FDA Grants Breakthrough Therapy Designation to Denali’s Tividenofusp …
Jan 9, 2025 · Tividenofusp alfa received FDA breakthrough therapy designation for Hunter syndrome, with a biologics license application planned for early 2025. The therapy optimizes enzyme delivery to the brain and body, normalizing key …
FDA Grants Breakthrough Therapy Designation to Tividenofusp Alfa …
Jan 9, 2025 · Tividenofusp alfa received FDA breakthrough therapy designation for Hunter syndrome, enabling expedited review due to promising preliminary clinical evidence. Phase 1/2 study results showed normalization of cerebrospinal fluid heparan sulfate and improved lysosomal function biomarkers.
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy
Jan 8, 2025 · Denali expects to submit a Biologics License Application (BLA) for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway.
Denali Therapeutics Announces New Data and Expansion of Its …
Feb 7, 2024 · New data show additional improvement and stabilization in clinical outcomes in MPS II with 104 weeks of tividenofusp alfa (DNL310) treatment in the open-label, single-arm Phase 1/2 study ...
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy …
Jan 8, 2025 · Denali expects to submit a Biologics License Application (BLA) for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway.
Denali Therapeutics Announces New Data and Expansion of Its
Feb 7, 2024 · New data show additional improvement and stabilization in clinical outcomes in MPS II with 104 weeks of tividenofusp alfa (DNL310) treatment in the open-label, single-arm Phase 1/2 study ...
Denali Therapeutics Announces Successful Meeting with the FDA …
Sep 3, 2024 · Based on discussions with CDER, Denali will include preclinical and clinical data on biomarkers (CSF HS and neurofilament light (NfL)) and safety in the BLA for tividenofusp alfa as a treatment...
Denali’s DNL310 Eyes Accelerated FDA Approval With
Sep 4, 2024 · DNL310, also known as tividenofusp alfa, has been supported by data from an ongoing, open-label, single-arm phase 1/2 study. It is also being studied in phase 2/3 COMPASS study (NCT05371613), a larger-scale trial pinning the agent against idursulfase for up to a 96-week treatment period.
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy
Jan 9, 2025 · Denali expects to submit a Biologics License Application (BLA) for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway.
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Desi
SOUTH SAN FRANCISCO, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. ( DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for the treatment of individuals with Hunter syndrome (MPS II).