BMY - Ikena gains on FDA's fast track status for bladder cancer candidate

2023-03-06 08:42:34 ET

• Ikena Oncology ( NASDAQ: IKNA ) added ~9% pre-market Monday after the cancer-focused pharma company announced the FDA’s Fast Track designation for IK-175, a candidate targeted at urothelial carcinoma.
• Specifically, the FDA has issued Fast Track designation for IK-175 alongside immune checkpoint inhibitors to treat patients with advanced urothelial carcinoma whose cancer progressed within three months from the last checkpoint inhibitor dose.
• 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.
• Citing early-stage data, Ikena ( IKNA ) said in November that IK-175, along with Bristol Myers’ ( BMY ) nivolumab, indicated a 20% overall response rate and 40% disease control rate in heavily pretreated urothelial carcinoma.

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