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 company advancing leronlimab, an investigational CCR5-targeting therapy with applications in oncology, inflammation, and infectious diseases. This dedicated news hub provides investors and researchers with essential updates on clinical developments, regulatory milestones, and strategic partnerships.
Our curated collection features official press releases and verified news covering clinical trial results, FDA communications, and research collaborations. Users gain access to critical updates about leronlimab's development across multiple therapeutic areas, including ongoing studies in metastatic cancers and inflammatory conditions.
The resource emphasizes CytoDyn's progress in resolving historical challenges and establishing robust clinical protocols. Key content categories include trial design updates, partner announcements with organizations like Syneos Health, and regulatory pathway developments. All materials maintain strict adherence to factual reporting standards.
For those monitoring biopharmaceutical innovation, this page serves as a reliable source for tracking CytoDyn's evidence-based approach to drug development. Bookmark this hub to stay informed about new developments in CCR5-targeted therapies and the company's evolving clinical pipeline.
CytoDyn (OTCQB: CYDY) has announced promising survival data for leronlimab in treating metastatic colorectal cancer (mCRC). The clinical findings showed that 3 out of 5 patients treated with leronlimab achieved at least a partial response, with one patient achieving complete response and surviving for five years.
Dr. Benjamin Weinberg from Georgetown University will present these results at the ESMO Gastrointestinal Cancers Congress 2025 in Barcelona. The data comes from patients treated under a compassionate use protocol and demonstrates both a favorable safety profile and potential clinical benefits. The company is currently conducting a Phase II trial in patients with relapsed/refractory microsatellite stable CRC, with the first patient already dosed.
Additionally, CytoDyn reported evidence of leronlimab's potential as a "priming" agent for cancer patients with low PD-L1 levels who were previously unresponsive to checkpoint inhibitors, showing particular promise in metastatic triple-negative breast cancer (mTNBC) treatment.
CytoDyn (OTCQB: CYDY) has initiated dosing in its Phase II clinical trial evaluating leronlimab for relapsed/refractory microsatellite stable colorectal cancer (CRC). The trial, conducted in partnership with Syneos Health across eight clinical sites, is led by Dr. Ben Weinberg from Georgetown University. According to WHO data, colorectal cancer represents the third most common cancer globally, with approximately 1.9 million new cases and 900,000 deaths annually.
The study builds on CytoDyn's previous research showing potential clinical benefits of leronlimab in relapsed CRC patients and aims to evaluate its mechanism of action in solid tumor oncology. The company's strategy is influenced by promising survival rates observed in prior metastatic triple-negative breast cancer studies.
CytoDyn (OTCQB: CYDY) has revealed promising new data about leronlimab's mechanism of action in treating solid tumors. The company's analysis of metastatic Triple-Negative Breast Cancer (mTNBC) trials showed that 88% (15/17) of patients receiving weekly doses of 525mg or higher experienced significant increases in PD-L1 expression on circulating tumor cells within 30-90 days.
Notably, 100% (5/5) of patients who showed increased PD-L1 expression and received immune checkpoint inhibitors (ICIs) treatment are still alive, with 80% (4/5) showing no evidence of disease. This suggests leronlimab can potentially convert "cold" tumors to "hot" tumors, making them responsive to checkpoint inhibitor therapy. The company believes this mechanism could benefit various solid tumor types, particularly in patients with low PD-L1 levels who were previously unresponsive to checkpoint inhibitors.
CytoDyn is now prioritizing prospective confirmation of these findings in TNBC patients and has amended its colorectal cancer trial to collect PD-L1 data.CytoDyn (OTCQB: CYDY) has appointed Robert E. Hoffman as its new Chief Financial Officer, effective May 15, 2025. Hoffman, a seasoned biotech veteran, will replace interim CFO Mitch Cohen. With extensive experience in financial leadership, Hoffman previously served as President, CEO, interim CFO, and Chairperson at Kintara Therapeutics, and held CFO positions at companies including Heron Therapeutics, Innovus Pharmaceuticals, and AnaptysBio.
Hoffman currently serves on the boards of several companies, including Esperion Therapeutics, TuHURA Biosciences, and Fibrobiologics. His appointment aims to support CytoDyn's clinical development pipeline, particularly in oncology indications. The company is developing leronlimab, a CCR5 antagonist with potential for multiple therapeutic applications.
CytoDyn announces its participation in the upcoming ESMO Breast Cancer meeting in Munich, Germany, scheduled for May 14-17, 2025. The company will present promising survival data for its drug leronlimab in treating metastatic triple-negative breast cancer (mTNBC).
Key highlights:
- CEO Dr. Jacob Lalezari and Lead Consultant Dr. Richard Pestell will lead the presentation
- Poster presentation scheduled for May 15, 2025
- Notable survival rates observed at 12, 24, and 36 months
- Four patients show no evidence of disease after 48 months
- One additional patient maintains stable disease
The company reports these outcomes compare favorably to current approved therapies and suggests a potential paradigm shift in solid tumor oncology treatment. CytoDyn has initiated a follow-up protocol to monitor surviving patients.
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.
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