Monitor Phase 1 enrollment updates and initial safety/efficacy data expected in 2027-2028. The favorable preclinical profile, particularly the 100% CR rate in refractory models and bone marrow sparing, supports the differentiation thesis. Any early signal of neurotoxicity or neutropenia would be a key de-risking event given competitor (prifetrastat) limitations against CDK4/6i combination.
Price Chart
Executive Summary
Prelude Therapeutics announced FDA clearance of its IND for PRT13722, a first-in-class oral KAT6A selective degrader for HR+/HER2- breast cancer. Phase 1 enrollment is expected to begin in Q4 2026. Preclinical data show >1000x selectivity over KAT6B, sub-nanomolar potency, durable complete regressions in treatment-refractory PDX models, and synergy with standard-of-care agents — positioning PRT13722 as a potential differentiated backbone therapy in a $40B+ addressable market.
Key Facts
- FDA cleared IND for PRT13722, a KAT6A selective degrader, on Sep 10, 2026
- Phase 1 first-in-human study in HR+/HER2- breast cancer expected to start enrolling in Q4 2026
- PRT13722 is >1,000-fold selective for KAT6A over KAT6B with sub-nanomolar DC50 (0.3 nM)
- Preclinically, PRT13722 achieved 100% complete response rates in CDK4/6i-refractory PDX models and demonstrated synergy with fulvestrant, CDK4/6 inhibitors, and PI3Kα inhibitors
- Company's cash runway expected into Q2 2028
- Incyte exclusive option agreement on JAK2 program provides additional capital flexibility
Financial Impact
IND clearance enables Phase 1 initiation of a potential best-in-class breast cancer therapy. No financial guidance or revenue impact is reported; the event enhances pipeline value.
Risk Factors
- Clinical development risk — Phase 1 safety and dose-finding may reveal unexpected toxicities
- Competitive landscape — multiple KAT6A/B inhibitors in development; differentiation must be proven clinically
- Dependence on successful enrollment and interim data for value inflection
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-387232 |
| Document: prld-ex99_2.htm | 0001193125-26-387232 |
| Document: prld-ex99_1.htm | 0001193125-26-387232 |
| Document: 0001193125-26-387232-index-headers.html | 0001193125-26-387232 |
| Document: 0001193125-26-387232-index.html | 0001193125-26-387232 |
| Document: 0001193125-26-387232.txt | 0001193125-26-387232 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 22, 2026 4w ago | Institutional Cluster | $4.85 $4.31 | ▼ −11.13% | ▼ −10.41% | $3.69 (−23.81%) |
Sep 10, 2026 6w ago | 8-K | $4.67 $4.59 | ▼ −1.71% | ▼ −2.57% | $3.69 (−20.88%) |
Sep 10, 2026 6w ago | Press Release | $4.67 $4.59 | ▼ −1.71% | ▼ −2.57% | $3.69 (−20.88%) |
Aug 11, 2026 11w ago | 8-K | $5.32 $5.73 | ▲ +7.71% | ▲ +7.46% | $3.69 (−30.55%) |
Aug 11, 2026 11w ago | Press Release | $5.32 $5.73 | ▲ +7.71% | ▲ +7.46% | $3.69 (−30.55%) |
May 12, 2026 24w ago | 8-K | $4.64 $4.66 | ▲ +0.43% | ▼ −0.14% | $3.69 (−20.37%) |
May 12, 2026 24w ago | Press Release | $4.64 $4.66 | ▲ +0.43% | ▼ −0.14% | $3.69 (−20.37%) |
Apr 28, 2026 25w ago | 3 | $4.27 $4.27 | · 0.00% | ▼ −1.02% | $3.69 (−13.47%) |
Apr 21, 2026 27w ago | Insider Cluster | $4.27 $5.23 | ▲ +22.48% | ▲ +21.46% | $3.69 (−13.47%) |
Apr 20, 2026 27w ago | 8-K | $4.51 $4.62 | ▲ +2.44% | ▲ +3.09% | $3.69 (−18.07%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers