Welcome to our dedicated page for Bicycle Therapeutics news (Ticker: BCYC), a resource for investors and traders seeking the latest updates and insights on Bicycle Therapeutics stock.
Bicycle Therapeutics plc develops clinical-stage medicines based on its proprietary bicyclic peptide, or Bicycle®, technology. Its updates center on oncology programs using fully synthetic constrained peptides, including nuzefatide pevedotin, a Bicycle Drug Conjugate targeting EphA2; zelenectide pevedotin, a Bicycle Drug Conjugate targeting Nectin-4; BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist targeting Nectin-4 and CD137; and Bicycle Radioconjugates for radiopharmaceutical use.
Recurring news includes clinical and preclinical data presentations, oncology pipeline updates, financial results, leadership changes, and collaborations that support radioisotope and radiopharmaceutical supply. Company announcements also discuss work with partners in additional therapeutic areas and the structure of its U.K. and U.S. operations.
Bicycle Therapeutics (NASDAQ:BCYC) reported initial Phase 2 Duravelo-2 and updated Phase 1 Duravelo-1 data for zelenectide pevedotin in metastatic urothelial cancer. Combination with pembrolizumab showed response rates comparable to published standard-of-care data, with low rates of severe treatment-related toxicities.
The optimal 6mg/m2 dose achieved a 65% overall response rate in first-line mUC and 37% in pretreated patients, with no Grade 4–5 zelenectide-related adverse events of clinical interest. Further randomized Phase 2 data are expected in 2H 2026.
Bicycle Therapeutics (NASDAQ: BCYC) reported Q1 2026 results and program updates. Cash and cash equivalents were $559.5 million as of March 31, 2026, with an expected cash runway into 2030. The company highlighted clinical and imaging data for EphA2-targeting programs nuzefatide pevedotin and a Bicycle Imaging Agent, and presented Duravelo-2 dose selection data with a 58–65% ORR range.
Strategic reprioritization includes converting Duravelo-2 to a randomized Phase 2, closing two Duravelo trials, a ~30% workforce reduction and ~50% estimated annual operating expense reduction.
Bicycle Therapeutics (NASDAQ: BCYC) will present one oral and four poster abstracts at the ASCO 2026 Annual Meeting in Chicago, May 29–June 2, 2026. Presentations focus on interim and updated data for zelenectide pevedotin (BT8009) in locally advanced/metastatic urothelial carcinoma.
The rapid oral session is scheduled for June 1, 8:30–8:36 a.m. CT (Abstract 4516). Multiple posters will be shown on May 31, 9 a.m.–12 p.m. CT (Abstracts 4563, 4564, 4566, 4567). Materials will be posted on the company website the morning of each session.
Bicycle Therapeutics (NASDAQ: BCYC) reported AACR 2026 updates on its EphA2 portfolio, highlighting clinical and preclinical progress for nuzefatide pevedotin and EphA2 imaging agents. Key points: 40% confirmed ORR in EphA2+ metastatic urothelial cancer (mUC) cohort and 100% ORR in MMAE-naïve EphA2+ mUC (3/3).
Preclinical PDAC PDX studies showed EphA2 expression in 16/16 models and sensitivity in 10/14 models. Company identified 8mg/m2 Q2W as preferred monotherapy dose and dosed the first patient in a 2L+ PDAC Phase 2 trial in April 2026. EphA2 imaging demonstrated rapid tumor uptake and metastasis detection in human PET/CT data.
Bicycle Therapeutics (NASDAQ: BCYC) will present one oral and four poster abstracts at the AACR Annual Meeting 2026 in San Diego, April 17-22, 2026. Presentations include preclinical and early clinical data on BT5528 and an EphA2-targeting PET imaging bicyclic peptide.
Oral presentation on BT5528 in HNSCC is scheduled for April 19, 4:05-4:20 p.m. PT; posters span April 19-21. Materials will be posted in the company Publications section at the start of poster sessions.
Bicycle Therapeutics (NASDAQ: BCYC) reported Q4 and full-year 2025 results and strategic reprioritization. Key clinical update: Duravelo-2 dose selection identified 6mg/m2 (two weeks on, one week off) as optimal for zelenectide with physician-assessed ORR 65% and BICR-confirmed ORR 58% (27-week cutoff; later adjusted to 62% with an additional confirmed response).
Company will convert Duravelo-2 to a randomized Phase 2 and deprioritize internal development of zelenectide. Cash was $628.1M at year-end, with planned cuts extending runway into 2030. Multiple isotope and supply partnerships were established to support a radiopharmaceutical pipeline.
Bicycle Therapeutics (NASDAQ: BCYC) announced leadership transitions to support its oncology pipeline. Travis Thompson becomes chief financial officer, succeeding Alethia Young who will remain interim CFO for three months and then advise. Michael Method is promoted to chief medical officer, and Michael Skynner moves from CTO to chief scientific officer.
The company said it expects strengthened operational capacity and a financial runway into 2028, will progress targeted oncology clinical programs, and plans to advance new radiopharmaceutical strategic partnerships.
Bicycle Therapeutics (NASDAQ: BCYC) reviewed 2025 progress and set 2026 priorities focused on klinical development and radiopharmaceutical supply capabilities. Key near-term items include dose selection and a potential approval pathway for zelenectide pevedotin from the Phase 2/3 Duravelo-2 trial and regulatory feedback expected in 1Q 2026. The company plans multiple clinical data readouts across 2026: Duravelo-2 dose data and Duravelo-1 follow-ups in H1 2026, Duravelo-3 initial data in H2 2026, and BT5528/BT7480 combination updates in H1 2026. Bicycle also reported first human imaging for EphA2 and MT1-MMP BRC molecules and describes emerging supply collaborations for 212Pb alongside existing 177Lu and 68Ga supply chains. The company expects financial runway into 2028 to support these priorities.
Bicycle Therapeutics (NASDAQ: BCYC) announced a 15-year contract with the UK Nuclear Decommissioning Authority for access to up to 400 tonnes of reprocessed uranium (RepU), plus an option to renew, intended to support a sustainable source of 212Pb for radiopharmaceutical development.
The company also disclosed partnerships with the United Kingdom National Nuclear Laboratory to scale 228Th extraction and with SpectronRx to develop a bespoke 212Pb generator; initial quantities of 212Pb have been produced. Bicycle said these arrangements aim to enable an end-to-end supply chain for its Bicycle Radioconjugates (BRC) portfolio and noted plans to present initial EphA2 human imaging data in H1 2026 and to initiate a company-led Bicycle study in 2026.
Bicycle Therapeutics (NASDAQ: BCYC) announced that management will participate in a fireside chat at the Jefferies London Healthcare Conference on Tuesday, Nov. 18, 2025 at 10:30 a.m. GMT.
A live webcast will be accessible from the company's Investor section at www.bicycletherapeutics.com, with an archived replay available after the event.