Prelude Therapeutics Announces FDA Clearance to Begin Phase 1 Trial

What Happened

• Prelude Therapeutics, Inc. (PRLD) filed a Form 8-K on September 10, 2026 (Item 7.01) announcing that the U.S. Food and Drug Administration cleared the company to proceed with a Phase 1 clinical study under its Investigational New Drug (IND) application for PRT13722, a KAT6A degrader being developed for patients with hormone receptor–positive (HR+) breast cancer.
• The filing includes a press release (Exhibit 99.1) and investor presentation materials to be used by management (Exhibit 99.2). The disclosure was furnished under Regulation FD and is expressly noted as “furnished, but not filed” for purposes of the securities laws. The 8-K was signed by Bryant Lim, Chief Financial Officer and Chief Legal Officer.

Key Details

• FDA action: IND cleared to begin a Phase 1 study for PRT13722 (KAT6A degrader).
• Indication: HR+ (hormone receptor–positive) breast cancer.
• Filing date: Form 8-K filed September 10, 2026; press release dated September 10, 2026 (Exhibit 99.1).
• Corporate note: Investor presentation attached as Exhibit 99.2; information furnished under Regulation FD and not incorporated by reference into other filings.

Why It Matters

• This is a clinical development milestone: FDA clearance to start a Phase 1 trial allows Prelude to begin human testing of PRT13722, advancing the program from preclinical/IND stage into clinical evaluation.
• For investors, clinical starts are typical near‑term catalysts that can lead to future updates (enrollment, safety, early efficacy readouts) and subsequent regulatory filings.
• The company’s disclosure is informational (furnished, not filed), so investors should watch for subsequent filings or press releases with trial details, timelines, and results.