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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News
- CytoDyn Announces FDA Has Lifted Clinical Hold [Yahoo! Finance]Yahoo! Finance
- CytoDyn Announces FDA Has Lifted Clinical HoldGlobeNewswire
CYDY
Sec Filings
- 4/16/24 - Form 424B3
- 4/16/24 - Form 424B3
- 4/15/24 - Form 10-Q
- CYDY's page on the SEC website