CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients
CYTODYN INC (CYDY)
NASDAQ:AMEX Investor Relations:
ir.cytodyn.com
Company Research
Source: GlobeNewswire
During the FDA’s review period, the Company will dedicate all resources to ensure availability of leronlimab for COVID-19 patients; Cancer programs continue with positive results VANCOUVER, Washington, April 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, today announced the Company has submitted the clinical, and the CMC (chemistry, manufacturing and controls) portions of its BLA to the U.S. Food and Drug Administration (FDA) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients. The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Company’s BLA in HIV indication. “The submission of the final two parts of the BLA is a significant milestone for the Company, and initiates its transition from a development-stage compa
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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
- 11/22/24 - Form 8-K
- 10/30/24 - Form 4
- 10/30/24 - Form 4
- CYDY's page on the SEC website