Tividenofusp alfa

Denali Therapeutics Inc received FDA Breakthrough Therapy Designation for tividenofusp alfa (DNL310), targeting Hunter syndrome. Positive Phase 1/2 study results and innovative Enzyme TransportVehicle™ technology highlight its potential. Denali plans a Biologics License Application submission in early 2025, aiming for accelerated approval despite inherent clinical and regulatory risks.

Jefferies maintains a Buy rating on Denali Therapeutics with a $45 target, despite ALS trial miss. Stock at $19.82, seen undervalued. Denali's DNL310 for Hunter Syndrome aims for 2025 approval. Positive data for DNL126 for Sanfilippo Syndrome noted. Financials strong, with 9.98 current ratio, minimal debt.

Baird rates Denali Therapeutics (DNLI) Outperform with a $31 target, predicting FDA approval for tividenofusp alfa by late 2025/early 2026. DNL310, targeting Hunter syndrome, may capture significant market share from Elaprase. Denali's Alzheimer’s and Parkinson’s programs are seen as promising long-term opportunities.

BofA Securities lowered Denali Therapeutics' price target to $30 from $34, maintaining a Buy rating, after DNL343 failed phase 2/3 ALS trial endpoints. Despite this, optimism remains for Denali's brain delivery platform and financial health, with a pivotal 2025 expected for its Hunter syndrome treatment. Denali's stock is seen as undervalued, offering a potential buying opportunity.

William Blair initiates coverage on Denali Therapeutics, highlighting its specialized transport vehicle platform for neurodegenerative diseases. With a lead program showing promise and plans for accelerated approval, Denali's market cap is $2.93B, with potential for significant growth and valuation increases as clinical data reduces risks.

Denali Therapeutics Inc. announced FDA Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for Hunter syndrome treatment, highlighting its potential to address both brain and body symptoms. The designation aims to expedite development, with a Biologics License Application expected in early 2025. Tividenofusp alfa targets the disease's cognitive, behavioral, and physical symptoms, representing a significant advancement over current treatments.

Denali Therapeutics Inc. DNLI started dosing in the BEACON study for BIIB122, targeting LRRK2-associated Parkinson’s disease. Shares rose 8.7% YTD. The phase IIa study assesses BIIB122's safety and biomarkers in 50 participants, funded by a $75M agreement. Denali also progresses with DNL310 for Hunter syndrome and DNL343 for ALS, planning a BLA for DNL310.

FDA and Denali Therapeutics agreed on cerebrospinal fluid heparan sulfate as a surrogate endpoint for DNL310's accelerated approval in treating Hunter syndrome. DNL310 showed a 90% reduction in CSF HS, with sustained effects and safety. Phase 1/2 data revealed improvements in clinical outcomes, supporting its development. A BLA submission is planned for early 2025.

Denali Therapeutics plans to file for accelerated approval of DNL310 for MPSII (Hunter Syndrome) treatment, following positive FDA discussions. The company aims for a biologics license application (BLA) submission in early 2025, leveraging CSF HS as a surrogate biomarker, and anticipates full approval post-global Phase 2/3 COMPASS study completion.