Denali Therapeutics (NASDAQ:DNLI) shares are down on Monday as the company announced it has regained full rights to its investigational therapy DNL593 from Takeda Pharmaceutical Co. Ltd. (NYSE:TAK)

Takeda Ends Drug Partnership For Strategic Reasons

Takeda on Friday notified Denali Therapeutics regarding the termination of their collaboration agreement to co-develop DNL593, a progranulin replacement therapy for frontotemporal dementia.

The decision is strategic and not related to efficacy or safety data, allowing Denali to regain full control over the therapy and its intellectual property.

Biomarker Results Expected By End Of 2026

“While we have greatly valued our partnership, we are pleased to regain full ownership of DNL593. We remain confident in the scientific rationale and the data generated to date, and we look forward to advancing DNL593 independently. We plan to report results from the ongoing Phase 1/2 trial by the end of 2026,” said Ryan Watts, CEO of Denali Therapeutics

Early Data Show Dose-Dependent Progranulin Increases

Enrollment in this study was completed with a total of 40 participants with FTD-GRN.

Interim results from Part A of the Phase 1/2 study in healthy volunteers demonstrated dose-dependent increases in cerebrospinal fluid progranulin levels, consistent with robust brain delivery of DNL593.

DNL593 was generally well tolerated, and there have been no significant safety signals to date.

In March, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Denali’s Avlayah (tividenofusp alfa-eknm) as the first FDA-approved biologic to cross the blood-brain barrier and reach the whole body, including the brain.

In December 2025, the FDA placed a clinical hold on Denali’s investigational new drug application for the Phase 1 study of DNL952 under development for Pompe disease.

The FDA requested a protocol amendment to include a lower starting dose, revised inclusion criteria, certain safety monitoring commitments, and stopping rules.

Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $34.83. Recent analyst moves include:

  • Morgan Stanley: Overweight (Raises Target to $42.00) (March 26)
  • Goldman Sachs: Buy (Raises Target to $40.00) (March 26)
  • Stifel: Buy (Raises Target to $41.00) (March 26)

DNLI Price Action: Denali Therapeutics shares were down 3.73% at $19.88 at the time of publication on Monday, according to Benzinga Pro data.

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