CytoDyn Submits the First of 3 Main Sections of HIV BLA to FDA

 Second portion out of three major portions of BLA (CMC portion) will be submitted shortly

Clinical section (last portion to complete BLA) expected to be submitted during Q1 2022

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it has initiated the resubmission of its Biologics License Application (“BLA”) for HIV under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”).

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are pleased to begin the HIV BLA resubmission process with continued guidance from the FDA. Due to the work of our management and regulatory advisory team, we believe the application’s issues have been successfully addressed, allowing us to advance the process. The resubmission will include non-clinical and CMC sections during November, followed by submission of the clinical section in Q1 of 2022. Meanwhile, we are very excited that patients who participated in the CD02, pivotal, Phase 3 trial, who needed to continue with leronlimab, are now reaching, in some cases, 4 years with suppressed viral load in an extension arm of our CD02 trial. Therefore, CytoDyn will also file for expanded access use of leronlimab for a fee to MDR HIV patients who might need leronlimab urgently, possibly as soon as next week. CytoDyn ultimately selected a new BLA team to replace its prior contract research organization. While a difficult decision, it was in the Company’s best interest due to the revisions needed in many areas of the BLA. We would like to thank our partners who worked over the past year to get us to where we are today. This is an exciting step for CytoDyn, and we look forward to sharing continued positive developments.”

https://baytownsun.com/coronavirus/article_64df03f8-f05a-54ce-acb4-030c06ce583d.html