The FDA rejected CytoDyn’s application for its lead program, an antibody to treat HIV in combination with antiretroviral therapy, because it’s missing some information, the company announced Monday—two months after it revealed it had previously sent the wrong data sets to the agency.
The agency said in a refusal-to-file letter that the Biologics License Application (BLA) for leronlimab “does not contain certain information needed to complete a substantive review,” according to a CytoDyn statement. The Vancouver, Washington-based company did not specify what that information was but expressed confidence that it could produce what the agency wanted.
CytoDyn doesn’t need to carry out more clinical trials to fulfill the FDA’s request, the company said, adding that it would further analyze data from trials it has already finished.
The company’s stock dropped 9% Monday morning on the news before rebounding, but it closed at $3.70, down more than 20% from Friday’s closing price.
CytoDyn says it’s developing leronlimab for various diseases, including breast cancer, graft-versus-host disease, nonalcoholic steatohepatitis and—you guessed it—COVID-19. It announced in April that the BLA for the antibody as a treatment for HIV infection was complete, but backtracked in May, saying it actually had been incomplete until then. The reason? It had included “mock datasets” instead of “clinical datasets.”
In the Monday statement, CytoDyn CEO Nader Pourhassan, Ph.D., pivoted from HIV to COVID-19: “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."
The company is testing the antibody against placebo in a phase 2b/3 study in 390 patients after having provided the drug to 54 patients with severe COVID-19 infection under an Emergency Investigational New Drug application from the FDA. It also has a phase 2 study underway in patients with mild to moderate disease.