Welcome to our dedicated page for Cytodyn news (Ticker: CYDY), a resource for investors and traders seeking the latest updates and insights on Cytodyn stock.
CytoDyn Inc. (CYDY) is a clinical-stage biotechnology and oncology company whose news flow centers on the development of leronlimab, a humanized monoclonal antibody targeting the CCR5 receptor. Company announcements frequently highlight progress in solid tumor oncology, particularly metastatic triple-negative breast cancer (mTNBC) and metastatic colorectal cancer (mCRC), as well as broader CCR5-related research.
Investors following CYDY news can expect updates on clinical trial milestones, including Phase 2 studies in mCRC and planned Phase 2 proof-of-concept and combination trials in mTNBC. Press releases and shareholder letters describe retrospective survival analyses, PD-L1 upregulation findings, and the company’s “prime and pair” strategy that combines leronlimab with immune checkpoint inhibitors. Conference-related news often covers poster and oral presentations at major oncology meetings such as the San Antonio Breast Cancer Symposium, European Society for Medical Oncology events, and AACR specialty conferences.
CytoDyn’s news stream also includes corporate and regulatory developments. Recent items have addressed the resolution of government investigations, an agreement in principle to settle a securities class action lawsuit, and stockholder approval of amendments to increase authorized common shares. Financing updates, such as the Standby Equity Purchase Agreement with Yorkville, provide insight into how the company plans to support its clinical programs.
In addition, CytoDyn issues periodic letters to shareholders that summarize operational rebuilding, regulatory interactions, and collaborations with academic centers in areas like glioblastoma, Alzheimer’s disease, and HIV cure research. For readers tracking CYDY, this news page offers a consolidated view of scientific data releases, trial progress, financing arrangements, and governance actions that shape the company’s development trajectory.
CytoDyn Inc. (OTC.QB: CYDY) has announced plans by its Brazilian distribution partner, Biomm S.A., to submit an authorization request to the Brazilian National Health Surveillance Agency (ANVISA) for two Phase 3 clinical trials of leronlimab in treating COVID-19. The trials will target severe and critically ill patients with a total of 900 participants across 45 sites. CytoDyn aims to utilize leronlimab to potentially benefit thousands of COVID-19 patients in Brazil, while also preparing to explore similar partnerships in other countries facing COVID-19 surges.
CytoDyn Inc. (OTC.QB: CYDY) has promoted Antonio Migliarese to Chief Financial Officer, transitioning from Vice President, Corporate Controller. This change follows Michael Mulholland's shift to Senior Vice President of Finance for personal reasons. Migliarese, a CPA with extensive financial experience, will lead CytoDyn's financial organization as it evolves from a pre-revenue biotechnology company to a commercial entity. CytoDyn continues to develop its lead product, Vyrologix™ (leronlimab-PRO 140), with FDA Fast Track designation for HIV and metastatic cancer treatments.
CytoDyn Inc. (OTC.QB: CYDY) announced positive topline results from its CD12 Phase 3 clinical trial focusing on leronlimab for critically ill COVID-19 patients. The study demonstrated significant improvements in mortality rates, showing a 78% reduction with the first dose and 82% with the second. Secondary endpoints were met with statistically significant p-values. Despite not achieving the primary endpoint in the mITT population, CytoDyn aims to submit these findings to regulatory agencies for potential approval in countries like India and the Philippines.
CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast scheduled for May 18, 2021, led by CEO Nader Pourhassan and other executives. The presentation will address ongoing communications with the FDA regarding trial design, focusing on the CD12 trial results for the COVID-19 treatment, leronlimab. The trial did not meet primary endpoint criteria; however, secondary endpoints in a critically ill sub-population showed promise. Investors are encouraged to submit questions before and during the webcast.
CytoDyn Inc. (OTC.QB: CYDY) has signed an exclusive agreement with Macleods Pharmaceuticals Ltd. to distribute leronlimab in India, targeting COVID-19 patients. This partnership aims to address the lack of approved treatments for critically ill COVID-19 patients in India. The agreement was finalized swiftly, and both companies are optimistic about leronlimab's potential to save lives. CytoDyn has also completed a pivotal Phase 3 trial for leronlimab in HIV treatment and plans to resubmit its Biologics License Application by Q3 2021.
CytoDyn Inc. (OTC.QB: CYDY) has announced that its drug candidate, leronlimab, will be featured in a one-hour segment on OneNews in the Philippines on May 9, 2021. Leronlimab has been provided to critically ill COVID-19 patients under Compassionate Special Permits from the Philippine FDA. The segment will include key executives from CytoDyn and medical professionals discussing the drug's potential benefits. Leronlimab has successfully met primary endpoints in clinical trials for HIV and is in the process of resubmitting its Biologics License Application.
CytoDyn Inc. (OTC.QB: CYDY) has partnered with Albert Einstein Israelite Hospital in São Paulo, Brazil, to conduct two Phase 3 COVID-19 trials aimed at seeking regulatory approval from ANVISA for leronlimab. These trials will enroll about 1,500 patients across 45 sites, with an interim analysis planned when 120 critically ill patients are enrolled. The Brazilian COVID-19 crisis intensifies with ICU capacity nearing full. CytoDyn believes these trials may facilitate Emergency Use Authorization (EUA) for leronlimab globally. The company plans to update shareholders on trial progress shortly.
CytoDyn Inc. (OTC.QB: CYDY) announced on May 3, 2021, an upcoming webcast scheduled for May 5, 2021, featuring CEO Nader Pourhassan, CMO Scott Kelly, and COO Chris Recknor. The session aims to provide stockholders with updates on the company's priorities, particularly its COVID-19 initiatives and ongoing trials related to COVID-19, NASH, and cancer. Investors can submit questions online for discussion during the one-hour session, which will be accessible through the company's corporate website.
CytoDyn Inc. (OTC.QB: CYDY) has announced plans for a pre-Breakthrough Therapy designation meeting to expedite preparations for a Phase 3 clinical trial involving leronlimab for 22 solid tumor cancer indications. Encouraging results from preliminary trials suggest potential for a reduced trial size. The company is optimistic about leronlimab's ability to control cancer metastasis and its role in immunotherapy. Additionally, CytoDyn is preparing to resubmit its Biologics License Application (BLA) for HIV treatment, following previous setbacks.
CytoDyn Inc. (OTC.QB: CYDY) announced progress on its HIV treatment, leronlimab, following positive results from three ongoing clinical trials. Approximately 120 patients remain in treatment extensions, with no significant safety issues reported over 4-7 years in 66 open-label patients. The company is on track to submit a Biologics License Application (BLA) for HIV therapy by July 2021, aiming to expedite additional indications, including cancer and COVID-19. Leronlimab has shown promise in controlling HIV viral load, indicating a potential breakthrough in treatment options.