Update on HIV-BLA-PDUFA FDA requested more information to complete a substantive review. No additional trials required. CytoDyn plans to submit the requested information and will ask for a Type A meeting with the FDA per the agency’s suggestion
Update on COVID-19: CytoDyn is planning to lock and unblind the Phase 2 COVID-19 trial data later this week. Periodic safety review by Data Safety Monitoring Committee (DSMC) for ongoing
Phase 3 study (severe/critical population) is planned for next week. Both results to be announced in July
CytoDyn holds investment community call today, Monday, July 13 at 1:00 pm PT
VANCOUVER, Washington, July 13, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has received a Refusal to File letter from the U.S. Food and Drug Administration (“FDA”) regarding its Biologics License Application (“BLA”) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients. CytoDyn is confident it can provide all information requested by the FDA.
CytoDyn previously announced it submitted all remaining parts of its BLA for leronlimab on May 11, 2020. Pursuant to FDA guidelines, CytoDyn informed the FDA it had submitted a complete BLA for rolling review. In its comments on May 13, CytoDyn stated as a next step after receiving the BLA, the FDA would start reviewing the BLA for completeness and would make a filing decision. The FDA has informed the Company its BLA does not contain certain information needed to complete a substantive review and therefore, the FDA will not file the BLA at this time.
CytoDyn intends to request a Type A meeting with the FDA to discuss its request for additional information. The FDA’s request does not require any additional clinical trials to be conducted, rather the Company will conduct additional analysis of completed trials.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented: “We are 100% committed and confident we can provide the necessary information to the FDA as soon as possible. No additional trials will be required and all the information the FDA has requested is obtainable. While we await upcoming results in our two major COVID-19 Phase 2 and Phase 3 trials, we are confident July will be very important month for our shareholders. I understand many of our shareholders are very eager to see these results soon and I welcome the opportunity to answer any questions from our shareholders during today’s conference call held by the Company,” added Dr. Pourhassan.