FDA Events for Prelude Therapeutics (PRLD)
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
PRT3789. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PRT3789 - FDA Regulatory Timeline and 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.
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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 PRT3789.
The most recent FDA-related event for Prelude Therapeutics occurred on September 9, 2024, involving PRT3789. The update was categorized as "Abstract," with the company reporting: "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."
Currently, Prelude Therapeutics has one therapy (PRT3789) targeting the following condition: In Patients with Advanced Solid Tumors with a SMARCA4 Mutation..
More FDA Event Resources from MarketBeat
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
This page (NASDAQ:PRLD) was last updated on 7/12/2025 by MarketBeat.com Staff
