Bicycle Therapeutics plans dose selection update in first quarter 2026

Bicycle Therapeutics plc (NASDAQ: BCYC) announced its strategic priorities for 2026, including an expected dose selection update from its Phase 2/3 Duravelo-2 trial and potential approval pathway information for zelenectide pevedotin in the first quarter of 2026.

The company plans to seek feedback from multiple regulatory agencies regarding the potential approval pathway for zelenectide pevedotin, which targets Nectin-4 for metastatic urothelial cancer treatment.

In 2025, Bicycle Therapeutics initiated two new clinical trials: the Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer and the Phase 1/2 Duravelo-4 trial for NECTIN4-amplified non-small cell lung cancer. Initial data from the Duravelo-3 trial is expected in the second half of 2026.

The company reported human imaging data for early Bicycle Radioconjugate molecules targeting EphA2 and MT1-MMP during 2025. Additional EphA2 human imaging data is planned for the first half of 2026.

Bicycle Therapeutics established supply chain collaborations with the United Kingdom Nuclear Decommissioning Authority, United Kingdom National Nuclear Laboratory and SpectronRx for 212Pb radiopharmaceuticals, adding to existing supply chains for 177Lu and 68Ga radioisotopes.

The company expects its financial runway to extend into 2028 to support clinical and strategic priorities. Other planned 2026 milestones include reporting dose selection data from the Duravelo-2 trial, additional Phase 1 combination data, and Phase 1 data for BT5528 and BT7480 compounds.

Information is based on a company press release.

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