Tividenofusp alfa

Denali Therapeutics received FDA Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for Hunter syndrome, planning a Biologics License Application by early 2025. Despite a Phase 2/3 trial miss for ALS treatment DNL343, Denali's neurodegenerative disease platform and LRRK2 inhibitor BIIB122 for Parkinson’s show promise. Analysts remain optimistic, with upgrades and a focus on the company's innovative transport vehicle technology.

The FDA granted breakthrough therapy designation to tividenofusp alfa for Hunter syndrome, showing promise in phase 1/2 trials with improved clinical outcomes and safety. A phase 2/3 trial, COMPASS, is enrolling to further evaluate its efficacy and safety.

Denali Therapeutics plans to submit a Biologics License Application for tividenofusp alfa, targeting Hunter syndrome, in early 2025 under accelerated approval. The FDA granted it Breakthrough Therapy Designation, highlighting its potential to improve treatment outcomes significantly. Tividenofusp alfa aims to address both physical and cognitive symptoms of Hunter syndrome, a rare genetic disease.

Stifel analysts maintain a Buy rating on Denali Therapeutics with a $37 target, following FDA's Breakthrough Therapy Designation for DNL310 for Hunter Syndrome. Despite negative earnings, the stock is seen as undervalued, with potential for accelerated approval by 2025. Denali's strong financials and promising treatments for Hunter and Sanfilippo Syndromes, estimated at over $1 billion market, support optimism despite recent trial setbacks.

Denali Therapeutics Inc. received FDA Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for Hunter syndrome treatment, adding to previous designations. Plans to submit a BLA in early 2025 aim for accelerated approval, with the designation facilitating expedited development and review.

Denali Therapeutics' tividenofusp alfa received FDA Breakthrough Therapy Designation for Hunter syndrome, adding to previous designations. A Biologics License Application is expected by early 2025 for accelerated approval.

Denali Therapeutics received FDA Breakthrough Therapy Designation for tividenofusp alfa, targeting Hunter syndrome. The drug aims to address both neurological and physical symptoms, with a Biologics License Application expected soon. Denali, valued at $3.05 billion, focuses on neurodegenerative diseases and lysosomal storage disorders.

Denali Therapeutics received FDA Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for Hunter syndrome (MPS II) treatment, aiming to address both brain and body symptoms. Plans to submit a Biologics License Application in early 2025 under accelerated approval pathway. Tividenofusp alfa shows promise in Phase 1/2 study, targeting unmet needs in Hunter syndrome therapy.

Denali Therapeutics Inc. announced FDA Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for Hunter syndrome treatment, highlighting its potential to address the disease's full spectrum. The designation aims to expedite development and review, with Denali planning a Biologics License Application submission in early 2025. Tividenofusp alfa, designed to optimize enzyme delivery to brain and body, has shown promising results in Phase 1/2 studies.