CytoDyn Files FDA-Suggested Modifications to IND and Protocol for Phase 2 Clinical Trial for COVID-19 Patients with Mild to Moderate Indications and a Second Randomized Protocol for All CO...
CYTODYN INC (CYDY)
NASDAQ:AMEX Investor Relations:
ir.cytodyn.com
Company Research
Source: GlobeNewswire
VANCOUVER, Washington, March 27, 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 that, at the suggestion of the U.S. Food and Drug Administration (FDA), the Company filed another round of modifications to its IND and protocol for a Phase 2 clinical trial with leronlimab (PRO 140). In addition, the FDA suggested the Company file a second randomized protocol for all COVID-19 patients in severe condition, so as to preclude each physician from filing an emergency IND for every patient to be treated with leronlimab. The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response w
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CYDY
News
- CytoDyn Phase 2 study of leronlimab cleared by FDA [Seeking Alpha]Seeking Alpha
- CytoDyn Announces FDA Clearance of Its Phase II Oncology TrialGlobeNewswire
- CytoDyn Appoints Dr. Melissa Palmer, M.D., as Lead Consultant in Hepatology; Announces Follow-Up Inflammation Studies with SMC LaboratoriesGlobeNewswire
- CytoDyn Appoints Dr. Max Lataillade as Senior Vice President and Head of Clinical Development [Yahoo! Finance]Yahoo! Finance
- CytoDyn Appoints Dr. Max Lataillade as Senior Vice President and Head of Clinical DevelopmentGlobeNewswire
CYDY
Sec Filings
- 10/30/24 - Form 4
- 10/30/24 - Form 4
- 10/30/24 - Form 4
- CYDY's page on the SEC website