BCTX - BriaCell gains on FDA fast track nod for its targeted breast cancer immunotherapy Bria-IMT

Shares of BriaCell Therapeutics (NASDAQ:BCTX) have added ~7% in premarket trading on Wednesday after the U.S. Food and Drug Administration (FDA) granted a Fast Track status to the clinical-stage biotech company’s lead candidate, Bria-IMT, for the treatment of metastatic breast cancer. The FDA's Fast Track approval is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. BriaCell will now be eligible for more frequent meetings with the FDA to discuss Bria-IMT's development plan and more frequent written communication from the FDA about the clinical trial's design, among other things. BriaCell is currently enrolling and dosing advanced breast cancer patients in a phase 1/2a study. BCTX stock recorded its worst intraday decline in more than a year on Tuesday and closed -15.2% at $9.91.

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BriaCell gains on FDA fast track nod for its targeted breast cancer immunotherapy Bria-IMT