secwatch.observer — SEC 8-K summary
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Issuer:     BICYCLE THERAPEUTICS PLC (BCYC)
CIK:        0001761612
Form:       8-K
Filed at:   2023-12-14T23:59:59+00:00
Accession:  0001104659-23-125870
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Bicycle Therapeutics reports 38% ORR for BT8009, 39% ORR for BT5528 in mUC; plans Phase 2/3 trial in Q1 2024
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- BT8009 showed 38% ORR in 26 EV-naïve mUC patients; median duration of response 11.1 months; zero severe peripheral neuropathy.
- BT7480 demonstrated two unconfirmed partial responses in cervical cancer and three prolonged stable disease (≥7 months).
- BT5528 achieved 39% ORR in 18 mUC patients; median DOR 4 months; no bleeding events observed.
- Plans to initiate Phase 2/3 Duravelo-2 registrational trial for BT8009 in mUC in Q1 2024.
- Next-generation Bicycle conjugates in development; BRC imaging data expected in 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1761612/000110465923125870/0001104659-23-125870-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1761612/000110465923125870/tm2332810d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-125870

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