---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-065231"
form_type: "8-K"
ticker: "BCYC"
cik: "0001761612"
company_name: "BICYCLE THERAPEUTICS PLC"
filed_at: "2026-05-21T21:05:25+00:00"
generated_at: "2026-05-21T21:14:37.101880+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Bicycle Therapeutics reports positive Duravelo-2 mUC data with lower toxicity vs SOC

## Summary
- Zelenectide + pembrolizumab: 58% confirmed ORR (15/26) at optimal dose in first-line mUC; 62% with later response.
- Low adverse events: peripheral neuropathy 33%, skin reactions 17%, no Grade 4/5; only 1 discontinuation due to AE.
- Updated Duravelo-1: median PFS 13.0 months in cisplatin-ineligible patients on zelenectide + pembrolizumab.
- Further Phase 2 Duravelo-2 data from randomized trial expected in 2H 2026.

## SEC filing metadata
- accession: 0001104659-26-065231
- form_type: 8-K
- ticker: BCYC
- cik: 0001761612
- company_name: BICYCLE THERAPEUTICS PLC
- filed_at: 2026-05-21T21:05:25+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1761612/000110465926065231/0001104659-26-065231-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1761612/000110465926065231/tm2615187d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-065231
- JSON: https://secwatch.observer/filing/0001104659-26-065231.json
- Plain text: https://secwatch.observer/filing/0001104659-26-065231.txt

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