ACA Therapeutics Announces FDA Removal of Full Clinical Hold for ACA-001

New York, NY – April 6, 2026 – ACA Therapeutics, a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on ACA-001, an investigational combination therapy for patients with metastatic pancreatic cancer.

The FDA has concluded that the clinical trial may proceed.

This represents an important milestone for ACA Therapeutics, said Mike Zhou, M.D., CEO of ACA Therapeutics. “We are encouraged by the FDA’s feedback and look forward to advancing this program into clinical development.”

The Phase I study is designed to evaluate the safety and tolerability of ACA-001 in patients with advanced pancreatic cancer.

The removal of the clinical hold represents a significant de-risking step for the program and supports its continued clinical development.