CytoDyn Files Pivotal Trial Protocol for HIV Monotherapy with FDA
CYTODYN INC (CYDY)
NASDAQ:AMEX Investor Relations:
ir.cytodyn.com
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Source: GlobeNewswire
After four years of monotherapy trials, data is now available to submit the long-anticipated pivotal trial for monotherapy to the FDA Trial will include 10 weeks of induction therapy to identify which patients are likely to respond and which patients can safely return to their original HAART regimen VANCOUVER, Washington, May 15, 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, announced today that it has filed with the U.S. Food and Drug Administration (FDA) the pivotal trial protocol for leronlimab as a monotherapy for HIV patients. The latest investigative monotherapy trial for HIV has now produced sufficient data for the Company’s Key Opinion Leaders to design a monotherapy pivotal Phase 3 trial. The objective of this trial is to assess the treatment strategy and clinical safety of using leronlimab subcutaneous (SC) 700mg weekly d
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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