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CytoDyn Inc. reports developments for leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor. The company is a clinical-stage oncology issuer focused on CCR5 biology in difficult-to-treat cancers, including metastatic triple-negative breast cancer and metastatic colorectal cancer.
Recurring news includes clinical and translational data presentations, Phase 2 colorectal cancer study updates, expanded access activity for triple-negative breast cancer, and preclinical work in glioblastoma. Company updates also cover financing actions used to support leronlimab development and corporate webcasts addressing scientific, operational, clinical, and financial progress.
CytoDyn (OTCQB: CYDY), a clinical-stage oncology company advancing leronlimab, announced that CFO Robert E. Hoffman will present a corporate overview at the LD Micro Invitational XVI in Los Angeles.
The presentation is scheduled for May 18, 2026 at 10 a.m. PDT and will be available via webcast.
CytoDyn (OTCQB: CYDY) announced dosing of the first patient in an Expanded Access Program (EAP) for leronlimab in triple-negative breast cancer on April 27, 2026. The EAP provides access for patients who exhausted options, will follow FDA guidelines, and aims to collect real-world biological insights including PD-L1 associations reported at AACR 2026.
The company engaged WEP Clinical to support patient ID, site coordination, and regulatory compliance; physician referrals are now open.
CytoDyn (OTCQB: CYDY) will host an investor webcast on April 30, 2026 at 1:00 p.m. PT to provide a corporate and clinical update on leronlimab.
Presenters include CEO Dr. Jacob P. Lalezari, Dr. Pashtoon M. Kasi, and CFO Robert E. Hoffman. A live Q&A will follow and a replay will be available for ~30 days.
CytoDyn (OTCQB: CYDY) presented new Phase 2 data at AACR 2026 showing early clinical and biomarker activity for leronlimab combined with TAS-102 and bevacizumab in previously treated metastatic colorectal cancer (mCRC).
Key findings: CCR5 expression in 100% of pre-screened cases (N=33), median ctDNA declines ~70% by week 2 (evaluable N=19), no leronlimab-related DLTs, and dose escalation to 700 mg underway.
CytoDyn (OTCQB: CYDY) completed enrollment in its Phase 2 CLOVER study of leronlimab plus TAS-102 and bevacizumab in CCR5-positive, MSS relapsed/refractory metastatic colorectal cancer on April 21, 2026.
Just over 60 patients were enrolled across seven U.S. sites; the company plans treatment, follow-up, and topline data reporting to inform next development steps.
CytoDyn (OTCQB: CYDY) presented translational and clinical data at AACR 2026 showing that leronlimab (CCR5 inhibitor) induces PD-L1, modulates immune checkpoints, and associates with prolonged survival in metastatic triple-negative breast cancer (mTNBC).
In a retrospective cohort (N=28), PD-L1 induction in CTCs/CAMLs and higher dose or ICI combination correlated with better outcomes; 17.9% (5/28) remain alive beyond 60 months. Poster #1033 was presented April 19, 2026.
CytoDyn (OTCQB: CYDY) will present two posters at the American Association for Cancer Research Annual Meeting 2026, April 17–22 in San Diego. The presentations report preclinical and preliminary clinical data on leronlimab in metastatic triple-negative breast cancer and metastatic colorectal cancer.
Poster 1033 (April 19) examines PD-L1 induction and ICI survival in PD-L1 low mTNBC; Poster 6466 (April 21) presents preliminary phase 2 results of leronlimab with TAS-102 and bevacizumab in previously treated mCRC. Presentations will be posted under Publications & Posters after the meeting.
CytoDyn (OTCQB: CYDY) presented preclinical and translational data at the AACR Special Conference on Brain Cancer (March 23-25, 2026) showing leronlimab-mediated CCR5 inhibition enhances temozolomide and radiation responses in glioblastoma.
Findings: CCR5 is elevated in GBM tumor cores, associates with hypoxia/glycolysis and T-cell exhaustion, and leronlimab showed functional synergy with standard therapies; a pilot clinical study is planned. Poster #A002 presented March 23, 2026.
CytoDyn (OTCQB: CYDY) closed a $17.5 million financing on March 5, 2026 to fund further development of leronlimab, its CCR5-targeting humanized monoclonal antibody being evaluated in oncology indications including TNBC and mCRC.
Net proceeds will primarily support ongoing and planned clinical trials, regulatory engagement, data analysis, manufacturing readiness, compliance infrastructure, and general working capital, and are expected to fund operations into 2027.
CytoDyn (OTCQB: CYDY) presented preclinical, translational, and clinical data on leronlimab at AACR IO (Feb 18-21, 2026) exploring CCR5 blockade in metastatic triple-negative breast cancer (mTNBC).
Key points: mechanistic signals show increased PD-L1 and modulation of T-cell exhaustion; a pooled retrospective cohort (n=28) reported favorable safety and 5 of 28 patients alive after median follow-up >63 months.