Montreal, Canada-based Telesta Therapeutics (TSX: TST) has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for MCNA.
MCNA (Mycobacterium phlei cell wall-nucleic acid complex) is a biologic therapy derived from the cell wall fractionation of Mycobacterium phlei. MCNA is Telesta's novel biologic immunotherapeutic for the treatment of high-risk non-muscle invasive bladder cancer patients who have failed first-line BCG therapy.
BLA application fee waiver
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