Denali Therapeutics Inc. (DNLI) announced that its meeting with the Center for Drug Evaluation and Research ("CDER") division of the FDA for the advancement of pipeline candidate tividenofusp alfa (DNL310) was successful. Tividenofusp alfa (DNL310) is being evaluated for the treatment of MPS II (Hunter syndrome). The meeting with CDER outlined a path for Denali to file a biologics license application (BLA) seeking accelerated approval of tividenofusp alfa (DNL310) for the treatment of MPS II and its subsequ ...