Street View: Denali's first FDA nod signals regulatory flexibility for rare disease approvals

The U.S. Food and Drug Administration on Wednesday approved Denali Therapeutics' DNLI.O therapy to treat children with a rare genetic disorder, marking the first regulatory green light for the drugmaker in the country.

APPROVAL EASES INVESTOR CONCERNS

William Blair ("outperform") says approval does suggest regulatory flexibility for rare disease, which could be a sector tailwind given FDA volatility and investor skepticism

TD Cowen ("buy") says the approval should come as welcome news following a three-month delay and uncertainty at the FDA; "likely a welcome relief for investors"

Jefferies ("buy," PT: $40) says approval was generally expected despite the rejection for Regenxbio's gene therapy, RGX-121, for Hunter syndrome, says the decision is "still de-risking" for DNLI

BTIG ("buy," PT: $38) says the approval gives DNLI a clear path to get complex drugs approved, which it can now leverage to fast-track the rest of its pipeline

Evercore ISI ("outperform," PT: $31) says approval for co's treatment, Avlayah, was "widely-expected", says label supports a broader pediatric Hunter syndrome opportunity