Cogent Biosciences’ Expanded Access Policy

Cogent Biosciences Inc. (Cogent) is a clinical-stage biotechnology company developing novel precision therapies to treat genetically defined diseases.

Expanded access is a potential option for a patient to gain access to an investigational product outside of a clinical study. In line with guidelines from the US FDA and other regulatory agencies, expanded access may be appropriate when all of the following criteria are met:

  • A patient has a serious or life-threatening condition with no other satisfactory treatment options;
  • There is sufficient evidence that the potential patient benefit justifies the potential risks of treatment;
  • Clinical study enrollment is not possible for the patient; and
  • Provision of the investigational product via expanded access will not interfere with clinical studies that could support product development and marketing approval.

Cogent believes that participation in a clinical study is the most appropriate way to access investigational therapies.

The only expanded access program available for PLX9486 is for subjects previously treated in the PLX121-01 study to enable continued treatment after study completion. 

Requests can only be made by a treating physician and should be sent to Receipt of this request will be acknowledged within five business days. 

Consistent with the 21st Century Cures Act, Cogent may revise this policy at any time.