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CYTODYN INC - CYDY STOCK NEWS

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of CYTODYN (CYDY)?

The current stock price of CYTODYN (CYDY) is $0.115 as of December 24, 2024.

What is the market cap of CYTODYN (CYDY)?

The market cap of CYTODYN (CYDY) is approximately 134.2M.

What operational and financial adjustments did the Company make in fiscal year 2023?

In fiscal year 2023, CYDY implemented significant reductions in its workforce, cash burn rate, and operating expenses to preserve resources and focus on critical corporate priorities. Workforce reductions, alongside expense reduction measures, led to improved cash burn and expense run rates.

What is the status of the clinical hold?

CYDY recently provided additional information to the FDA to address remaining questions and hopes for the removal of the clinical hold. The company stands ready to address further issues and is optimistic about a successful resolution.

What is the short-term development plan for leronlimab following the resolution of the clinical hold?

Post the resolution of the clinical hold, CYDY will focus on a multipronged therapeutic approach to leronlimab. Initiatives include KOL-identified studies in HIV, pre-clinical combination therapy trials in MASH and oncology, and potential partnership opportunities.

What is the current status of the longer-acting therapeutic project?

CYDY is collaborating with a partner utilizing AI technology to develop a long-acting therapeutic enhancing its existing IP portfolio and attracting partnership opportunities, potentially increasing shareholder value.

What is the current status of the CEO search?

The CEO search has narrowed to qualified candidates, with an expected new CEO appointment by the year-end to enhance the company's business strategies and drug commercialization efforts.

How does the Company make decisions regarding executive compensation?

The Compensation Committee of the Board reviews, appoints independent members, and oversees executive compensation plans annually based on recommendations from an independent executive compensation advisory firm, ensuring competitive industry standards and talent retention.

What is the current status of the Amarex litigation effort?

CYDY is pursuing litigation against Amarex for its failures in clinical trial management, fully funding legal representation by Sidley Austin LLP. The final arbitration hearing is scheduled for August 2024, demonstrating the Company's commitment to maximizing recovery.

What is the status of the new communication strategy?

CYDY is shifting its communication strategy to be clear, concise, and frequent, engaging with stakeholders, and responding to inquiries. The Company aims to provide updates via SEC filings, direct communications, and a planned FAQ section on its website.

What clinical trials is the Company currently working on?

CYDY is focused on conducting Phase II clinical trials, with priorities set on oncology trials and inflammation studies to clarify leronlimab's effectiveness. The Company is also exploring research and development partnerships to further enhance its product development portfolio.

Is leronlimab currently available to the public outside of a clinical trial?

Leronlimab, as an unapproved drug, is not available to the general public. However, certain patients facing critical illnesses may access early investigational drugs under Expanded Access or Right to Try programs, subject to FDA approvals and requirements.

CYTODYN INC

OTC:CYDY

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134.18M
1.21B
0.78%
0.03%
Biotechnology
Healthcare
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United States of America
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