DNLI Begins Rolling BLA Submission for Hunter Syndrome Drug, Stock Up

Shares of Denali Therapeutics (DNLI) gained 11.8% on Wednesday after the company announced that it has initiated a rolling submission of a biologics license application (BLA) for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II). The same has also been received by the Center for Drug Evaluation and Research (CDER) of the FDA.DNLI reported ongoing collaborative and productive engagement with CDER, aligning with the same on the content of the BLA data package, including t ...