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 has received FDA approval to initiate a Phase 3 clinical trial assessing leronlimab for critically ill COVID-19 patients requiring invasive mechanical ventilation or ECMO. The trial will randomly assign patients to receive up to four IV doses of 700 mg leronlimab or placebo alongside standard care. The company aims to address the urgent need for effective COVID-19 treatments as cases surge in the U.S. Leronlimab has previously shown positive outcomes in early trials, with over 100 eINDs accepted by the FDA.
CytoDyn (OTCQB: CYDY) announced preliminary results from its Phase 2 trial for treating NASH with leronlimab. Over 14 weeks, patients showed an average cT1 reduction of 31.2 msec. Notably, 5 of 6 patients with severe NASH experienced an average cT1 drop of 108 msec and a 20% reduction in fatty deposits. The trial, involving 20 patients, aims to assess the drug's efficacy against liver fibrosis, with broader implications for the urgent need for NASH treatments, as no FDA-approved options currently exist.
CytoDyn Inc. (OTCQB: CYDY) will host an investment community webcast on December 14, 2021, featuring key executives discussing the company's developments, particularly on leronlimab, a CCR5 antagonist. The 60-minute session includes a 20-minute presentation followed by a 40-minute Q&A segment. CytoDyn is focused on advancing its BLA for HIV therapy and exploring further indications for leronlimab, including potential treatments for COVID-19 long-haulers and various solid tumors. More details can be found on their official site.
CytoDyn has engaged the FDA regarding the development of leronlimab for critically ill COVID-19 patients, finding the project's feasibility promising amid a decline in hospitalizations. The company has submitted a Phase 3 clinical trial to evaluate leronlimab's efficacy combined with standard care for patients needing invasive mechanical ventilation or ECMO. Prior Phase 3 results indicated an 82% survival rate in a subgroup after two doses. The new trial aims for improved outcomes with four doses. CytoDyn remains optimistic about its pipeline across various therapeutic areas.
CytoDyn has requested FDA approval for expanded access to use leronlimab in multi-drug resistant (MDR) HIV patients. This follows a successful Phase 3 trial showing an 81% success rate in suppressing viral load, significantly outperforming existing treatments (45%). Nearly all participants in the trial requested continued treatment. If approved, this will provide crucial access for MDR HIV patients needing alternative therapies. CytoDyn is also preparing to finalize its request to charge for the drug in this context.
CytoDyn Inc. has announced that its Clinical Research Organization (CRO) in Brazil received approval from the Brazilian Health Regulatory Agency (ANVISA) to modify the CD16 trial for critically ill COVID-19 patients. The modification reduces total enrollment from 330 to 126 patients, with an interim analysis after 51 patients complete follow-up. The trial employs four doses of 700 mg of leronlimab via IV infusion. Previous results showed an 82% survival benefit after two doses, and the company aims to leverage this for improved outcomes.
CytoDyn has completed submission of essential CMC modules for its Biologics License Application (BLA) for HIV to the FDA, with only the clinical section pending.
The submission is being processed under a rolling review, reflecting progress after previous challenges. The company is excited about upcoming submissions related to COVID-19 long-haulers and HIV data.
Additional efforts include a request for expanded use of leronlimab for multi-drug resistant HIV patients. CytoDyn aims for a successful operational year in 2022.
CytoDyn Inc. (OTCQB:CYDY) will have Dr. Scott Kelly, the Company’s Chairman and Chief Medical Officer, present at the World Antiviral Congress from November 30 to December 2, 2021. Dr. Kelly's presentation, scheduled for November 30 at 2:55 PM PST, will explore the antiviral potential of leronlimab, a CCR5 antagonist. CytoDyn is focused on developing innovative treatments for conditions such as HIV and various cancers, having completed several clinical trials. The Company aims to resubmit its Biologics License Application (BLA) for HIV combination therapy by early 2022.
CytoDyn Inc. has announced that shareholders have approved all proposals at its 2021 Annual Meeting, including the election of six new directors and the ratification of Warren Averett, LLC as the independent accounting firm for the fiscal year ending May 31, 2022. Additionally, shareholders approved executive compensation and the amendment to increase authorized common stock from 800 million to 1 billion shares. These developments indicate strong shareholder support and strategic governance changes for the company.
CytoDyn Inc. (OTCQB: CYDY) announced positive interim results from its open-label trial of leronlimab for treating NASH (nonalcoholic steatohepatitis). After 14 weeks, patients exhibited up to 45% fat reduction and 8% fibrosis reduction, indicating potential effectiveness for both NASH and NAFLD. The company plans to apply for Fast Track Designation for both conditions and aims for a Phase 3 protocol submission with the FDA following comprehensive results in mid-December.
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