3 hours ago
Phase 2/3 Duravelo-2 pivotal trial evaluating zelenectide pevedotin (zelenectide) plus pembrolizumab in metastatic urothelial cancer (mUC) successfully identifies 6mg/m2 zelenectide two weeks on, one week off dose (6mg dose) as optimal, demonstrating response rates comparable to published rates for standards of care with a differentiated tolerability profile
Bicycle to convert Duravelo-2 to a randomized Phase 2 trial while determining appropriate next steps for the program
Strategic reprioritization to focus on BT5528 and next generation Bicycle® conjugates, including Bicycle® Radioconjugates (BRC®); additional EphA2 human imaging data and Phase 1 BT5528 combination data planned for the first half of 2026
Strategic partnerships established to enable an end-to-end isotope agnostic strategy to support the potential discovery, development and commercial supply of a portfolio of BRCs
Cash and cash equivalents of $628 million as of December 31, 2025, with expected cash runway extended into 2030 following a strategic reprioritization, including a proposed workforce reduction of approximately 30%
CAMBRIDGE, England & BOSTON, March 17, 2026--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided recent corporate updates.
"We have successfully completed the dose selection portion of the Duravelo-2 trial and received regulatory alignment that the 6mg dose and schedule is optimal for zelenectide in mUC based on strong anti-tumor activity and its differentiated safety profile. We look forward to sharing these data at an upcoming scientific conference. Based on the regulatory feedback we have received, the existing Duravelo-2 trial design is no longer considered acceptable as an approval path for zelenectide in mUC. Preliminary discussions with regulatory agencies have outlined several potential paths for zelenectide’s approval in mUC. While we believe the strength of these data and the clear medical need justify continued development of zelenectide, we have reached the difficult decision to deprioritize this program for internal development at this time. We have initiated a process to convert our ongoing Duravelo-2 trial to a randomized Phase 2 study. Once we have these randomized Phase 2 data in hand, we will determine the most appropriate path for zelenectide," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "We believe these data provide further validation of the ability of our Bicycle technology to deliver oncology therapeutics with a potentially improved benefit/risk profile compared to existing modalities. In view of this, we have decided to conduct a strategic reprioritization, which includes a proposed workforce reduction, to best position the company to focus our resources on our promising pipeline of next-generation therapeutics."
