ETX-636 Granted Fast Track Designation by the FDA for Advanced Breast Cancer

“Patients with advanced HR+/HER2- breast cancer harboring PIK3CA mutations have poor prognosis, and there is an unmet need for therapies targeting this population that are safer and more efficacious than the current FDA approved non-mutant selective treatments,” said Dr. Shengfang Jin, CEO and Co-Founder of ENSEM. “We are appreciative that the FDA has recognized ETX-636 as a potentially important treatment for this indication and we remain laser-focused on demonstrating its benefit to patients in our current clinical trials.”

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