DNLI's BLA for Hunter Syndrome Drug Gets FDA's Priority Review

Key Takeaways FDA accepted DNLI's BLA for tividenofusp alfa in Hunter syndrome, with Priority Review granted. Tividenofusp alfa uses DNLI's TV platform to address both cognitive and physical symptoms of MPS II. A potential approval would be DNLI's first, significantly advancing its move to a commercial biotech.Denali Therapeutics, Inc. (DNLI) announced that the FDA has accepted for review its biologics license application (BLA) for lead-pipeline candidate tividenofusp alfa.The BLA is seeking accelerated a ...