FDA Grants Breakthrough Therapy Designation to Denali’s …
2 days ago · In September 2024, the company announced that it completed a successful meeting with the FDA’s Center for Drug Evaluation and Research (CDER) division outlining a path …
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy …
Denali’s wholly owned program, DNL310 or tividenofusp alfa, is an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase (IDS) replacement therapy in development for MPS II (Hunter …
FDA Grants Breakthrough Therapy Designation to Tividenofusp …
2 days ago · The FDA granted breakthrough therapy designation (BTD) for tividenofusp alfa (DNL310; Denali Therapeutics) for the treatment of patients with Hunter syndrome (MPS II), a …
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy
1 day ago · About Hunter Syndrome (MPS II) Hunter syndrome (MPS II) is a rare genetic disease that affects over 2,000 individuals in commercially accessible geographies, primarily males, …
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy …
2 days ago · Hunter syndrome (MPS II) is a rare genetic disease that affects over 2,000 individuals in commercially accessible geographies, primarily males, and leads to physical, …
Denali's Hunter Syndrome Drug Gets FDA Breakthrough Status ...
2 days ago · For investors, this news reduces regulatory risk and potentially accelerates revenue timeline, which could catalyze multiple expansion. ... About Hunter Syndrome (MPS II) Hunter …
Denali receives FDA breakthrough status for Hunter syndrome drug
2 days ago · Positive topline data for another orphan disease drug, DNL126 for Sanfilippo Syndrome, has been reported. Jefferies maintained a Buy rating on Denali Therapeutics, …
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy …
2 days ago · Denali obtains Breakthrough Therapy Designation for its experimental candidate, tividenofusp alfa (DNL310), for the treatment of pateints with Hunter syndrome.
Denali Therapeutics gets FDA breakthrough therapy designation …
This designation is in addition to Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation, all previously granted by the FDA for tividenofusp alfa in …
Denali’s DNL310 Eyes Accelerated FDA Approval With
Sep 4, 2024 · Denali Therapeutics plans to seek accelerated FDA approval for DNL310 in Hunter syndrome, showing significant biomarker improvements and clinical benefits in ongoing trials.