Bicycle Therapeutics PLC BCYC
Bicycle Therapeutics PLC (Nasdaq: BCYC) is an oncology drug developer. Its lead program, Zelenectide pevedotin (Nectin-4 BDC), is in Phase 2 for Metastatic urothelial cancer. Its next catalyst on record is BT7480: Report certain Phase I/II data in 2026, after which internal development ends and partnering is explored (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: BT7480 — Report certain Phase I/II data in 2026, after which internal development ends and partnering is explored (2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Zelenectide pevedotin (Nectin-4 BDC) | Metastatic urothelial cancer (Duravelo-2, converted to randomized Phase II; deprioritized) | protein/peptide | Phase 2 |
| Nuzefatide pevedotin (EphA2 BDC, BT5528) | Recurrent metastatic pancreatic ductal adenocarcinoma (Phase II); advanced solid tumors (Phase I/II) | protein/peptide | Phase 2 |
| BT7480 (Nectin-4/CD137 Bicycle TICA) | Advanced malignancies | protein/peptide | Phase 1 |
| Zelenectide pevedotin Phase I/II (NECTIN4-amplified breast and NSCLC) | Breast cancer, NSCLC | protein/peptide | Phase 1 |
| BT1702 (MT1-MMP radioconjugate, 212Pb) | Solid tumors | radiopharmaceutical | Pre-clinical |
| Bicycle Imaging Agents (BIA) | Oncology imaging | radiopharmaceutical | Pre-clinical |
Recent results and decisions
- May 21, 2026positive Optimal-dose combination showed 65% (17/26) ORR and 58% (15/26) BICR-confirmed ORR at week 27, with low skin reaction (17%) and neuropathy (33%) rates; median PFS immature.
65% (17/26) overall response rate (ORR) regardless of confirmation and blinded independent central review (BICR) confirmed ORR of 58% (15/26) at the 27-week cutoff.
Filing - Mar 17, 2026positive Duravelo-2 dose selection identified 6mg/m2 as optimal with physician-assessed ORR 65% and BICR-confirmed ORR 58% at 27 weeks, comparable to standard of care.
Initial dose selection data from the Duravelo-2 trial demonstrate response rates comparable to those published for existing standards of care, with physician assessed overall response rate (ORR) of 65%, blinded independent central review (BICR) confirmed ORR of 58% at the 27-week cutoff and a differ
Filing - Mar 17, 2026n/a Regulators deemed the existing Duravelo-2 design unacceptable as an approval path; trial being converted to randomized Phase 2 and program deprioritized for internal development.
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.
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
- Tango Therapeutics, Inc. TNGX
- Tyra Biosciences, Inc. TYRA
- Verastem, Inc. VSTM
- Obsidian Therapeutics, Inc. OBX
- Puma Biotechnology, Inc. PBYI
- Fulgent Genetics, Inc. FLGT
- Delcath Systems, Inc. DCTH
- Unknown Unknown
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.