---
schema_version: "secwatch.filing_event.v1"
accession: "0001725160-25-000013"
form_type: "8-K"
ticker: "ZNTL"
cik: "0001725160"
company_name: "Zentalis Pharmaceuticals, Inc."
filed_at: "2025-01-29T23:59:59+00:00"
generated_at: "2026-05-27T07:07:42.268451+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Zentalis reports azenosertib ORR 34.9% in Cyclin E1+ PROC; FDA aligned on DENALI Part 2 for accelerated approval path

## Summary
- DENALI Part 1b in Cyclin E1+ PROC achieved 34.9% ORR (response-evaluable n=43) and ~5.5 months median DOR; ITT ORR 31.3%.
- FDA aligned on seamless DENALI Part 2 design; enrollment to begin 1H 2025 with topline data by year-end 2026; potential accelerated approval.
- MAMMOTH monotherapy in Cyclin E1+ patients at 400mg QD 5:2 showed 31.3% ORR (n=16); safety profile well-characterized with low discontinuation rate.
- Company discontinues ZN-c3-016 (BRAF CRC expansion) due to resource prioritization; no further development of niraparib combination.
- Corporate restructuring extended cash runway into late 2027, beyond expected DENALI Part 2 data readout.

## SEC filing metadata
- accession: 0001725160-25-000013
- form_type: 8-K
- ticker: ZNTL
- cik: 0001725160
- company_name: Zentalis Pharmaceuticals, Inc.
- filed_at: 2025-01-29T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1725160/000172516025000013/0001725160-25-000013-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1725160/000172516025000013/zntl-20250129.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001725160-25-000013
- JSON: https://secwatch.observer/filing/0001725160-25-000013.json
- Plain text: https://secwatch.observer/filing/0001725160-25-000013.txt

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