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) announced positive results from its Phase 3 trial of leronlimab for severely ill COVID-19 patients. The trial showed a 24% decrease in all-cause mortality, a 6-day reduction in hospital stays, and a 166% higher chance of being discharged alive at Day 28 compared to placebo. The company is in discussions with the FDA, MHRA, and Health Canada for potential approval. There are ongoing efforts to enroll more patients while preparing a manuscript for publication.
CytoDyn Inc. (OTC.QB: CYDY) has submitted a protocol to the U.S. FDA for the immediate enrollment of 140 critical COVID-19 patients, aiming to support a potential Emergency Use Authorization (EUA) for leronlimab. The FDA is reviewing this submission while the Company explores regulatory pathways in the U.K. and Canada. Preliminary data indicates leronlimab may significantly impact mortality rates among elderly patients. With a Fast Track designation, CytoDyn is focusing on enhancing accessibility of leronlimab for COVID-19 treatment amidst ongoing trials and regulatory discussions.
CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast on March 8, 2021, to discuss data from its Phase 3 trial for severe-to-critically ill COVID-19 patients. Management, including CEO Nader Pourhassan and CMO Scott Kelly, will outline the regulatory path forward across multiple countries and provide updates on clinical and corporate priorities. The webcast will allow for 90 minutes of Q&A, accessible via CytoDyn's website.
CytoDyn Inc. (OTC.QB: CYDY) announced positive results from its Phase 3 trial of leronlimab for treating critically ill COVID-19 patients. The study showed a 24% reduction in mortality and a 6-day shorter hospital stay compared to placebo. Additionally, the probability of being 'discharged alive' at Day 28 was 28% for leronlimab patients against 11% for the placebo group. The Company is in discussions with regulatory agencies to expedite approval. These outcomes highlight leronlimab’s potential as a safe and effective treatment for this vulnerable patient group.
CytoDyn Inc. (OTC.QB: CYDY) announced a new “universal shelf” registration statement on Form S-3 with the SEC, replacing the previous registration expiring on March 7, 2021. This allows CytoDyn to maintain registration of unexercised warrants and provides flexibility for future capital access. No immediate plans to offer securities exist, and no sales can occur until the registration becomes effective. The shelf registration has been active since 2016, enabling timely capital market access.
CytoDyn Inc. (OTC.QB: CYDY) has unblinded the data from its CD12 clinical trial for COVID-19 and expects to conclude discussions with regulatory agencies within 2 to 3 weeks. The trial involved 394 patients and evaluated the efficacy of Vyrologix™ (leronlimab-PRO 140). The FDA has granted leronlimab Fast Track designation for treatment of critical illnesses, including a combination therapy for HIV and metastatic triple-negative breast cancer. The company anticipates refiling its Biologics License Application in the first half of 2021.
CytoDyn (OTC.QB: CYDY) announced its collaboration with Chiral Pharma Corp. to provide 200,000 vials (100,000 doses) of leronlimab for potential sales in the Philippines, specifically targeting COVID-19 patients. The company seeks a Compassionate Special Permit (CSP) for registration, aiming to conduct trials and gather data from Philippine patients receiving the treatment. CytoDyn's Phase 2 clinical trial for COVID-19 showed significant results, with expectations to release more data soon. The FDA has granted Fast Track designation for leronlimab for critical medical conditions.
CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast on October 20, 2020, at 2:00 pm PT to discuss the Data Safety Monitoring Committee's recommendations following an interim analysis of 195 patients in its Phase 2b/3 clinical trial for severe-to-critical COVID-19. The webcast will feature a presentation and a Q&A session. The event is accessible via the company's website and will be archived for 30 days after the event.
CytoDyn Inc. (OTC.QB: CYDY) announced an upcoming investment community webcast on October 20, 2020, to discuss recommendations from the Data Safety Monitoring Committee (DSMC) based on an interim analysis of the Phase 2b/3 trial for severe-to-critical COVID-19. Key management, including President Nader Pourhassan, will provide insights into a potential regulatory path forward. The webcast will feature a presentation followed by a Q&A session. Access will be through CytoDyn's corporate website, with replay available for 30 days.
CytoDyn (OTC.QB: CYDY) announced the appointment of Chiral Pharma Corporation to register leronlimab (PRO 140) for potential COVID-19 treatment approval in the Philippines. The company is conducting Phase 2 and Phase 3 trials for COVID-19, with interim results expected mid-October. Leronlimab has received Fast Track designation for indications in HIV and metastatic triple-negative breast cancer. The drug has shown promising results in multiple clinical trials, significantly reducing HIV viral load and tumor metastasis.
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