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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 has settled its lawsuit with Amarex Clinical Research, resulting in a $12 million cash payment to CytoDyn and the elimination of a $14 million accounts payable liability. This settlement was reached to resolve all legal claims between the parties, with no additional payment required from CytoDyn. The settlement also includes the release of a $6.5 million surety bond to CytoDyn. The company believes this outcome substantially strengthens its balance sheet, providing immediate non-dilutive cash and eliminating a significant liability. CytoDyn plans to utilize these resources to further its clinical trials and research initiatives.

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CytoDyn, a biotechnology company working on leronlimab, announced the start of a preclinical MASH study with SMC Laboratories. The study aims to clarify optimal dosing and evaluate combination therapy potential, with results expected in Fall 2024. The study will assess leronlimab's effectiveness in preventing or reversing liver fibrosis at 350 and 700 mg doses, alone and combined with Resmetirom. CytoDyn's CEO, Dr. Jacob Lalezari, emphasized this study's importance for future partnerships in the MASH space, even as the company focuses on oncology and inflammation therapies.

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CytoDyn, a biotechnology company developing the CCR5 antagonist leronlimab, announced a webcast scheduled for May 30, 2024. The event, led by CEO Dr. Jacob P. Lalezari, will feature updates on clinical trials, research collaborations, and development opportunities. Key executives including Tanya Urbach, Mitch Cohen, Tyler Blok, and Scott Hansen will join. The webcast is accessible online, and a replay will be available until June 30, 2024. No Q&A session will occur, but questions can be submitted via email.

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CytoDyn's CEO, Dr. Jay Lalezari, updates shareholders on key 2024 fiscal year achievements, including the lifting of the FDA clinical hold in February 2024. The company is working towards initiating clinical trials for leronlimab, focusing on relapsed/refractory microsatellite stable colorectal cancer and its anti-inflammatory effects.

Partnerships and research initiatives, such as studies on Alzheimer's and HIV, are in progress. The company has submitted multiple leronlimab manuscripts for peer review and continues to explore new research and development partnerships. Dr. Lalezari emphasizes the company's commitment to shareholders and the potential of leronlimab as a breakthrough therapeutic.

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CytoDyn Inc. announces FDA lifting the clinical hold on leronlimab for HIV clinical trial. CEO Dr. Jacob Lalezari to host webcast for company update on March 5, 2024.
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CytoDyn Inc. (CYDY) has submitted a revised HIV clinical trial protocol to the FDA, aiming to remove the clinical hold currently in effect. The company's CEO, Dr. Jacob Lalezari, highlighted the potential of leronlimab in addressing increased inflammation and immune activation in HIV patients, with implications for heart attacks, strokes, and other vascular events. Additionally, CytoDyn's research partnership with Albert Einstein College of Medicine and Montefiore Medical Center is progressing with a pre-clinical trial for studying leronlimab in glioblastoma, a common and often untreatable form of primary brain cancer, with preparations underway for a trial in 2024.
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CytoDyn Inc. announced the appointment of Dr. Jacob Lalezari as CEO and Mitchell Cohen as interim CFO. Dr. Lalezari's appointment follows a competitive search process, and he expressed optimism about the company's clinical protocol in HIV+ subjects. The company also expressed confidence in Mr. Cohen's ability to lead financial operations.
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CytoDyn Inc. (CYDY) to host an investment community webcast on December 14, 2023, to provide a Company update on leronlimab, a potential CCR5 antagonist with multiple therapeutic indications.
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CytoDyn Inc. (CYDY) appoints Dr. Jacob Lalezari as interim CEO. Dr. Lalezari brings 34 years of industry experience and will lead corporate and product development, focusing on short-term clinical development and fundraising. His extensive experience in clinical studies of viral diseases makes him a valuable addition to the company's leadership.
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CytoDyn Inc. provides an update on its progress in developing leronlimab for multiple therapeutic indications. The company has faced delays in satisfying the FDA's clinical hold submission requirements, but has gained new insights and engaged with key opinion leaders in the HIV treatment field. CytoDyn has implemented cost-cutting measures and is focused on resolving the clinical hold and strengthening its leadership team. The company is also exploring potential indications for leronlimab and is involved in ongoing litigation. Shareholders are encouraged to vote on increasing the total number of authorized shares of common stock.
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FAQ

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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147.14M
980.77M
0.8%
0.03%
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