Denali Therapeutics believes that the goal of making life-changing medicines available to the patient community is achieved through well-designed clinical studies followed by regulatory approval. The best way to access a medicine which has not yet received regulatory marketing approval, i.e. an investigational medicine, is through participation in a clinical study. Denali Therapeutics understands that not all patients are able to participate in a clinical study, and other treatment options may have been exhausted. In those cases, the individual’s treating physician may choose to request access to an investigational medicine outside of a clinical study via what is termed early access program. Currently, however, participation in clinical studies is the only way to gain access to Denali’s investigational medicines.

While we recognize the disappointment this may bring, at Denali, we are doing all we can to complete clinical studies that are both robust and expeditious to secure approval and access for all patients in need. As more clinical data on the safety and efficacy of these investigational medicines become available, we will review and potentially revise our early access program.