CYDY - CytoDyn submits leronlimab Breakthrough Therapy designation application to the FDA

CytoDyn (OTCQB:CYDY) has submitted to the U.S. FDA an application for Breakthrough Therapy designation for leronlimab as a potential treatment for Metastatic Triple-Negative Breast Cancer ((mTNBC)). Previously, the FDA had granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The company had posted preliminary results from the first five patients treated with leronlimab in its Phase 2 trial for NASH (nonalcoholic steatohepatitis) open label, earlier this month.

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CytoDyn submits leronlimab Breakthrough Therapy designation application to the FDA