"Armistice Capital and other institutional investors increased Bicycle Therapeutics positions during 2025. Investors maintained exposure to the clinical-stage biopharmaceutical company ahead of regulatory milestones. Bicycle Therapeutics announced in January 2026 that the company expects to provide dose selection updates and potential approval pathway information for zelenectide pevedotin following meetings with multiple regulatory agencies during the first quarter. The Cambridge, UK-based biopharmaceutical company is seeking regulatory feedback on its lead drug candidate targeting metastatic urothelial cancer."
"Bicycle Therapeutics is conducting the Phase 2/3 Duravelo-2 registrational trial evaluating zelenectide pevedotin in combination with pembrolizumab versus chemotherapy in first-line metastatic urothelial cancer, alongside evaluations of zelenectide pevedotin monotherapy and combination therapy in late-line patients. Updated Phase 1 Duravelo-1 data presented in January 2025 showed a 60% overall response rate among 20 evaluable first-line cisplatin-ineligible patients with metastatic urothelial cancer receiving zelenectide pevedotin plus pembrolizumab. The treatment demonstrated what the company characterized as a differentiated safety profile, with all Grade 3 treatment-related adverse events proving reversible and no patient withdrawals due to zelenectide-related adverse events."
"Third-quarter 2025 revenue totalled $11.73 million, exceeding consensus estimates of $8.25 million. The company reported a net loss of $59.1 million, or $0.85 per share, compared to a net loss of $50.8 million in the same period of 2024. "We are currently seeking broad regulatory feedback to make an informed decision on our path forward with zelenectide pevedotin in metastatic urothelial cancer," CEO Kevin Lee said in October 2025. The company initiated Phase 1/2 Duravelo-3 and Duravelo-4 trials during 2025, expanding"
Bicycle Therapeutics pursued regulatory feedback and expects to provide dose selection updates and potential approval pathway information for zelenectide pevedotin after early-2026 agency meetings. The company is evaluating zelenectide pevedotin in the Phase 2/3 Duravelo-2 registrational trial in combination with pembrolizumab versus chemotherapy in first-line metastatic urothelial cancer, and is testing monotherapy and combination regimens in later-line patients. Updated Phase 1 Duravelo-1 data showed a 60% overall response rate in 20 evaluable first-line cisplatin-ineligible patients with a reversible Grade 3 adverse-event profile and no zelenectide-related withdrawals. Revenue in Q3 2025 was $11.73 million while net loss widened to $59.1 million; Phase 1/2 Duravelo-3 and Duravelo-4 trials were initiated during 2025.
#zelenectide-pevedotin #metastatic-urothelial-cancer #clinical-trials #regulatory-milestones #investor-activity
Read at London Business News | Londonlovesbusiness.com
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