Prelude Therapeutics says FDA cleared Phase 1 study of PRT13722 for HR+ breast cancer
Prelude Therapeutics said the U.S. Food and Drug Administration cleared its Investigational New Drug application for PRT13722, an oral KAT6A selective degrader, allowing a Phase 1 study in patients with HR+/HER2- breast cancer. The company expects to begin enrolling patients in the fourth quarter of 2026, so the filing marks a clinical milestone without any reported financial results.
Key points
- FDA cleared the company to proceed with a Phase 1 study under the IND for PRT13722.
- Enrollment is expected to begin in the fourth quarter of 2026.
- The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity in adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer.
- The company also furnished investor presentation materials as Exhibit 99.2, which management intends to use in investor presentations.
The filing
Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 10, 2026.
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