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Bicycle Therapeutics (BCYC) FDA Events

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FDA Events for Bicycle Therapeutics (BCYC)

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.

Bicycle Therapeutics' Drugs in FDA Review

BT5528 - FDA Regulatory Timeline and 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.

BT8009 (Bicycle Toxin Conjugate zelenectide pevedotin ) - FDA Regulatory Timeline and 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.

MT1-MMP - FDA Regulatory Timeline and 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.

Zelenectide Pevedotin Plus Pembrolizumab - FDA Regulatory Timeline and 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.

Bicycle Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Bicycle Therapeutics (BCYC) has reported FDA regulatory activity for the following drugs: Zelenectide Pevedotin Plus Pembrolizumab, BT8009 (Bicycle Toxin Conjugate zelenectide pevedotin ), MT1-MMP and BT5528.

The most recent FDA-related event for Bicycle Therapeutics occurred on April 29, 2025, involving MT1-MMP. The update was categorized as "Presentation," with the company reporting: "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."

Current therapies from Bicycle Therapeutics in review with the FDA target conditions such as:

  • For metastatic urothelial cancer - Zelenectide Pevedotin Plus Pembrolizumab
  • Solid tumors - BT8009 (Bicycle Toxin Conjugate zelenectide pevedotin )
  • For cancer treatment and demonstrate the positive properties of Bicycle® Radioconjugates (BRC®) for radiopharmaceutical imaging. - MT1-MMP
  • Advanced Solid Tumors Associated with EphA2 Expression - BT5528

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:BCYC) was last updated on 7/10/2025 by MarketBeat.com Staff
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