secwatch.observer — SEC 8-K summary
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Issuer:     BICYCLE THERAPEUTICS PLC (BCYC)
CIK:        0001761612
Form:       8-K
Filed at:   2026-05-21T21:05:25+00:00
Accession:  0001104659-26-065231
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1761612/000110465926065231/0001104659-26-065231-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1761612/000110465926065231/tm2615187d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-065231

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer