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Denali Therapeutics

SOUTH SAN FRANCISCO, CA · Biopharma, Biotechnology, Health Care · 567 employees

Denali Therapeutics is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier using its proprietary TransportVehicle™ platform. With a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, Denali Therapeutics is advancing toward its goal of delivering effective medicines to tra

Funding history

  • Series royalty agreement — $200.0M — Mar 2026
  • Funding Round — $160.0M — Dec 2025
  • Funding Round — $499.7M — Mar 2024

Recent signals

  • Jun 03, 2026: SEC 8-K (5.02): On June 3, 2026, Denali Therapeutics Inc. held its annual meeting of stockholders where three Class III directors were elected to serve until the 2029 annual meeting. A total of 137,986,127 out of 158,675,498 outstanding shares were represented at the meeting, demonstrating a significant level of shareholder engagement. This election solidifies the board's composition and strategic direction for the upcoming years, which could impact corporate governance and management processes moving forward.
  • May 21, 2026: SEC 8-K (7.01): On May 21, 2026, Denali Therapeutics Inc. and Biogen Inc. announced the topline results from the Phase 2b LUMA study, which evaluated BIIB122 (DNL151) in patients with early-stage Parkinson's disease. This study is significant as it explores a potential treatment avenue for a debilitating disease and the results could influence future treatment strategies and market opportunities. This press release is detailed as Exhibit 99.1 in the filing and offers insights into the drug's efficacy and safety as determined through clinical trials.
  • Apr 03, 2026: Denali Therapeutics Receives Notice of Termination from Takeda Pharmaceutical
  • Apr 03, 2026: SEC 8-K (1.02): On April 3, 2026, Denali Therapeutics Inc. received written notice from Takeda Pharmaceutical Company Limited regarding the termination of their Collaboration Agreement, initially dated January 3, 2018, for the co-development and co-commercialization of DNL593. The termination decision, influenced by strategic considerations, will take effect 60 days from the notice date, reverting all rights in the DNL593 program back to Denali. Following this termination, Denali will not have any further financial obligations to Takeda, which may enhance its strategic positioning and financial efficiency moving forward.
  • Apr 03, 2026: SEC 8-K (1.02): On April 3, 2026, Denali Therapeutics Inc. received written notice from Takeda Pharmaceutical Company Limited regarding the termination of their Collaboration Agreement established on January 3, 2018, aimed at co-developing DNL593. The decision for termination arises from strategic considerations rather than any efficacy or safety concerns. This termination will take effect 60 days from the notice date, leading to all rights associated with the DNL593 program being transferred back to Denali, and relieving them of any further financial obligations to Takeda. This event may impact Denali's strategic direction and financial planning moving forward.
  • Mar 31, 2026: Raised $200.0M in Series royalty agreement
  • Mar 27, 2026: SEC 8-K (2.01): Denali Therapeutics Inc. completed a significant transaction under a synthetic royalty funding agreement with Royalty Pharma on March 27, 2026. The Company received $200.0 million in gross proceeds stemming from this agreement, which is directly linked to the accelerated approval of its product tividenofusp alfa by the U.S. Food and Drug Administration on March 24, 2026. This strategic funding is expected to enhance the Company's financial flexibility and support further development of their therapeutic product. The transaction demonstrates a clear alignment of Denali's corporate strategies with regulatory milestones, marking a pivotal moment for the Company and its future endeavors.
  • Mar 25, 2026: SEC 8-K (7.01): On March 25, 2026, Denali Therapeutics Inc. announced the approval of AVLAYAH TM (tividenofusp alfa) by the U.S. Food and Drug Administration. This treatment is intended for patients with Hunter syndrome (MPS II), specifically focusing on pediatric patients weighing at least 5 kg who are presymptomatic or symptomatic, prior to advanced neurologic impairment. This approval could significantly impact treatment options available for this patient population, enhancing the company's portfolio in the rare disease space. The strategic implications include potential revenue growth resulting from this newly approved therapy as it fills a critical treatment gap in the market.

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