regulatory
confidence high
sentiment positive
materiality 0.75
Prelude Therapeutics gets FDA clearance to start Phase 1 trial of PRT13722 for HR+ breast cancer
Prelude Therapeutics Inc
- FDA cleared IND for PRT13722, an oral KAT6A selective degrader, for HR+/HER2- breast cancer.
- Phase 1 study expected to begin enrolling patients in Q4 2026.
- Study will evaluate PRT13722 as monotherapy and in combination with endocrine and targeted therapies in adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer.
- Company believes selective KAT6A degradation may improve efficacy and hematological safety vs dual KAT6A/B inhibitors.