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. has reported significant progress in their oncology programs as of March 2025. The company announced increased survival rates in patients with metastatic Triple-Negative Breast Cancer (mTNBC) treated with leronlimab, with some patients now cancer-free. Their Phase II colorectal cancer study is advancing with eight approved clinical sites.
Key developments include:
- Submission of findings to the European Society for Medical Oncology meeting in Munich (May 2025)
- Initiation of follow-up protocols for surviving mTNBC patients
- Advancement in preclinical studies for TNBC treatment optimization
- Progress in glioblastoma multiforme (GBM) research
In inflammation studies, CytoDyn is awaiting NIH/RECOVER-TLC decision for Long Covid treatment studies and has finalized a pilot study protocol for Alzheimer's Disease at Cornell Medical Center. Recent laboratory results showed statistically significant reversal of liver fibrosis (p< 0.01) in all three SMC Laboratories studies. The company reports having sufficient cash and drug supply to advance clinical priorities in 2025.
CytoDyn (OTCQB: CYDY) announced encouraging survival outcomes for metastatic triple-negative breast cancer (mTNBC) patients treated with leronlimab, their CCR5 antagonist drug candidate. The company reported favorable survival rates at 12, 24, and 36 months compared to current therapies, with some patients who previously failed treatment now showing no evidence of disease.
Following resolution of a dispute with their former CRO, CytoDyn obtained follow-up records and submitted findings to the upcoming ESMO Breast Cancer meeting in Munich. The company has initiated two pre-clinical studies to evaluate potential synergies between leronlimab and other treatments (sacituzumab govitecan and pembrolizumab).
The drug was reported to be well-tolerated with minimal treatment-related adverse events. The company plans to accelerate its oncology efforts, with future announcements expected in both mTNBC and colorectal cancer treatments.
CytoDyn (OTCQB: CYDY) has announced significant results from three preclinical studies conducted with SMC Laboratories, demonstrating that leronlimab, their CCR5 antagonist drug, achieved statistically significant reversal of liver fibrosis in monotherapy (p-values < 0.01 vs control). Two studies completed in late 2024 evaluated leronlimab in the STAM™ model of metabolic dysfunction associated steatohepatitis (MASH) with fibrosis, while a third study concluded in January 2025 assessed liver fibrosis reversal using carbon tetrachloride.
Dr. Melissa Palmer, the Company's Lead Consultant in Hepatology, emphasized the significant unmet need in hepatology for managing advanced liver fibrosis. The company is exploring partnership opportunities to advance leronlimab's clinical development for treating fibrosis in the liver and potentially other organs, while maintaining focus on its 2025 oncology objectives.
CytoDyn (CYDY) provided a comprehensive year-end update highlighting several key developments. The company has secured sufficient cash and drug supplies for its 2025 clinical priorities and is making progress on developing a long-acting formulation of leronlimab. Recent additions to the development team include Dr. Melissa Palmer (Lead Consultant in Hepatology), Dr. Max Lataillade (SVP and Head of Clinical Development), and Dr. Richard Pestell (Lead Consultant in Oncology).
The company is prioritizing oncology in 2025, having received FDA clearance to initiate a Phase II study in colorectal cancer. Additional focus areas include triple-negative breast cancer (TNBC) and glioblastoma (GBM). In inflammation, promising results were reported from preclinical MASH studies, with ongoing research in Long Covid and Alzheimer's disease. The company is also partnering with amfAR for an HIV cure study called LATCH.
CytoDyn has appointed Richard Pestell, M.D., Ph.D. as Lead Consultant in Preclinical and Clinical Oncology. Dr. Pestell, who previously served as Vice Chairman and CMO, will lead the company's R&D strategy in oncology for leronlimab development. He brings over 30 years of research experience and currently serves as President of the Pennsylvania Cancer and Regenerative Medicine Research Center. During his previous tenure at CytoDyn, he was instrumental in obtaining FDA Fast Track Designation for leronlimab in combination with carboplatin for CCR5-positive metastatic triple-negative breast cancer treatment. Dr. Pestell's work includes over 600 publications with more than 95,000 citations.
CytoDyn (OTCQB: CYDY) has received FDA clearance to begin its Phase II oncology trial evaluating leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (CRC). The clearance follows productive feedback sessions with the FDA and submission of the final study protocol in September 2024. The trial will be conducted in partnership with Syneos Health, with a kickoff meeting scheduled for late November 2024 and patient enrollment beginning in early 2025. The company's CCR5 antagonist, leronlimab, shows potential for multiple therapeutic indications.
CytoDyn (OTCQB: CYDY) has appointed Dr. Melissa Palmer as Lead Consultant in Hepatology to drive the company's research and development strategy for liver conditions. Following promising initial results, CytoDyn has commissioned two follow-up studies with SMC Laboratories to confirm fibrosis reversal observations, with results expected in early 2025. The studies will compare leronlimab alone and in combination with other therapies, including resmetirom and a GLP-1 agonist. Dr. Palmer, an internationally renowned hepatologist with over three decades of experience and previous interim CMO role at CytoDyn, will oversee these studies focusing on MASH and liver fibrosis treatments.
CytoDyn Inc. (OTCQB: CYDY) has appointed Dr. Max Lataillade as Senior Vice President and Head of Clinical Development. Dr. Lataillade, with over 20 years of research experience, will lead the company's global R&D strategy and oversee end-to-end R&D activities. He previously served as Vice President at ViiV Healthcare and Bristol-Myers Squibb, specializing in HIV research. Dr. Lataillade is also an assistant clinical professor at Yale University School of Medicine.
CytoDyn's CEO, Dr. Jacob Lalezari, expressed enthusiasm about the appointment, citing Dr. Lataillade's industry accomplishments and skillset as valuable assets for progressing the company's development pipeline. Dr. Lataillade aims to leverage his experience to pursue strategic development opportunities and advance CytoDyn's clinical pipeline, particularly focusing on the development of leronlimab, a CCR5 antagonist with potential for multiple therapeutic indications.
CytoDyn Inc. (OTCQB: CYDY) announced the acceptance of an abstract for presentation at the 5th annual HIV Research for Prevention Conference. The abstract highlights research on combining early antiretroviral therapy (ART) with broadly neutralizing antibodies (bNAbs) and leronlimab, a CCR5 antagonist, in infant rhesus macaques infected with Simian Human Immunodeficiency Virus (SHIV).
Key findings include:
- The study aimed to assess if this combination could provide sustained viral control without continuous ART
- 18 infant rhesus macaques were treated with various combinations of ART, bNAbs, and leronlimab
- No virus rebound was observed in treated animals over a 27-week period
- Results suggest potential for durable viral control and reduced need for ongoing ART
The study, funded by an NIH grant to OHSU, will be presented by Dr. Jonah B. Sacha at the conference in Lima, Peru on October 10, 2024.
CytoDyn Inc. (OTCQB: CYDY) has engaged Syneos Health as the contract research organization (CRO) for its upcoming Phase II oncology trial. The trial will evaluate the efficacy of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (CRC). Syneos Health is a leading biopharmaceutical solutions organization with advanced data analytics and AI/ML capabilities.
Dr. Jacob Lalezari, CEO of CytoDyn, stated that investigating leronlimab in oncology remains their top priority. The company expects to generate clinical data affirming the utility of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab. CytoDyn submitted the final study protocol to the FDA for approval in September 2024 and anticipates starting patient screening in early 2025.