---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-034564"
form_type: "8-K"
ticker: "PRLD"
cik: "0001678660"
company_name: "Prelude Therapeutics Inc"
filed_at: "2026-02-03T23:59:59+00:00"
generated_at: "2026-05-16T05:21:01.746685+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA clears IND for Prelude's JAK2V617F inhibitor PRT12396; Phase 1 to start by Q2 2026

## Summary
- FDA cleared IND for PRT12396, a mutant-selective JAK2V617F inhibitor for myeloproliferative neoplasms.
- Phase 1 study in polycythemia vera and myelofibrosis to initiate by Q2 2026.
- PRT12396 is subject to an exclusive option agreement with Incyte (announced Nov 2025).
- JAK2V617F mutation drives ~95% of PV, 60% of ET, and 55% of MF cases.
- Open-label Phase 1 will assess safety, efficacy, and PK profile.

## SEC filing metadata
- accession: 0001193125-26-034564
- form_type: 8-K
- ticker: PRLD
- cik: 0001678660
- company_name: Prelude Therapeutics Inc
- filed_at: 2026-02-03T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1678660/000119312526034564/0001193125-26-034564-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1678660/000119312526034564/prld-20260129.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-034564
- JSON: https://secwatch.observer/filing/0001193125-26-034564.json
- Plain text: https://secwatch.observer/filing/0001193125-26-034564.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.