Expanded Access Policy
Position Statement on Expanded Access to Investigational Medicines
Last updated: August 2026
Our Commitment to Patients with Graves’ Disease and Thyroid Eye Disease
Yarrow Bioscience, Inc. (“Yarrow”) is a clinical-stage biopharmaceutical company dedicated to rapidly and directly disrupting the central mechanism that drives Graves’ disease (GD) and thyroid eye disease (TED). Our lead candidate, YB-101, is designed to selectively bind the TSH receptor and block its activation by the autoantibodies responsible for disease progression, with the goal of restoring balance for patients who currently have few options beyond therapies with serious toxicities or irreversible procedures.
We recognize that patients living with GD and TED, and the physicians who treat them, are often searching urgently for any avenue that might help. This statement explains our current position on expanded access (sometimes called “compassionate use”) to YB-101 outside of our clinical development program, consistent with our obligations under Section 561A of the Federal Food, Drug, and Cosmetic Act, as added by the 21st Century Cures Act.
Current Policy: Expanded Access Is Not Being Offered
At this stage of development, Yarrow has made the decision not to make YB-101 available through an expanded access program. YB-101 is still being evaluated in controlled clinical trials designed to establish safety and efficacy data to support regulatory approval required before a medicine can be made broadly available. Our top priority is to direct full resources toward generating the necessary evidence to bring YB-101 to the greatest number of eligible patients, safely and as quickly as possible. We will continue to revisit our expanded access position as our clinical program matures.
What This Means for Patients Today
Patients and physicians interested in YB-101 are encouraged to explore enrollment in one of Yarrow’s ongoing clinical trials. Participating in a clinical trial remains the most direct way to access YB-101 today, and it also contributes to the data that will ultimately support regulatory review.
Current studies include:
• A global Phase 2a/2b trial of YB-101 in patients with Graves’ disease, with or without TED.
View trial record on ClinicalTrials.gov (NCT07682896)
Additional Phase 1 studies of YB-101 are being conducted in China by our partner GenSci in both Graves’ disease and thyroid eye disease. Details on all studies, including eligibility criteria and enrolling sites, are available at ClinicalTrials.gov or by speaking with a treating physician.
This Policy May Change
Yarrow will periodically reassess this position as YB-101 advances through clinical development, and reserves the right to revise this statement, including a decision to offer expanded access in the future, at any time. Any change will be reflected on this page.
How to Reach Us
Patients, caregivers, and healthcare professionals with questions about YB-101, our clinical trials, or this policy may contact us at:
Yarrow Bioscience, Inc. 470 James Street, Suite 007 New Haven, CT 06513
Requests specific to expanded access under Section 561(b) of the FD&C Act should be submitted in writing by the patient’s treating physician to the address above, or by email, so that our medical team can respond appropriately.
Additional Resources
For general information on expanded access and other investigational medicines, visit the FDA/Reagan-Udall Foundation Expanded Access Navigator at navigator.reaganudall.org. Yarrow is also proud to partner with the Graves’ Disease and Thyroid Foundation (gdatf.org) to support patient education.
This statement is issued in accordance with Section 561A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb-0), as added by the 21st Century Cures Act and amended by the FDA Reauthorization Act of 2017.