---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-099482"
form_type: "8-K"
ticker: "BCYC"
cik: "0001761612"
company_name: "BICYCLE THERAPEUTICS PLC"
filed_at: "2023-09-11T23:59:59+00:00"
generated_at: "2026-06-10T21:47:37.878013+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Bicycle Therapeutics aligns with FDA on Phase 2/3 registrational trial for BT8009 in metastatic bladder cancer

## Summary
- FDA alignment reached on Duravelo-2 trial design; trial to begin Q1 2024.
- Potential accelerated approval based on ORR, with PFS to confirm benefit.
- Cohort 1: BT8009 + pembrolizumab in untreated metastatic bladder cancer.
- Cohort 2: BT8009 monotherapy and combo in previously treated patients.
- Discussions ongoing for confirmatory trial design in second-line-plus setting.

## SEC filing metadata
- accession: 0001104659-23-099482
- form_type: 8-K
- ticker: BCYC
- cik: 0001761612
- company_name: BICYCLE THERAPEUTICS PLC
- filed_at: 2023-09-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1761612/000110465923099482/0001104659-23-099482-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1761612/000110465923099482/tm2325810d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-099482
- JSON: https://secwatch.observer/filing/0001104659-23-099482.json
- Plain text: https://secwatch.observer/filing/0001104659-23-099482.txt

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