CytoDyn Inc.

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CytoDyn, Inc. is a clinical-stage biotechnology company, which focuses on the clinical development of innovative treatments for multiple therapeutic indications based on its product candidate, leronlimab, a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5. Its pipeline includes Leronlimab Clinical Development Pipeline and Long-Acting CCR5 Inhibitor Development Pipeline. The company was founded by Allen D. Allen on May 2, 2002 and is headquartered in Vancouver, WA.

CytoDyn Inc. (OTCQB:CYDY), a late-stage biotechnology company developing its flagship drug leronlimab for multiple indications, revealed that it has initiated the resubmission of its Biologics License Application (BLA) for HIV (human immunodeficiency virus) under rolling review consistent with guidance from the US Food and Drug Administration (FDA). In a statement, CytoDyn CEO Nader Pourhassan said: “We are pleased to begin the HIV BLA resubmission process with continued guidance from the FDA.

CytoDyn submits the first of three main sections of its HIV Biologics License Application to FDA under rolling review

Second portion out of three major portions of BLA (CMC portion) will be submitted shortly

CytoDyn Submits the First of Three Main Sections of HIV BLA to FDA Under Previously Authorized Rolling Review

CytoDyn Inc revealed that it has submitted to the US Food and Drug Administration (FDA) an application for Breakthrough Therapy designation (BTD) for its flagship drug leronlimab as a potential treatment for Metastatic Triple-Negative Breast Cancer (mTNBC).  The Vancouver, Washington-based late-stage biotechnology company said the application is based on the data analysis reported by the company on November 3, 2021.

CytoDyn submits Breakthrough Therapy designation application to FDA for leronlimab as a treatment for Metastatic Triple-Negative Breast Cancer

Ongoing analysis of data from 28 mTNBC patients following 12 months of treatment with leronlimab is very encouraging given little-to- no effective treatment options currently

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

CytoDyn recently reported preliminary analysis from Leronlimab in mTNBC patients and NASH. I believe this data supports further development of Leronlimab in NASH and cancer indications. The recent data has provided me enough confidence to change my strategy. I am looking to start allocating some of my shares for a long-term position at these levels.

CytoDyn: Recent Data Warrants A Change In Game Plan

CytoDyn Inc. has revealed strong updated results from its current cancer study on leronlimab, a monoclonal antibody investigational drug the company is developing, suggesting a sharp rise in survival rates.

CytoDyn reveals ‘very strong' updated results for cancer patients receiving its flagship drug leronlimab

VANCOUVER, Washington, Nov. 03, 2021 (GLOBE NEWSWIRE) -- 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 updated results from its current cancer study using leronlimab (in varying doses) to treat 28 patients with CCR5+ Metastatic Triple-Negative Breast Cancer (“mTNBC”), who had failed at least two lines of previous therapy. This ongoing updated analysis is from 28 pooled patients, 16 from our Compassionate Use Study, 10 from the Phase 1b/2 Study, and 2 from the Basket Study.

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; 12-month PFS Co

VANCOUVER, Washington, Nov. 03, 2021 (GLOBE NEWSWIRE) -- 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 preliminary results from the first five patients treated with leronlimab in its Phase 2 trial for NASH (nonalcoholic steatohepatitis) open label. These preliminary findings from five patients treated with leronlimab suggested fatty deposits were lowered on all 5 patients by as much as 45%, as compared to the baseline measurement. In addition, fibrosis was also lowered by as much as 10%, in 4 out of 5 patients as compared to the baseline measurement (one patient exhibited no change in fibrosis).

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.

VANCOUVER, Wash.--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, 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. The adjournment provides the Company

CytoDyn Inc. Announces Adjournment of Annual Meeting of Shareholders to November 24, 2021 Due to Lack of Quorum

CytoDyn Inc said that the US Food and Drug Administration (FDA) has accepted its revised “rolling review” timeline for the upcoming resubmission of its biologics license application (BLA) for leronlimab as a combination therapy for highly treatment-experienced HIV patients.  A rolling review enables a drug company to submit completed sections of its BLA for review by the FDA, rather than waiting until every section of the BLA is complete before the entire application is reviewed.

