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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: CYDY) announced that its director candidate, Dr. Bruce Patterson, presented at the International COVID Summit in Rome from September 12-14, 2021. The summit gathered noted medical researchers to discuss treatment experiences globally. Dr. Patterson's invitation underscores his leadership in COVID treatment and long-hauler research. The Nominating Stockholders emphasized the importance of Dr. Patterson's expertise as the company seeks FDA approval for Leronlimab, aiming to enhance patient care and create long-term shareholder value.

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CytoDyn Inc. (OTCQB: CYDY) announced that CEO Nader Pourhassan and CMO Scott Kelly will present a business update at the Emerging Growth Conference on September 15, 2021, from 3:30 PM to 4:30 PM ET. The presentation will focus on leronlimab, a CCR5 antagonist under development for HIV and metastatic cancer. The FDA has granted Fast Track designation for leronlimab for HIV and metastatic triple-negative breast cancer. Participants can access the live stream and a recording on CytoDyn's website shortly after the event.

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CytoDyn Inc. (OTCQB: CYDY) has commenced the pivotal Phase 3 COVID-19 trial in Brazil, treating the first patient with leronlimab, a CCR5 antagonist. The trial targets 612 patients needing oxygen support across 35 sites. An interim analysis will occur 28 days after enrolling 245 patients. The trial aims to provide ANVISA with data for potential approval. CEO Nader Pourhassan expressed optimism about the trial and highlighted the team's past successes. The company continues to explore leronlimab for HIV, metastatic cancer, and other conditions, with promising results in clinical studies.

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The Nominating Stockholders of CytoDyn Inc. (CYDY) have nominated five director candidates for the Company’s Board. They responded to CYDY's September 3, 2021 release, claiming it misrepresented a voluntary stipulation filed by the Nominating Stockholders in ongoing litigation. They argue that CYDY’s actions are a distraction from management issues and an attempt to prevent shareholders from voting for an alternative slate. The Nominating Stockholders emphasize their commitment to securities laws and encourage shareholders to focus on significant issues affecting the Company.

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CytoDyn Inc. (OTCQB: CYDY) will host a webcast on September 8, 2021, at 1:00 pm PT to discuss recent trial data, particularly from the mTNBC trials, and updates on COVID-19 and NASH trials. The management team, including CEO Nader Pourhassan and CMO Scott Kelly, will also address the status of the resubmission of the BLA for HIV. Participants are encouraged to submit questions in advance via email. The webcast will be available for listening on CytoDyn's corporate website and will be archived for 30 days after the event.

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The Board of Directors of CytoDyn (OTC-PINK: CYDY) addressed the recent Court Order regarding the activist group led by Paul Rosenbaum and Bruce Patterson. The Court found that their email solicitations violated SEC rules, mandating compliance with federal securities laws. CytoDyn's Board emphasized the group's pattern of misleading shareholders and failing transparency. They urged shareholders to disregard future communications from the group and clarified the validity of their nominations for the annual meeting scheduled for October 6, 2021.

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A group of long-time stockholders of CytoDyn Inc. (OTC: CYDY) has criticized the company's current leadership for their destructive public relations campaign and inability to secure FDA approval for Leronlimab. They argue that these actions have damaged the company's value and credibility, urging fellow shareholders to vote for their five experienced director nominees using the WHITE proxy card. The group claims their leadership will implement strategies to restore value and generate revenue while emphasizing the importance of shareholder votes.

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CytoDyn Inc. (OTCQB: CYDY) announced the appointment of Dr. Seenu Srinivasan as Executive Director-CMC Regulatory Affairs, bringing over 30 years of regulatory and drug development experience. Dr. Srinivasan previously served at Regeneron Pharmaceuticals, where he led the CMC strategy for the approved drug Dupixent. His expertise encompasses process development, formulation, and regulatory filing, which are crucial for advancing CytoDyn's investigational monoclonal antibody, leronlimab, aimed at treating HIV, metastatic cancer, and other conditions. The company emphasizes the significance of this appointment in achieving its strategic goals.

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A group of long-time stockholders of CytoDyn Inc. (CYDY) filed a lawsuit in the Delaware Court of Chancery to allow voting on their nominated director candidates. The lawsuit challenges CYDY's previous actions to block shareholders from voting and claims the current Board has failed to secure FDA approval for Leronlimab, impacting the Company's value. The Group seeks to reinvigorate CYDY's leadership with five highly qualified nominees to pursue FDA approval and enhance shareholder value.

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CytoDyn Inc. urges shareholders to ignore proxy cards from the Rosenbaum/Patterson Group, claiming these may result in disenfranchised votes. The company emphasizes that its board rejected the Group's director nominations, which are considered invalid. A federal court has granted CytoDyn an expedited discovery in ongoing litigation regarding the Group's proxy materials. The company reassures shareholders they do not need to take action at this time and will provide official proxy materials shortly, allowing votes to be retracted if previously cast on the Group's card.

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FAQ

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

The current stock price of CYTODYN (CYDY) is $0.1158 as of December 26, 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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CYDY Stock Data

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