This section highlights FDA-related milestones and regulatory updates for drugs developed by Bicycle Therapeutics (BCYC).
Over the past two years, Bicycle Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BT5528, BT8009, MT1-MMP, and Zelenectide. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
BT5528 FDA Regulatory Events
BT5528 is a drug developed by Bicycle Therapeutics for the following indication: Advanced Solid Tumors Associated with EphA2 Expression.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BT5528
- Announced Date:
- May 23, 2024
- Indication:
- Advanced Solid Tumors Associated with EphA2 Expression
Announcement
Bicycle Therapeutics plc announced that emerging Phase 1/2 clinical pharmacokinetic (PK) and safety data for Bicycle Toxin Conjugates® (BTC® molecules) BT8009 and BT5528 demonstrating differentiated safety and tolerability profiles will be presented at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting, taking place May 31-June 4 in Chicago.
AI Summary
Bicycle Therapeutics plc announced that emerging Phase 1/2 clinical pharmacokinetic and safety data for its Bicycle Toxin Conjugates® (BTC®) molecules BT8009 and BT5528 will be presented at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting, scheduled for May 31–June 4 in Chicago. The data reveal differentiated safety and tolerability profiles when compared to traditional antibody drug conjugates, underlining the potential of these BTC molecules for enhanced cancer treatment. Notably, BT8009—now identified by its International Nonproprietary Name, zelenectide pevedotin—and BT5528 exhibit unique pharmacokinetics, including rapid clearance from the body and lower rates of treatment-related toxicities such as peripheral neuropathy and skin reactions. This early-stage clinical information supports the continued development of these molecules for patients with advanced cancers, including those with metastatic urothelial cancer.
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BT8009 (Bicycle Toxin Conjugate zelenectide pevedotin ) FDA Regulatory Events
BT8009 (Bicycle Toxin Conjugate zelenectide pevedotin ) is a drug developed by Bicycle Therapeutics for the following indication: Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BT8009 (Bicycle Toxin Conjugate zelenectide pevedotin )
- Announced Date:
- September 14, 2024
- Indication:
- Solid tumors
Announcement
Bicycle Therapeutics plc announced updated Phase 1/2 clinical results for Bicycle Toxin Conjugate (BTC®) zelenectide pevedotin (formerly BT8009) in metastatic urothelial cancer (mUC)
AI Summary
Bicycle Therapeutics plc announced updated Phase 1/2 clinical results for their investigational therapy, Bicycle Toxin Conjugate (BTC®) zelenectide pevedotin, in patients with metastatic urothelial cancer (mUC). The study showed a promising overall response rate of 45% among efficacy-evaluable patients, with one patient achieving a complete response and several others showing partial responses. Additionally, patients who responded to the treatment maintained that response for a median duration of 11.1 months.
The therapy specifically targets the tumor antigen Nectin-4 and has demonstrated a generally well-tolerated safety profile. Notably, treatment-related side effects such as peripheral neuropathy were low in both frequency and severity, allowing most patients to continue with the therapy without needing any modifications. These encouraging results contribute to Bicycle Therapeutics' promise of developing treatments that enhance both life expectancy and quality of life for cancer patients.
Read Announcement- Drug:
- BT8009 (Bicycle Toxin Conjugate zelenectide pevedotin )
- Announced Date:
- July 22, 2024
- Indication:
- Solid tumors
Announcement
Bicycle Therapeutics plc nnounced the acceptance of four abstracts for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2024, taking place September 13-17 in Barcelona.
AI Summary
Bicycle Therapeutics plc has announced that four abstracts have been accepted for poster presentations at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, which will take place from September 13-17. The abstracts cover important updates and results from their innovative clinical studies, using their proprietary Bicycle® technology.
One study presents updated results of BT8009 monotherapy in patients with metastatic urothelial carcinoma. Additional abstracts explore issues like peripheral neuropathy following treatment with Bicycle Toxin Conjugates and provide early findings from Phase 1/2 studies of BT5528 and BT7480 in patients with advanced solid tumors. These poster sessions all are scheduled for Saturday, September 14, between 9-10 a.m. CEST. The posters will be available on the Bicycle Therapeutics website after the presentations.
