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 Inc. (CYDY) reported significant findings from its CD12 trial of leronlimab for COVID-19 patients. Analysis showed an 82% reduction in mortality at 14 days when leronlimab was added to standard care (p=0.0233), with treated patients 5 times more likely to survive. The 7-point ordinal scale ranking improved by 400% (p=0.021). Previous analyses indicated benefits in combination with common treatments, with a 6.5% absolute reduction in mortality at day 28 and a 5.5-day reduction in hospital stay. CytoDyn aims to expedite regulatory submissions to utilize leronlimab for critically ill patients.
CytoDyn Inc. (OTC.QB: CYDY) announced promising results from a case study and its completed Phase 3 trial of leronlimab for critically ill COVID-19 patients. The study published in the Journal of Translational Autoimmunity shows significant recovery rates, with five out of six ECMO patients improving post-treatment. The FDA has granted Fast Track designation for leronlimab in two indications: HIV and triple-negative breast cancer. CytoDyn aims to refile its Biologics License Application in 2021, focusing on the therapeutic potential of leronlimab in various conditions.
CytoDyn Inc. (CYDY) announced the Philippines FDA granted a Compassionate Special Permit for its COVID-19 treatment, leronlimab. This approval allows shipping leronlimab to Chiral Pharma Corporation in the Philippines. The company aims to seek Emergency Use Authorization (EUA) for broader access and is exploring treatment for COVID-19 long-hauler patients. Leronlimab is currently being developed for various indications, including HIV and metastatic triple-negative breast cancer, and has shown promise in clinical trials with significant viral load reduction.
CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast scheduled for March 22, 2021. Management will update stockholders on its recent COVID-19 related filings for Conditional EUA with the FDA, Interim Order in Canada, and accelerated reviews in the U.K., along with plans for similar submissions in Brazil and the Philippines. The update will also cover ongoing clinical trials related to COVID-19, NASH, and cancer, as well as expected timelines for BLA submissions for HIV in the U.S., Canada, and the U.K.
CytoDyn Inc. (OTC.QB: CYDY) announced the appointment of Dr. Christopher P. Recknor as Chief Operating Officer. Dr. Recknor, who previously served as Vice President of Clinical Development, brings extensive experience with over 100 clinical trials. He will collaborate with the senior management team to enhance business strategy and clinical priorities. The FDA has granted Fast Track designation for leronlimab in HIV and metastatic triple-negative breast cancer, supporting its potential in critical therapies.
CytoDyn (OTC.QB: CYDY) announced the enrollment of 20 patients in its Phase 2 trial investigating Vyrologix™ (leronlimab) for COVID-19 long-hauler symptoms. The trial aims to enroll 50 patients, with each receiving eight doses followed by a safety evaluation. Results are anticipated by mid-summer 2021. This study is critical as it seeks to address the lack of treatment options for patients suffering from prolonged COVID-19 symptoms. The company also noted progress in its other trials and a planned Biologics License Application (BLA) submission for HIV.
CytoDyn Inc. (OTC.QB: CYDY) announced the release of CD12 Phase 3 trial data for leronlimab, aimed at treating critically ill COVID-19 patients. Key findings include:
- 24% reduction in all-cause mortality.
- Shortened hospital stays with a significance of p=0.0050.
- Improved discharge alive rates: 28% vs. 11%.
Statistically significant results were noted in age-adjusted analyses. The company is set to pursue further studies with regulatory consultations from the FDA and other agencies.
CytoDyn Inc. (CYDY) announced the submission of a protocol to the U.S. FDA for enrolling 140 critical COVID-19 patients in a trial. This follows the enrollment of 46 additional patients in the open-label portion of the CD12 trial. The company is also engaging with Health Canada for potential sales of leronlimab in Canada. Recent data indicate a statistically significant reduction in mortality among patients receiving leronlimab compared to placebo. CytoDyn plans to refile its Biologics License Application for HIV treatment in the first half of 2021.
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.
FAQ
What is the current stock price of Cytodyn (CYDY)?
What is the market cap of Cytodyn (CYDY)?
