BCYC - Bicycle Therapeutics adds 10% on FDA's fast track tag for bladder cancer therapy
- Clinical-stage biotech Bicycle Therapeutics ( NASDAQ: BCYC ) jumped ~10% pre-market Wednesday after announcing that the FDA granted Fast Track Designation for its experimental bladder cancer therapy BT8009.
- Specifically, the FDA has issued the Fast Track Designation for BT8009 as a monotherapy for adults with previously-treated locally advanced or metastatic urothelial cancer.
- The announcement comes as Bicycle Therapeutics ( BCYC ) remains on track to report Phase I dose escalation data for BT8009 at a medical meeting in the first half of 2023.
- The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to communicate frequently with the regulator on plans for clinical studies.
- If certain criteria are met, such programs will also be able to win Accelerated Approval and Priority Review, enabling patients to access those treatments sooner.
- BT8009 is designed to target Nectin-4, a protein commonly found in solid tumors, including urothelial cancer.
- In 2022, Bicycle Therapeutics ( BCYC ) announced the publication of peer-reviewed pre-clinical data on BT8009 in medical journals.
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Bicycle Therapeutics adds 10% on FDA’s fast track tag for bladder cancer therapy