CytoDyn

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  CytoDyn Announces Productive Pre-BLA Meeting with FDA for PRO 140 Combination Therapy

  1:28 PM | June 22, 2018

  Rolling BLA Submission Starting as Early as the End of 2018  – FDA Provides Guidance on Ongoing Requirements VANCOUVER, Washington, June 22, 2018 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company developing new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that it had a productive meeting with the U.S. Food and Drug Administration (FDA) regarding the Company’s planned Biologics License Application (BLA).  Based on FDA feedback, the Company will continue to gather safety and efficacy data

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  Results from CytoDyn’s Pivotal PRO 140 Combination Therapy Trial in HIV to be Presented at ASM Microbe 2018 on June 9

  5:01 PM | June 4, 2018

  VANCOUVER, Washington, June 04, 2018 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB:CYDY) announced today that results from a Phase 2b/3 trial with PRO 140 (humanized CCR5 monoclonal antibody) in heavily treatment-experienced HIV-1 patients will be presented in a Late-Breaker Abstract poster session at ASM Microbe on Saturday, June 9, in Atlanta.  The trial results detail data from the one-week, single-dose, randomized, double-blind, placebo-controlled portion of the pivotal trial of PRO140 in combination with optimized background anti-retroviral therapy (ART). Session 226: Late

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  CytoDyn Receives Orphan Drug Designation for PRO 140 for Prevention of Graft Versus Host Disease

  1:55 PM | October 5, 2017

  VANCOUVER, Washington, Oct. 05, 2017, CYDY, (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PRO 140 for the prevention of graft versus host disease (GvHD).  Orphan drug designation is granted to development-stage drugs that have shown promise in addressing serious medical needs for patients living with rare conditions.  This designation provides

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  CytoDyn Provides Update on PRO 140 Pivotal Combination Therapy Trial in Patients with HIV

  1:15 PM | August 21, 2017

  VANCOUVER, Washington, Aug. 21, 2017, CYDY, (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that the Company has enrolled 34 patients in its pivotal Phase 2b/3 trial of PRO 140 in combination with antiretroviral therapy (ART) in HIV-infected patients. Thirty-three of the enrolled patients have finished the one-week efficacy endpoint of the study and eleven patients have completed the full 25-week protocol with undetectable viral

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  CytoDyn Treats First Patient with PRO 140 in Phase 2 Trial for Graft versus Host Disease

  9:00 AM | May 17, 2017

  VANCOUVER, Washington, May 17, 2017, CYDY, (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, announces the treatment of the first patient in its Phase 2 clinical trial for Graft versus Host Disease (GvHD), its leading immunologic indication for PRO 140. GvHD is a potentially life-threatening complication in patients requiring a bone marrow transplant because their immune systems have been depleted during aggressive cancer therapy for

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  CytoDyn Files for Breakthrough Therapy Designation With the FDA for PRO 140 in HIV Therapy

  9:40 AM | January 11, 2017

  VANCOUVER, Washington, Jan. 11, 2017, CYDY, (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced the Company filed a request for Breakthrough Therapy Designation with the FDA for PRO 140 as a treatment for HIV-1 infection in treatment-experienced patients with virologic failure. While the standard of care for HIV infection has been a combination of medications from different antiretroviral classes that interfere with different

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