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.
CYDY is a clinical-stage biotechnology company focused on developing leronlimab, a humanized IgG4 monoclonal antibody that targets CCR5, a protein on immune system cells. Having invested in clinical trials, CYDY aims to revolutionize treatment across multiple therapeutic areas including HIV, oncology, MASH, and MASLD. Despite facing challenges in FY23, the company took measures to conserve resources, reduce operating expenses, and position itself for near-term and long-term success. CYDY is focused on completing the resolution of the FDA's partial clinical hold and exploring various therapeutic indications for leronlimab to maximize patient and practitioner benefits.
CytoDyn Inc. (OTCQB: CYDY) announced its advancement in the clinical trial of leronlimab for metastatic triple-negative breast cancer, moving from Phase 1b to Phase 2. The trial will administer a 700 mg dosage in combination with carboplatin, with preliminary efficacy data expected in about two weeks. Leronlimab, targeting CCR5, has strong potential across various cancers and has previously achieved primary endpoints in HIV trials. The FDA has granted it Fast Track designation for both HIV and metastatic cancer indications, signaling regulatory support for CytoDyn's innovative approach.
CytoDyn Inc. (OTCQB: CYDY) announced the granting of U.S. Patent No. 11,045,546 for its drug candidate leronlimab, designed to treat coronavirus infections, particularly targeting hyperinflammation caused by SARS-CoV-2. This patent, expected to last until June 15, 2040, reflects the rapid approval process under the USPTO's COVID-19 Prioritized Examination Pilot Program. The patent claims methods for normalizing CD4/CD8 T cell ratios and enhancing CD8 T cell frequency in infected subjects. CytoDyn is advancing several clinical trials for leronlimab, including indications for HIV, COVID-19 long-haulers, and NASH.
CytoDyn (OTCQB: CYDY) announced the submission of a dose justification report to the FDA as part of its Biologics License Application (BLA) for leronlimab, aimed at HIV patients resistant to standard therapies. This report will guide the optimal dosage for the drug. CytoDyn plans to begin BLA module submissions following FDA feedback. The company is also progressing with clinical trials for COVID-19, NASH, and various cancers, with hopes for expanded therapeutic indications and ongoing evaluations. CEO Nader Pourhassan expresses optimism about leronlimab's future, highlighting its potential across multiple diseases.
A group of long-time stockholders in CytoDyn Inc. (CYDY) has nominated five candidates for the Company’s Board of Directors, citing ineffective leadership and failures regarding the Leronlimab drug. The nominees, who include medical professionals and business leaders, aim to replace the current management team to secure FDA approval for Leronlimab and enhance shareholder value. The Nominating Stockholders have also launched a dedicated website for updates and plans to file a proxy statement with the SEC for the solicitation of proxies from other stockholders.
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.
FAQ
What is the current stock price of Cytodyn (CYDY)?
What is the market cap of Cytodyn (CYDY)?
What operational and financial adjustments did the Company make in fiscal year 2023?
What is the status of the clinical hold?
What is the short-term development plan for leronlimab following the resolution of the clinical hold?
What is the current status of the longer-acting therapeutic project?
What is the current status of the CEO search?
How does the Company make decisions regarding executive compensation?
What is the current status of the Amarex litigation effort?
What is the status of the new communication strategy?
What clinical trials is the Company currently working on?
Is leronlimab currently available to the public outside of a clinical trial?
