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. (OTC.QB: CYDY) has initiated a critical COVID-19 clinical trial protocol in the U.S. and is in discussions to start two similar trials in Brazil. The company submitted a key component of its application for an Interim Order to Health Canada for leronlimab's use in treating COVID-19, expecting to submit the remaining sections soon. Leronlimab is also undergoing trials for HIV and metastatic cancer, showing promise in reducing viral loads and tumor metastases. CytoDyn aims to expedite leronlimab's regulatory approvals and expand its therapeutic applications.
CytoDyn Inc. (OTC.QB: CYDY) announced that former Philippine President Joseph Estrada was treated with leronlimab under a Compassionate Special Permit for COVID-19. As he remains hospitalized, CytoDyn continues to supply leronlimab to the Philippines, collaborating with Chiral Pharma to potentially expand the permit. CEO Nader Pourhassan highlighted progress in trials for HIV and cancer, including plans for a resubmission of the Biologics License Application for HIV. Leronlimab's FDA Fast Track designations support its use against HIV and metastatic cancer, with positive outcomes in earlier trials.
CytoDyn Inc. (CYDY) has signed an exclusive supply agreement with Chiral Pharma Corporation to distribute 200,000 vials of leronlimab for critically ill COVID-19 patients in the Philippines under a Compassionate Special Permit. This rapid partnership aims to expedite treatment availability. CytoDyn is also working to leverage clinical trial data to seek Emergency Use Authorizations (EUAs) in other countries experiencing COVID-19 surges. The company's ongoing trials include those for HIV, metastatic breast cancer, and post-COVID syndromes, highlighting its diverse therapeutic approach.
CytoDyn Inc. (OTC.QB: CYDY) announced that its COVID-19 long-haulers study, known as CD15, is fully enrolled with 56 patients, surpassing expectations. This Phase 2 trial aims to evaluate the safety and efficacy of Vyrologix™ (leronlimab) for treating Post-Acute COVID Syndrome (PACS). Results are anticipated in July, with the trial concluding in early June. Given the pandemic's scale, an estimated 20-60 million patients could benefit from effective treatments. The FDA has previously granted Fast Track designation to leronlimab for HIV and metastatic cancer therapies.
CytoDyn Inc. (OTC.QB: CYDY) is delivering leronlimab to a Philippine hospital for 28 critically ill COVID-19 patients under a new Coordinated Special Project (CSP). The company is negotiating the potential future delivery of 100,000 vials to the Philippines. CytoDyn has received Fast Track designation from the FDA for leronlimab for HIV and metastatic cancer. The company has completed several clinical trials, including a pivotal Phase 3 trial for HIV, and is conducting trials for NASH and post-acute COVID-19 symptoms. CytoDyn aims to refile its Biologics License Application by mid-2021.
CytoDyn Inc. (OTC.QB: CYDY) has signed an exclusive supply and distribution agreement with Biomm S.A. to sell leronlimab in Brazil, pending regulatory clearances. Leronlimab, a CCR5 antagonist, is being investigated for various conditions including Long-Hauler COVID-19, NASH, and cancer. Biomm aims to provide leronlimab to critically ill COVID-19 patients. CytoDyn's CEO expressed excitement over this advancement for Brazilian patients and a long-term partnership with Biomm.
CytoDyn Inc. (OTC.QB: CYDY) has announced a rescheduled investment community webcast set for April 7, 2021. Key executives, including CEO Nader Pourhassan, will update stockholders on recent company activities, particularly focusing on COVID-19 initiatives and multiple ongoing clinical trials. The event aims to address investor inquiries, providing a platform for questions that can be submitted online. This 60-minute webcast is available on CytoDyn’s corporate website and will be archived for 30 days.
CytoDyn Inc. (OTC.QB: CYDY) announced the completion of a $25 million convertible debt offering with an institutional investor. The note matures in two years at 10% interest and is secured by company assets. This financing aims to support the availability of leronlimab for potential COVID-19 treatment approvals. CytoDyn is also progressing in its clinical trials for HIV and metastatic cancer. The FDA has granted Fast Track designation for leronlimab in treating HIV and metastatic triple-negative breast cancer, highlighting its promising therapeutic potential.
CytoDyn Inc. (OTC.QB: CYDY) announced significant improvement in the first Compassionate Special Permit (CSP) patient in the Philippines after receiving a 700 mg injection of Vyrologix™ (leronlimab) for COVID-19. The patient, previously on high-flow oxygen, was discharged from the hospital just 35 hours post-injection. CytoDyn plans to supply at least 100,000 doses of leronlimab pending Emergency Use Authorization in the Philippines. The company highlights the treatment's potential, backed by previous clinical trials showing a significant reduction in mortality among critically ill COVID-19 patients.
CytoDyn (CYDY) announced an investment community webcast on April 6, 2021, hosted by its executive team, including CEO Nader Pourhassan and CMO Scott Kelly. The update will cover the company's recent initiatives related to COVID-19, as well as ongoing trials for NASH and cancer treatments. The session will be approximately 60 minutes long, allowing for questions submitted by analysts and investors. Participants can access the webcast on CytoDyn's corporate website and a replay will be available for 30 days afterwards.
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?