This section highlights FDA-related milestones and regulatory updates for drugs developed by Prelude Therapeutics (PRLD).
Over the past two years, Prelude Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PRT13722 and PRT3789. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
PRT13722 FDA Regulatory Events
PRT13722 is a drug developed by Prelude Therapeutics for the following indication: Oral KAT6A Selective Degrader.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PRT13722
- Announced Date:
- April 20, 2026
- Indication:
- Oral KAT6A Selective Degrader
Announcement
relude Therapeutics announced the presentation of new preclinical data from its lead development candidate, PRT13722. PRT13722 is being developed for the treatment of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 (HER2-) breast cancer (BC).
AI Summary
Prelude Therapeutics announced new preclinical data for PRT13722, its lead candidate for hormone receptor–positive (HR+)/HER2‑negative breast cancer. PRT13722 is a first-in-class, potent and selective oral KAT6A degrader. In multiple cell-derived (CDX) and patient-derived (PDX) tumor models of HR+/HER2‑ breast cancer, PRT13722 produced complete tumor regressions as a monotherapy and showed an improved preclinical hematological safety profile. These results suggest the drug may offer differentiated efficacy and a better blood-related safety profile compared with existing approaches. If these findings hold in humans, PRT13722 could address unmet needs by combining strong anti-tumor activity with lower hematologic toxicity.
Prelude presented the data at a scientific meeting and says it remains on track to file an Investigational New Drug (IND) application by mid-2026 and to start a clinical trial in the second half of 2026 as it advances PRT13722 toward human testing.
Read Announcement- Drug:
- PRT13722
- Announced Date:
- March 17, 2026
- Indication:
- Oral KAT6A Selective Degrader
Announcement
Prelude Therapeutics announced that a poster with preclinical data on the Company's oral KAT6A selective degrader (PRT13722) has been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place from April 17-22.
AI Summary
Prelude Therapeutics announced that a poster with preclinical data on its oral KAT6A selective degrader, PRT13722, has been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17–22. The poster will share early laboratory results supporting the compound’s potential as a targeted therapy for cancer.
The company previously presented initial preclinical findings at the AACR Annual Meeting 2025; related materials are available under Publications on Prelude Therapeutics’ website. The new poster is expected to expand on those data and outline next steps in preclinical development.
Additionally, on April 18, 2026, Norman Fultang, Ph.D., Prelude’s Director of Biology and Translational Research, will lecture in the educational session ED08 – “Chemistry to the Clinic Part 1 of 4: Next-Level Conjugates,” delivering a talk titled “Beyond Conventional Payloads: Unlocking New Therapeutic Landscapes with Targeted Protein Degrader-Antibody Conjugates (DACs).”
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PRT3789 FDA Regulatory Events
PRT3789 is a drug developed by Prelude Therapeutics for the following indication: In Patients with Advanced Solid Tumors with a SMARCA4 Mutation.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PRT3789
- Announced Date:
- September 9, 2024
- Indication:
- In Patients with Advanced Solid Tumors with a SMARCA4 Mutation.
Announcement
Prelude Therapeutics announced the publication of an abstract regarding PRT3789 at the European Society of Medical Oncology (ESMO) Congress 2024 taking place in Barcelona, Spain September 13-17, 2024.
AI Summary
Prelude Therapeutics announced the publication of an abstract on PRT3789 at the upcoming European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. The abstract highlights the first clinical data for this novel, highly selective SMARCA2 degrader, which is currently in Phase 1 trials. The study focuses on patients with advanced solid tumors harboring a SMARCA4 mutation—an area where treatment options are very limited. Early results from the trial suggest that PRT3789 is well-tolerated, shows promising target engagement, and has demonstrated signs of clinical activity, including tumor shrinkage and prolonged stable disease in some patients. These encouraging findings support further investigation of this first-in-class molecule. Updated data and additional insights will be presented during the congress from September 13 to 17, 2024.
Read Announcement
