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. (OTCQB: CYDY) has released preliminary results from its clinical trial assessing the efficacy of leronlimab for COVID-19 long-haulers. In this trial, 56 patients reported improvements in 18 of 24 COVID-19 symptoms, with no significant safety issues noted. However, the study's small sample size limits statistical validity. The company aims to discuss future regulatory steps with the FDA, seeking Breakthrough Therapy designation for further trials. Leronlimab has previously received FDA Fast Track designation for HIV and metastatic cancer treatments, demonstrating its potential in multiple therapeutic areas.
CytoDyn Inc. (OTCQB: CYDY) announced an upcoming investment community webcast scheduled for June 21, 2021. CEO Nader Pourhassan, CMO Scott Kelly, and COO Christopher Recknor will discuss results from the recently unblinded COVID-19 long-haulers trial data. The presentation will also include updates on global COVID-19 trials, ongoing trials for NASH, cancer, and recent regulatory developments. The webcast is a 'listen only' format and will be archived for 30 days, providing a platform for analysts and investors to submit pre-webcast questions.
CytoDyn Inc. (CYDY) announced a significant advancement in the development of leronlimab, as it showed potential in preventing HIV infection through a study published in Nature Communications. The research indicated that leronlimab successfully prevented SHIV infection in nonhuman primates, paving the way for human trials as a pre-exposure prophylaxis (PrEP). The CEO expressed optimism about the drug’s future, highlighting its fewer side effects compared to current treatments and its potential in various therapeutic areas. CytoDyn is preparing to refile its Biologics License Application for HIV therapies soon.
CytoDyn (OTC.QB: CYDY) announced a collaboration with Philippine Airlines to fast-track the transportation of leronlimab, a treatment for critically ill COVID-19 patients, to the Philippines. CytoDyn has provided enough leronlimab to treat 100 patients at no cost under a Compassionate Special Permit. The partnership aims to expedite delivery from the U.S. to the Philippines, helping to save lives. Additionally, leronlimab is under investigation for HIV and metastatic cancer treatments and has received FDA Fast Track designation for both indications.
CytoDyn Inc. (OTC.QB: CYDY) announced a purchase order from Chiral Pharma Corporation in the Philippines for leronlimab, a treatment for critically ill COVID-19 patients. The order follows a Compassionate Special Permit and is expected to generate revenue upon fulfillment. The COO noted a significant 21% mortality rate among patients treated under CSP, with success stories highlighting improvements post-treatment. CytoDyn is also preparing an Emergency Use Authorization application in the Philippines amid ongoing clinical trials targeting HIV, cancer, and long-term COVID-19 symptoms.
CytoDyn Inc. (OTC.QB: CYDY) has announced plans by its Brazilian distribution partner, Biomm S.A., to submit an authorization request to the Brazilian National Health Surveillance Agency (ANVISA) for two Phase 3 clinical trials of leronlimab in treating COVID-19. The trials will target severe and critically ill patients with a total of 900 participants across 45 sites. CytoDyn aims to utilize leronlimab to potentially benefit thousands of COVID-19 patients in Brazil, while also preparing to explore similar partnerships in other countries facing COVID-19 surges.
CytoDyn Inc. (OTC.QB: CYDY) has promoted Antonio Migliarese to Chief Financial Officer, transitioning from Vice President, Corporate Controller. This change follows Michael Mulholland's shift to Senior Vice President of Finance for personal reasons. Migliarese, a CPA with extensive financial experience, will lead CytoDyn's financial organization as it evolves from a pre-revenue biotechnology company to a commercial entity. CytoDyn continues to develop its lead product, Vyrologix™ (leronlimab-PRO 140), with FDA Fast Track designation for HIV and metastatic cancer treatments.
CytoDyn Inc. (OTC.QB: CYDY) announced positive topline results from its CD12 Phase 3 clinical trial focusing on leronlimab for critically ill COVID-19 patients. The study demonstrated significant improvements in mortality rates, showing a 78% reduction with the first dose and 82% with the second. Secondary endpoints were met with statistically significant p-values. Despite not achieving the primary endpoint in the mITT population, CytoDyn aims to submit these findings to regulatory agencies for potential approval in countries like India and the Philippines.
CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast scheduled for May 18, 2021, led by CEO Nader Pourhassan and other executives. The presentation will address ongoing communications with the FDA regarding trial design, focusing on the CD12 trial results for the COVID-19 treatment, leronlimab. The trial did not meet primary endpoint criteria; however, secondary endpoints in a critically ill sub-population showed promise. Investors are encouraged to submit questions before and during the webcast.
CytoDyn Inc. (OTC.QB: CYDY) has signed an exclusive agreement with Macleods Pharmaceuticals Ltd. to distribute leronlimab in India, targeting COVID-19 patients. This partnership aims to address the lack of approved treatments for critically ill COVID-19 patients in India. The agreement was finalized swiftly, and both companies are optimistic about leronlimab's potential to save lives. CytoDyn has also completed a pivotal Phase 3 trial for leronlimab in HIV treatment and plans to resubmit its Biologics License Application by Q3 2021.
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