At Yoltech Therapeutics, we are committed to developing innovative therapies for patients with serious diseases. Section 561A of the Federal Food, Drug, and Cosmetic Act (the “Cures Act”) requires companies developing investigational medicines to make their policy on Expanded Access publicly available.
Expanded Access (sometimes called “compassionate use”) is a potential pathway that allows patients to access an investigational drug outside of a clinical trial when they have a serious or life-threatening condition and no other treatment options are available.
Current Expanded Access Status
At this time, Yoltech Therapeutics has no immediate plans to offer Expanded Access to any of its investigational products.
Our investigational therapies are currently in clinical development, and we believe that participation in controlled clinical trials is the most appropriate and responsible way for patients to access these products. Clinical trials help ensure that we collect the safety and efficacy data needed to advance our medicines toward regulatory approval.
Future Updates
As our programs progress, we will review this policy on an ongoing basis. If Expanded Access becomes available in the future, we will update this webpage with instructions on eligibility criteria and how healthcare providers may submit requests.
Clinical Trial Information
Patients, caregivers, and healthcare professionals interested in learning more about clinical trials for our investigational therapies may contact us at:
Email: info@yoltx.com
Last Updated: 2026-01-29