CYDY - CytoDyn receives Canadian approval to file application for leronlimab as combination therapy for HIV
Health Canada has cleared CytoDyn (CYDY) to file its Biologics License Application ((BLA)) for leronlimab as a combination therapy for multi-drug resistance HIV patients in Canada. The BLA filing includes a treatment regimen of one injection per week of 350 mg of leronlimab, as contrasted to the dosage used in the Phase 3 U.S. trial of two consecutive injections of 175 mg per week.Health Canada conducted a two-hour meeting with CytoDyn and provided an update on the progress of the Company’s COVID-19 trials and BLA application for the U.K.Additionally, CYDY announces registration of trademark for Vyrologix in several countries.Vyrologix is the proprietary name for leronlimab. Final approval of the proprietary name is conditional on FDA approval of the BLA and new drug application.Over the past one year, CYDY has rallied more than 725%, currently trading at $2.48.CytoDyn has been under fire over the past few months as short-sellers continue to take aim at the
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CytoDyn receives Canadian approval to file application for leronlimab as combination therapy for HIV