secwatch / observer

8-K filed May 21, 2026, 5:05 PM ET ticker BCYC CIK 0001761612

other material confidence high sentiment positive materiality 0.80

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

BICYCLE THERAPEUTICS PLC

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.

item 8.01 item 9.01

Machine-readable event card

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
discovered_at: 2026-05-21T21:08:00.264922+00:00
generated_at: 2026-05-21T21:14:37.101880+00:00
sec_items: ["8.01", "9.01"]
event_type: other_material
sentiment: positive
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: high
secwatch_canonical_url: https://secwatch.observer/filing/0001104659-26-065231
json_url: https://secwatch.observer/filing/0001104659-26-065231.json
markdown_url: https://secwatch.observer/filing/0001104659-26-065231.md
text_url: https://secwatch.observer/filing/0001104659-26-065231.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/1761612/000110465926065231/0001104659-26-065231-index.htm
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generated_by_model: deepseek-v4-flash:cloud@v2
review_status: machine_generated
human_reviewed: false
corrected: false
correction_note: null
correction_timestamp: null
superseded_by: null

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