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Wire · opportunities

Prelude Therapeutics Receives FDA Clearance of Investigational New Drug (IND ...

10 September 2026 · By · Wire by Fusion42

Published

10 September 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at biospace.com →

◆ Verified

Fusion42 · 10 September 2026 · Fusion42 review

Prelude Therapeutics has received FDA clearance for its Investigational New Drug application to commence a Phase 1 clinical trial of PRT13722, a first-in-class oral selective degrader targeting KAT6A, for treating HR+/HER2- breast cancer, with patient enrolment expected in Q4 2026.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

You can now focus on clinical validation for this novel breast cancer therapy, as FDA clearance opens patient enrolment and market entry pathways in the US. This early-stage regulatory green light means your oncology drug development plans can align with priority patient trials and funding strategies.

◆ Coverage

1 source · 10 Sep 2026

◆ Related on Wire

◆ Topics

BiotechFDA-clearancedrug-developmentprecision-oncologyKAT6Abreast-cancer