CytoDyn

263 articles with CytoDyn

• 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.

• 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.

• 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.

• 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).

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• CytoDyn Alerts Shareholders to Vote on Company’s Proxy Card Ahead of October 28th Annual Meeting

  10/18/2021

  CytoDyn Alerts Shareholders to Vote on Company’s Proxy Card Ahead of October 28th Annual Meeting

• Delaware Court Agrees with CytoDyn that Activist Group’s Nominations are Invalid

  10/14/2021

  CytoDyn Inc. today announced that the Delaware Court of Chancery found that CytoDyn’s Board of Directors properly rejected a nomination notice presented by an activist group led by Paul Rosenbaum and Bruce Patterson (the “Rosenbaum/Patterson Group” or the “Activist Group”).

• CytoDyn to Present at Emerging Growth Conference on October 13 Followed by Live Q/A

  10/7/2021

  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 provide a comprehensive business update at the upcoming Emerging Growth Conference.

• CytoDyn Names Chris Recknor, M.D. Senior Executive VP of Clinical Operations to Initiate Two New Clinical Trials for Stroke and Alzheimer’s

  10/7/2021

  New hires in Bioanalytical Sciences, Biostatistics, Clinical Regulatory, and Clinical Project Management will join the team of Drs. Srinivasan, Recknor, Ray, and Kelly to lead all clinical trials with new CROs

• CytoDyn Announces Study to Evaluate Potential Synergistic Effects of Leronlimab with Immune Checkpoint Blockade (ICB)

  10/7/2021

  CytoDyn Inc., a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced a study for treating triple-negative breast cancer with leronlimab in a humanized TNBC xenograft model.