Bicycle Therapeutics said regulatory feedback forced it to abandon the accelerated approval path for its lead ADC zelenectide, converting a planned phase 2/3 registrational trial to phase 2 and discontinuing other early studies. Management announced a workforce reduction of roughly 30% to preserve cash into 2030 and refocus the pipeline. The move follows disappointing regulatory assessments that raised doubts about the asset’s place in a market already served by approved Nectin‑4 ADCs, and underscores how regulatory interactions can suddenly reshape mid‑stage biotech strategy and capital plans.
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