CytoDyn
1111 Main Street
Suite 660
Vancouver
Washington
98660
United States
Website: http://www.cytodyn.com/
308 articles about CytoDyn
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CytoDyn Files for Expanded Access Use of Leronlimab for Multi-Drug Resistance HIV Patients
12/9/2021
CytoDyn will request FDA permission to charge HIV MDR patients under expanded access.
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CytoDyn Submits Protocol with the FDA for Phase 3 Registrational Trial of Leronlimab for Critically Ill COVID-19 Population
12/9/2021
CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), today announced that it has submitted a Phase 3, randomized, double blind, placebo controlled trial with the U.S. Food and Drug Administration (“FDA”) to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for invasive mechanical ventilation ("IMV”) or Extracorporeal Membrane Oxygenation (“ECMO”).
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CytoDyn’s CRO in Brazil Met with ANVISA to Modify CD16 Trial for Critically Ill COVID-19 Patients to Expedite Interim Analysis After 51 Patients, Potentially in 1Q2022
12/8/2021
CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), today announced that its CRO in Brazil (Academic Research Organization (ARO) Albert Einstein Israelite Hospital (AEIH)) met with the Brazilian Health Regulatory Agency (ANVISA) and received its agreement to modify the CD16 trial for critically ill COVID-19 patients.
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CytoDyn Submits CMC (Manufacturing) Section of HIV BLA to FDA Under Previously Authorized Rolling Review; Last (Clinical) Section Will Complete Full BLA Submission
12/1/2021
CytoDyn Inc. today announced it has completed submission of all the major sections of CMC modules to FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week.
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CytoDyn’s Chairman, CMO, and Head of Business Development Dr. Scott A. Kelly to Present at World Antiviral Congress 2021 Beginning Tomorrow
11/29/2021
CytoDyn Inc., a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reminded investors that Dr. Scott Kelly, CytoDyn’s Chairman of the Board, Chief Medical Officer and Head of Business Development, will present at the World Antiviral Congress being held tomorrow, November 30, 2021 through Thursday, December 2, 2021.
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Leronlimab (350 mg) Weekly Use for 14 Weeks in Open Label Arm of NASH Trial Produces Fibrosis Reduction as High as 93 msec Amongst First 15 Patients with Average Reduction of 24 msec
11/24/2021
CytoDyn Inc. today reported data from its trial treating NASH (nonalcoholic steatohepatitis) open label with leronlimab.
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CytoDyn Announces Preliminary Results from 2021 Annual Meeting
11/24/2021
CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced the preliminary vote results from the 2021 Annual Meeting of Stockholders (the “Annual Meeting”), which was held today.
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CytoDyn Research Paper on Leronlimab Published in Frontiers in Immunology Journal
11/19/2021
CytoDyn Inc. today announced that its research paper entitled “CCR5 receptor occupancy analysis reveals increased peripheral blood CCR5+CD4+ T cells following treatment with the anti-CCR5 antibody Leronlimab” has been accepted by Frontiers in Immunology.
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Health Canada Authorizes Emergency Use of Leronlimab for Treatment of First Triple-Negative Breast Cancer Patient in Canada
11/16/2021
CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that Health Canada authorized the emergency use of leronlimab for the treatment of a patient with metastatic triple-negative breast cancer (mTNBC).
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CytoDyn Submits the First of Three Main Sections of HIV BLA to FDA Under Previously Authorized Rolling Review
11/16/2021
CytoDyn Inc., a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced it has initiated the resubmission of its Biologics License Application for HIV under rolling review consistent with guidance from the U.S. Food and Drug Administration.
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CytoDyn Reminds Stockholders to Register 24 hours before November 24th Annual Meeting
11/16/2021
CytoDyn Inc., a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, urged stockholders to register 24 hours prior to the meeting time in order to participate in this meeting.
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CytoDyn Submits Breakthrough Therapy Designation Application to FDA for Leronlimab as a Treatment for Metastatic Triple-Negative Breast Cancer (mTNBC); Fast Track Designation for mTNBC was received previously
11/8/2021
CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has submitted to the U.S. Food and Drug Administration (“FDA”) an application for Breakthrough Therapy designation (“BTD”) for leronlimab as a potential treatment for mTNBC.
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Clinical Catch-Up: November 1-5
11/8/2021
The first week of November was marked by numerous clinical trial announcements. Here’s a look. -
CytoDyn Reports Preliminary Results from First Five Patients in Phase 2 NASH Open Label Leronlimab Trial. Lower Fatty Deposits in All 5 Patients by as Much as 45% and Lower Fibrosis in 4 Patients by as Much as 10% Compared to Baseline.
11/3/2021
CytoDyn Inc., a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced preliminary results from the first five patients treated with leronlimab in its Phase 2 trial for NASH open label.
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CytoDyn Announces Cancer Update: 12-month Analysis of 28 mTNBC Patients Receiving Leronlimab Suggests an Increase of 3600% in 12-month OS in 75% of Patients with a Lower Level of Circulating Cells After Leronlimab Induction or at Baseline;
11/3/2021
CytoDyn Inc., a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced updated results from its current cancer study using leronlimab to treat 28 patients with CCR5+ Metastatic Triple-Negative Breast Cancer, who had failed at least two lines of previous therapy.
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Clinical Catch-Up: October 25-29
11/1/2021
Yet another busy week for clinical trial news. Here’s a look. -
CytoDyn Inc. Announces Adjournment of Annual Meeting of Shareholders to November 24, 2021 Due to Lack of Quorum
10/28/2021
CytoDyn Inc. today convened and then adjourned the 2021 Annual Meeting of Shareholders (the “Annual Meeting”) without transacting any other business. The Annual Meeting was adjourned to be held virtually on Wednesday, November 24, 2021 at 8:00 a.m. Pacific Time.
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CytoDyn Announces FDA Accepts Revised Rolling Review Timeline for Resubmission of its BLA
10/28/2021
CytoDyn Inc. announced the U.S. Food and Drug Administration has accepted the Company’s revised “Rolling Review” timeline for the Company’s upcoming resubmission of its Biologics License Application for leronlimab as a combination therapy for highly treatment experienced HIV patients.
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CytoDyn Announces Treatment of First Patient in Pivotal Phase 3 Trial for Critically Ill COVID-19 Patients in Brazil
10/25/2021
CytoDyn Inc., a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced the treatment of the first patient in its pivotal Phase 3 trial in Brazil for critically ill COVID-19 patients.
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CytoDyn to Hold Webcast and Live Q/A on October 26
10/21/2021
CytoDyn Inc. announced Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, Nitya Ray, Ph.D., Chief Operating Officer and Chief Technology Officer and Christopher Recknor, M.D., Senior Executive VP of Clinical Operations of CytoDyn will host an investment community webcast on Tuesday, October 26, 2021.