News Related to Denali Therapeutics

FDA Grants Accelerated Approval to First Therapy for Neurological Effects of Hunter Syndrome

Jun 15, 2026

The FDA has granted accelerated approval to Denali Therapeutics' Avlayah (tividenofusp alfa-eknm), the first therapy targeting neurological symptoms of Hunter syndrome. The approval was based on a surrogate endpoint measuring heparan sulfate reduction in cerebrospinal fluid, with confirmatory study results required for full approval. The global Hunter syndrome treatment market is projected to reach $2.6 billion by 2033.

Takeda shares draw valuation scrutiny after recent gains and mixed pipeline news

May 13, 2026

Takeda shares came under valuation scrutiny after recent gains and mixed pipeline news, including a DNL593 collaboration exit and positive Phase 3 data for zasocitinib. The analyses said the stock was trading close to or above widely followed fair value estimates, while DCF assumptions pointed to much higher implied value.

FDA Reversals on Rare Disease Drugs Spark Investor Uncertainty

Mar 07, 2026

The FDA has denied or discouraged at least eight drug applications in the past year, including treatments for rare diseases, raising concerns about regulatory consistency and the future of experimental therapies.