CytoDyn expects to hear a completion date from regulators next month for its leronlimab license application

CytoDyn Inc (OTCQB:CYDY) announced Monday that the US Food and Drug Administration (FDA) has set July 10 as the potential date for when the company can expect news about when the biologics license application (BLA) review of its potential coronavirus (COVID-19) drug leronlimab will be completed. On July 10, the company could be issued what’s called a PDUFA (Prescription Drug User Fee Act) date, which represents the agency’s goal date for completing an application.  The FDA typically takes 10 months to review a BLA, the company said, but CytoDyn has filed for a Priority Review designation, which could cut that time to six months. READ: CytoDyn asks regulator to review its application to license leronlimab for HIV treatment under priority designation CytoDyn is currently enrolling coronavirus patients in two clinical trials of leronlimab - a Phase 2 trial for patients with mild-to-moderate symptoms and a Phase 2bb/3 trial for severe and critically ill patients. “We are very encouraged by our recent correspondence with the FDA and remain hopeful of a PDUFA date to be announced by the agency on July 10,” CytoDyn CEO Nader Pourhassan said in a statement. “The review of our BLA could not be more timely, as our other trials for COVID-19 are approaching two important milestones and should the outcome be successful, we believe the information in this BLA could be very useful in expediting approval of leronlimab to treat COVID-19, as well as HIV.” Leronlimab was previously granted Fast Track designation by the agency for its indications as a treatment for metastatic triple-negative breast cancer and as part a combination therapy for HIV-infected patients. It’s BLA, in this case, was granted a rolling review, the company said. The drug works by blocking CCR5, a cellular receptor that is important in HIV infection, tumor metastases and other diseases. Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel