunter syndrome under the accelerated approval pathway. Management in a follow-up call noted no mention of an FDA advisory committee meeting as part of the review process at this time, which is a positive, the analyst tells investors in a research note. Blair believes the data support a “potential best-in-class treatment option.” It expects global peak sales of tividenofusp of $784M and views Denali as an “undervalued late-stage biotech name.”