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 (OTCQB: CYDY) announced that an anonymous benefactor committed funding to support an Expanded Access Program (EAP) for patients with triple‑negative breast cancer (TNBC) to receive leronlimab. The company engaged WEP Clinical as CRO and expects to open the program for patient referral in March 2026, subject to FDA allowance of a revised protocol submission. The EAP is intended for patients who have exhausted approved treatments and do not meet ongoing trial criteria, and the company says the program may provide opportunities to observe PD‑L1 induction after leronlimab with potential combination pathways with immune checkpoint inhibitors. Additional physician and patient information will be posted on the company website as the program rolls out.
CytoDyn (OTC:CYDY) closed 2025 reporting retrospective survival observations linking leronlimab treatment, subsequent PD-L1 expression on circulating tumor cells, and follow-up immune checkpoint inhibitor (ICI) therapy.
Five patients treated this way remain alive at five years; three show no evidence of disease. The company says leronlimab may convert PD-L1–negative tumors into PD-L1–positive (“cold” to “hot”) tumors by blocking CCR5, enabling a “prime and pair” ICI strategy. Ongoing Phase 2 colorectal cancer trial is active and a Phase 2 mTNBC trial is planned for 2026. Management highlights operational strengthening, regulatory engagement, and financial discipline.
CytoDyn (OTCQB: CYDY) announced a poster presentation at the San Antonio Breast Cancer Symposium showing cleronlimab (leronlimab) treatment associated with PD-L1 upregulation on circulating tumor cells and cancer-associated macrophage-like cells in metastatic triple-negative breast cancer (mTNBC).
Key reported outcomes from a pooled retrospective analysis of 28 women: median overall survival 7.1 months (95% CI: 4.8–17.7), survival at years 1–4 of 35.7%, 21.4%, 17.9%, 17.9%; 100% (5/5) of patients with PD-L1 induction >400 RFU who then received an ICI remain alive after median 60.9 months; PD-L1 upregulation seen in 76% (16/21) overall and 88% (15/17) at 525/700 mg; higher doses showed longer survival (HR 3.44; P=0.0418) and ICI-treated patients had longer survival (HR 4.14; P=0.0041).
CytoDyn (OTCQB: CYDY) announced it reached an agreement in principle to resolve the securities class action filed in March 2021, with the parties agreeing to a settlement on November 23, 2025. The matter remains pending final court approval in the United States District Court for the Western District of Washington and additional details are included in the company’s Form 8-K filed with the SEC on December 1, 2025.
Management said the settlement provides clarity for stockholders and partners and allows the company to focus on advancing Phase II studies in metastatic colorectal cancer and metastatic triple-negative breast cancer and progress in its Expanded Access Program.
CytoDyn (OTCQB: CYDY) announced a poster presentation at the San Antonio Breast Cancer Symposium (SABCS) on December 12, 2025 reporting prolonged survival and sustained remission in some patients with metastatic or locally advanced triple-negative breast cancer after treatment involving leronlimab and PD-L1/PD-1 immune checkpoint inhibitors.
The poster, presented by Dr. Milana V. Dolezal (Stanford), links leronlimab-associated PD-L1 upregulation on cancer-associated macrophage-like cells and circulating tumor cells with improved outcomes, noting 3 individuals with no current evidence of disease. The poster ID is PS5-02-30 and will be available on the company website after SABCS.
CytoDyn (OTCQB: CYDY) announced a $30 million funding commitment from Yorkville Advisors Global dated November 3, 2025.
Under the agreement CytoDyn may sell, at its discretion, up to $30 million of common stock to Yorkville over the next 36 months; Yorkville is obligated to purchase amounts the company elects to sell. The company controls timing of all sales, there are no warrants, derivatives, or other share classes tied to the arrangement, and there are no minimum use requirements or operating restrictions. CytoDyn said it intends to use the commitment to further develop leronlimab programs, including research on upregulating PD-L1. Additional terms are disclosed in CytoDyn’s Form 8-K filed November 3, 2025.
CytoDyn (OTCQB: CYDY) announced that CFO Robert E. Hoffman will present a corporate overview at the LD Micro Main Event XIX investor conference in San Diego from October 19–21, 2025.
The presentation is scheduled for Tuesday, October 21, 2025 at 9 a.m. PDT and will be available via webcast. Topics noted include the company’s development strategy for leronlimab, a CCR5‑targeting monoclonal antibody with programs in triple‑negative breast cancer and metastatic colorectal cancer. Mr. Hoffman is available for one‑on‑one investor meetings; meeting requests go to CytoDyn@russopartnersllc.com.
CytoDyn (CYDY) released a shareholder letter highlighting significant progress in advancing leronlimab for oncology treatment. The company announced promising survival data in Metastatic Triple-Negative Breast Cancer (mTNBC), with survival rates of 35.7%, 21.4%, 17.9%, and 17.9% at years 1-4 respectively.
Key developments include the appointment of Robert E. Hoffman as CFO, closure of SEC and DOJ investigations, and advancement in clinical trials. The company revealed a novel mechanism of action for leronlimab that induces PD-L1 expression, creating potential synergy with immune checkpoint inhibitors. A Phase II proof of concept protocol for PD-L1-negative mTNBC patients is planned, alongside an Expanded Access Protocol for second-line mTNBC treatment.
The company is also progressing in metastatic Colorectal Cancer trials with five sites initiated and more being onboarded.
CytoDyn (OTCQB: CYDY) will present significant findings on leronlimab's effectiveness in treating metastatic triple-negative breast cancer (mTNBC) at the AACR Special Conference in Montreal. The company's retrospective analysis of 28 patients revealed that leronlimab, when administered at doses >525mg/week, induced PD-L1 expression in 88% of patients.
Key clinical findings showed that 5 out of 5 patients who received both leronlimab and immune checkpoint inhibitors (ICIs) remain alive after approximately 60 months of treatment. The study demonstrated that 18% of heavily pretreated mTNBC patients survived after a median of ~60 months when treated with CCR5 inhibition combined with ICI therapy.
The research suggests leronlimab could potentially enhance the effectiveness of checkpoint inhibitors in treating solid tumors, particularly in cases previously resistant to such treatments.
CytoDyn (OTCQB: CYDY), a clinical-stage oncology company, will present research findings on its lead drug leronlimab at the AACR Special Conference on Cancer Immunity from September 24-27, 2025, in Montreal. The company's Lead Consultant, Dr. Richard Pestell, will deliver both poster and oral presentations focusing on leronlimab's effects on metastatic triple-negative breast cancer (TNBC).
The research suggests that leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, may convert 'cold' tumors to 'hot' tumors, potentially enhancing responsiveness to checkpoint inhibitors. This mechanism could have broad implications for treating solid tumors with limited treatment options.
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