FDA Grants Rolling Review for CytoDyn’s Planned
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Posted On: 03/04/2019 6:03:30 AM
FDA Grants Rolling Review for CytoDyn’s Planned BLA for Investigational HIV Therapy Leronlimab (PRO 140)
https://www.cytodyn.com/media/press-releases/...ed-bla-for
FIRST PORTION OUT OF THREE PORTIONS OF BLA TO BE FILED IN MARCH
VANCOUVER, Washington, March 04, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the FDA has reviewed and accepted CytoDyn’s request and plan to submit on a rolling basis its planned Biologics License Application (BLA). Leronlimab (PRO 140) is a humanized IgG4 mAb that is subcutaneously injected to block HIV-1 from entering and infecting immune cells.
“We are extremely proud of the effort of our entire team to reach this very important milestone,” stated Dr. Nader Pourhassan, President, CEO and Director of CytoDyn. “We are grateful to the FDA for its timely and professional review and acceptance of our request for a rolling review of our planned BLA for PRO 140. As previously announced, we expect to complete the first section (of three) of the BLA for PRO 140 with submission to the FDA in March 2019.”
https://www.cytodyn.com/media/press-releases/...ed-bla-for
FIRST PORTION OUT OF THREE PORTIONS OF BLA TO BE FILED IN MARCH
VANCOUVER, Washington, March 04, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the FDA has reviewed and accepted CytoDyn’s request and plan to submit on a rolling basis its planned Biologics License Application (BLA). Leronlimab (PRO 140) is a humanized IgG4 mAb that is subcutaneously injected to block HIV-1 from entering and infecting immune cells.
“We are extremely proud of the effort of our entire team to reach this very important milestone,” stated Dr. Nader Pourhassan, President, CEO and Director of CytoDyn. “We are grateful to the FDA for its timely and professional review and acceptance of our request for a rolling review of our planned BLA for PRO 140. As previously announced, we expect to complete the first section (of three) of the BLA for PRO 140 with submission to the FDA in March 2019.”
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