CytoDyn says US FDA accepts revised rolling review timeline for resubmission of its biologics license application

Management expects the non-clinical and CMC sections of the BLA to be resubmitted to FDA in November

CytoDyn Announces FDA Accepts Revised Rolling Review Timeline for Resubmission of its BLA

CytoDyn Inc has announced treatment of the first patient in its pivotal Phase 3 trial CD16 in Brazil for critically ill Coronavirus (COVID-19) patients, which it is conducting with Brazil's BIOMM and academic research organisation (ARO). The Vancouver, Washington-based late-stage biotechnology company said an interim analysis will be conducted 28 days following the enrollment of 127 patients.

CytoDyn announces treatment of first patient in pivotal Phase 3 trial for critically ill Coronavirus patients in Brazil

Based on previous strong sub-population analysis in CD12 trial, CytoDyn intends to file for an EUA when interim analysis of 127 patients is completed

CytoDyn Announces Treatment of First Patient in Pivotal Phase 3 Trial for Critically Ill COVID-19 Patients in Brazil

VANCOUVER, Washington, Oct. 21, 2021 (GLOBE NEWSWIRE) -- 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 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 to Hold Webcast and Live Q/A on October 26

VANCOUVER, Wash.--(BUSINESS WIRE)--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 the Delaware Court of Chancery has denied a motion by the activist group led by Paul Rosenbaum and Bruce Patterson (the “Activist Group”) to prevent the Company's 2021 Annual Meeting of Stockholders (the “Annual Meeting”) from taking place as scheduled on Oc

CytoDyn Announces Delaware Court Has Denied Activist Group's Motion to Prevent Annual Meeting from Taking Place

VANCOUVER, Wash.--(BUSINESS WIRE)--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 shareholders will receive proxy material beginning this week from the Company in connection with its upcoming 2021 Annual Meeting of Stockholders on October 28, 2021 (the “Annual Meeting”). The Company urges all shareholders to vote their shares immedia

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

NEW YORK--(BUSINESS WIRE)--A group of long-time stockholders (the “Investor Group”) of CytoDyn Inc. (“CYDY” or the “Company”) that has nominated five highly experienced director candidates to serve on the Company's Board of Directors today commented on the decision made by the Delaware Court of Chancery to deny the Investor Group's request to force the Company to allow stockholders the opportunity to vote for the Investor Group's nominees. The Investor Group stated: “We believe strongly that th

Group of CytoDyn Stockholders Comments on Delaware Court Decision

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VANCOUVER, Wash.--(BUSINESS WIRE)--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 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”). All of the A

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

VANCOUVER, Washington, Oct. 07, 2021 (GLOBE NEWSWIRE) -- 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 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 will present for 30 minutes and 90 minutes will be dedicated to live questions and answers.

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

CytoDyn Inc has announced a study for treating triple-negative breast cancer (TNBC) with its flagship drug leronlimab in a humanized TNBC xenograft model.  The late-stage biotechnology company said the investigator-initiated study is being led by Dr Jangsoon Lee, assistant professor of Breast Medical Oncology Research at The University of Texas MD Anderson Cancer Center.

CytoDyn announces study to evaluate potential synergistic effects of Leronlimab with immune checkpoint blockade

Clinical Trial Development Targeting Triple-Negative Breast Cancer (TNBC) to Evaluate Anti-Tumor Effects and Identify Immunological Biomarkers for Leronlimab in Combination with Immune Checkpoint Blockade

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

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 Names Chris Recknor, M.D. Senior Executive VP of Clinical Operations to Initiate Two New Clinical Trials for Stroke and Alzheimer's, While Nitya Ray, Ph.D.

All clinical activities have been moved away from Amarex; a complete update on all activities will be provided to shareholders next week by Drs. Recknor, Kelly, Ray, and Pourhassan

CytoDyn Announces Legal Actions Against its Former CRO, Amarex Clinical Research

CytoDyn continues to match leronlimab up against COVID-19. The company recently started two clinical trials in Brazil where the pandemic endures. If the Brazilian trials hit their endpoints, CytoDyn could file for EUAs in several countries. I expect these trials to produce better results than the U.S. trials.

News for CytoDyn Inc. Stock (CYDY)