$CYDY
CytoDyn (OTCQB: CYDY) Provides Update on BLA Submission for HIV Therapy
CytoDyn (OTCQB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced 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.
Why it Matters: 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.
Key Quote: “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.” – Nader Pourhassan, Ph.D., President and CEO
Backstory: CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.
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