CYDY - CytoDyn files for expanded access use of leronlimab for HIV patients

CytoDyn (OTCQB:CYDY) has filed a request with the FDA for approval of expanded access use of leronlimab for multi-drug resistance HIV patients. The Company has also previously sought FDA approval for CytoDyn to charge for leronlimab used in this patient population and is preparing to file the last portion of this request. “Our Phase 3 pivotal trial, which yielded a statistically significant primary endpoint for efficacy (p=0.0032), had an 81% success rate in suppressing viral load (VL<50 cp/mL) in the MDR population after 24 weeks of leronlimab treatment. This compares to other recent antibody products approved for this population with around 45% suppressed viral load," commented Nader Pourhassan, Ph.D., President and CEO.

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CytoDyn files for expanded access use of leronlimab for HIV patients