Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, ...

Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for the treatment ...

Denali Therapeutics Inc.'s stock remains stable despite trial setback in ALS. BLA filing for MPS II treatment on track. Click ...

Denali Therapeutics Inc. DNLI announced disappointing top-line results from an analysis of Regimen G of the phase II/III ...

Denali Therapeutics (DNLI) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for ...

The company’s lead program Tividenofusp alfa, an enzyme-replacement therapy for Hunter syndrome, shows promise as a ...

to Buy from Hold with a $37 price target Denali recently aligned with the FDA to file for accelerated approval for their lead candidate DLN310/tividenofusp alfa in MPS IIA/Hunter syndrome with a ...

DNL310, or tividenofusp alfa, is an Enzyme Transport Vehicle (ETV)- enabled iduronate-2-sulfatase (IDS) replacement therapy in development for MPS II (Hunter syndrome). In September, Denali ...

Despite these results, the analyst believes that Denali's core value lies in its Transport Vesicle (TV) platform and the promising prospects of Tividenofusp alfa, which is expected to be submitted for ...

Denali plans to submit a biologics license application for tividenofusp alfa in early 2025. The analyst highlights that Denali is developing a specialized transport vehicle (TV) platform to ...

The company’s lead program Tividenofusp alfa, an enzyme-replacement therapy for Hunter syndrome, shows promise as a best-in-class treatment, the analyst highlights. William Blair has initiated ...