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MT1-MMP FDA Regulatory Events
MT1-MMP is a drug developed by Bicycle Therapeutics for the following indication: For cancer treatment and demonstrate the positive properties of Bicycle® Radioconjugates (BRC®) for radiopharmaceutical imaging.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MT1-MMP
- Announced Date:
- April 29, 2025
- Indication:
- For cancer treatment and demonstrate the positive properties of Bicycle® Radioconjugates (BRC®) for radiopharmaceutical imaging.
Announcement
Bicycle Therapeutics plc announced the presentation of additional human imaging data that validate the potential of MT1-MMP, a tumor antigen overexpressed in many cancers, as a novel target for cancer treatment and demonstrate the positive properties of Bicycle® Radioconjugates (BRC®) for radiopharmaceutical imaging.
AI Summary
Bicycle Therapeutics plc has presented new human imaging data that validate the potential of MT1-MMP as a promising target for cancer treatment. This tumor antigen is overexpressed in many cancers, and the imaging studies—performed on 12 patients with various solid tumors—demonstrate that Bicycle® Radioconjugates (BRC®) can effectively visualize cancerous tissues. The data show rapid tracer distribution and significant uptake in both primary tumors and metastases, supporting earlier preclinical research and indicating strong translatability to clinical applications. These encouraging results pave the way for further development of radiopharmaceutical therapies using Bicycle® technology. Future updates are anticipated, including initial human imaging data for a second target, EphA2, later this year, which could further broaden the potential for novel cancer treatment strategies.
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Zelenectide Pevedotin Plus Pembrolizumab FDA Regulatory Events
Zelenectide Pevedotin Plus Pembrolizumab is a drug developed by Bicycle Therapeutics for the following indication: For metastatic urothelial cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Zelenectide Pevedotin Plus Pembrolizumab
- Announced Date:
- February 25, 2025
- Indication:
- For metastatic urothelial cancer
Announcement
Bicycle Therapeutics plc provided recent corporate updates.
AI Summary
Bicycle Therapeutics recently provided corporate updates on its progress in developing next-generation precision-guided therapeutics. The company highlighted updated Phase 1 combination data for zelenectide pevedotin plus pembrolizumab, which showed promising anti-tumor activity and a differentiated safety profile in first-line metastatic urothelial cancer. With encouraging signs in trials, the drug continues to be evaluated in patients, and final dose selection for the Duravelo-2 trial is expected in the second half of 2025.
CEO Kevin Lee emphasized that the positive results support the potential to transform treatment for patients with advanced cancers, including those with NECTIN4 gene-amplified tumors. In addition, Bicycle Therapeutics is advancing its radiopharmaceutical pipeline with early human imaging data and has expanded its clinical advisory board. Strong financial backing is also in place, with $879.5 million in cash ensuring the company’s research and development efforts extend into the second half of 2027.
Read Announcement- Drug:
- Zelenectide Pevedotin Plus Pembrolizumab
- Announced Date:
- January 13, 2025
- Indication:
- For metastatic urothelial cancer
Announcement
Bicycle Therapeutics plc announced updated topline Phase 1 combination data for zelenectide pevedotin plus pembrolizumab in previously untreated (first-line) cisplatin-ineligible patients with metastatic urothelial cancer (mUC). The
AI Summary
Bicycle Therapeutics plc has released updated topline Phase 1 data for a combination of zelenectide pevedotin and pembrolizumab in patients with metastatic urothelial cancer who cannot receive cisplatin. The study focused on previously untreated, first-line patients and showed promising anti-tumor activity. In the trial, 65% of the evaluable patients responded to the treatment, with a 50% confirmed overall response rate. The safety profile of the combination was encouraging, as side effects like peripheral neuropathy, skin reactions, and eye disorders were mostly low grade and manageable. These early results suggest that zelenectide pevedotin, a Bicycle® Toxin Conjugate targeting Nectin-4, may offer a valuable new option for patients with limited treatment choices. The ongoing research aims to further assess the potential benefits and long-term impact of this therapy in metastatic urothelial cancer.
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