Upcoming FDA Events for Prelude Therapeutics
Prelude Therapeutics (PRLD) has upcoming FDA regulatory milestones for PRT13722. The table below outlines estimated target dates and event types for these pending regulatory actions.
Prelude Therapeutics' Drug in the FDA Approval Process
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. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PRT13722 FDA Regulatory Timeline and 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:
- September 10, 2026
- Target Action Date:
- Q4 2026
- Estimated Target Date Range:
- October 1, 2026 - December 31, 2026
- Indication:
- Oral KAT6A Selective Degrader
Announcement
Prelude Therapeutics Incorporated announced that the Company expects to begin enrolling patients in the fourth quarter of 2026.
Read Announcement- Drug:
- PRT13722
- Announced Date:
- September 10, 2026
- Indication:
- Oral KAT6A Selective Degrader
Announcement
Prelude Therapeutics announced that the U.S. Food and Drug Administration (FDA) cleared the Company to proceed with a Phase 1 study under its Investigational New Drug Application (IND) for PRT13722, an oral KAT6A selective degrader being developed for the treatment of patients with HR+/HER2- breast cancer.
Read Announcement- 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).”
Read Announcement
Prelude Therapeutics FDA Events - Frequently Asked Questions
As of now, Prelude Therapeutics (PRLD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Prelude Therapeutics (PRLD) has reported FDA regulatory activity for PRT13722.
The most recent FDA-related event for Prelude Therapeutics occurred on September 10, 2026, involving PRT13722. The update was categorized as "FDA Clearance," with the company reporting: "Prelude Therapeutics announced that the U.S. Food and Drug Administration (FDA) cleared the Company to proceed with a Phase 1 study under its Investigational New Drug Application (IND) for PRT13722, an oral KAT6A selective degrader being developed for the treatment of patients with HR+/HER2- breast cancer."
Currently, Prelude Therapeutics has one therapy (PRT13722) targeting the following condition: Oral KAT6A Selective Degrader.
More FDA Event Resources from MarketBeat
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:PRLD last updated on 9/10/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
