Cytodyn Inc Stock Price, News & Analysis

CytoDyn Inc. (OTC.QB: CYDY) has partnered with Albert Einstein Israelite Hospital in São Paulo, Brazil, to conduct two Phase 3 COVID-19 trials aimed at seeking regulatory approval from ANVISA for leronlimab. These trials will enroll about 1,500 patients across 45 sites, with an interim analysis planned when 120 critically ill patients are enrolled. The Brazilian COVID-19 crisis intensifies with ICU capacity nearing full. CytoDyn believes these trials may facilitate Emergency Use Authorization (EUA) for leronlimab globally. The company plans to update shareholders on trial progress shortly.

CytoDyn Inc. (OTC.QB: CYDY) announced on May 3, 2021, an upcoming webcast scheduled for May 5, 2021, featuring CEO Nader Pourhassan, CMO Scott Kelly, and COO Chris Recknor. The session aims to provide stockholders with updates on the company's priorities, particularly its COVID-19 initiatives and ongoing trials related to COVID-19, NASH, and cancer. Investors can submit questions online for discussion during the one-hour session, which will be accessible through the company's corporate website.

CytoDyn Inc. (OTC.QB: CYDY) has announced plans for a pre-Breakthrough Therapy designation meeting to expedite preparations for a Phase 3 clinical trial involving leronlimab for 22 solid tumor cancer indications. Encouraging results from preliminary trials suggest potential for a reduced trial size. The company is optimistic about leronlimab's ability to control cancer metastasis and its role in immunotherapy. Additionally, CytoDyn is preparing to resubmit its Biologics License Application (BLA) for HIV treatment, following previous setbacks.

CytoDyn Inc. (OTC.QB: CYDY) announced progress on its HIV treatment, leronlimab, following positive results from three ongoing clinical trials. Approximately 120 patients remain in treatment extensions, with no significant safety issues reported over 4-7 years in 66 open-label patients. The company is on track to submit a Biologics License Application (BLA) for HIV therapy by July 2021, aiming to expedite additional indications, including cancer and COVID-19. Leronlimab has shown promise in controlling HIV viral load, indicating a potential breakthrough in treatment options.

CytoDyn Inc. (OTC.QB: CYDY) announced that Scott Kelly, M.D., will present on leronlimab at the Triple Negative Breast Cancer Drug Development Digital Summit 2021 on April 28. This exclusive event aims to discuss leronlimab's potential in treating triple-negative breast cancer (TNBC), with encouraging early indications noted. The FDA has granted leronlimab Fast Track designation for HIV and metastatic cancer indications. CytoDyn is conducting multiple clinical trials to explore its efficacy across various diseases.

CytoDyn Inc. (OTC.QB: CYDY) announced it secured $57 million in financing, with a recent $25 million convertible debt offering. The note has a two-year maturity at 10% interest, convertible at $10 per share. CytoDyn continues to focus on key therapeutic areas, including COVID-19 and HIV, with significant progress in its clinical trials. Key highlights include the expectation of HIV BLA resubmission by Q3 2021 and ongoing trials for long-haulers and NASH. The company has raised nearly $500 million, reflecting strong market confidence.

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.