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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 submitted a protocol to the U.S. FDA for the immediate enrollment of 140 critical COVID-19 patients, aiming to support a potential Emergency Use Authorization (EUA) for leronlimab. The FDA is reviewing this submission while the Company explores regulatory pathways in the U.K. and Canada. Preliminary data indicates leronlimab may significantly impact mortality rates among elderly patients. With a Fast Track designation, CytoDyn is focusing on enhancing accessibility of leronlimab for COVID-19 treatment amidst ongoing trials and regulatory discussions.

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CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast on March 8, 2021, to discuss data from its Phase 3 trial for severe-to-critically ill COVID-19 patients. Management, including CEO Nader Pourhassan and CMO Scott Kelly, will outline the regulatory path forward across multiple countries and provide updates on clinical and corporate priorities. The webcast will allow for 90 minutes of Q&A, accessible via CytoDyn's website.

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CytoDyn Inc. (OTC.QB: CYDY) announced positive results from its Phase 3 trial of leronlimab for treating critically ill COVID-19 patients. The study showed a 24% reduction in mortality and a 6-day shorter hospital stay compared to placebo. Additionally, the probability of being 'discharged alive' at Day 28 was 28% for leronlimab patients against 11% for the placebo group. The Company is in discussions with regulatory agencies to expedite approval. These outcomes highlight leronlimab’s potential as a safe and effective treatment for this vulnerable patient group.

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CytoDyn Inc. (OTC.QB: CYDY) announced a new “universal shelf” registration statement on Form S-3 with the SEC, replacing the previous registration expiring on March 7, 2021. This allows CytoDyn to maintain registration of unexercised warrants and provides flexibility for future capital access. No immediate plans to offer securities exist, and no sales can occur until the registration becomes effective. The shelf registration has been active since 2016, enabling timely capital market access.

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CytoDyn Inc. (OTC.QB: CYDY) has unblinded the data from its CD12 clinical trial for COVID-19 and expects to conclude discussions with regulatory agencies within 2 to 3 weeks. The trial involved 394 patients and evaluated the efficacy of Vyrologix™ (leronlimab-PRO 140). The FDA has granted leronlimab Fast Track designation for treatment of critical illnesses, including a combination therapy for HIV and metastatic triple-negative breast cancer. The company anticipates refiling its Biologics License Application in the first half of 2021.

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CytoDyn (OTC.QB: CYDY) announced its collaboration with Chiral Pharma Corp. to provide 200,000 vials (100,000 doses) of leronlimab for potential sales in the Philippines, specifically targeting COVID-19 patients. The company seeks a Compassionate Special Permit (CSP) for registration, aiming to conduct trials and gather data from Philippine patients receiving the treatment. CytoDyn's Phase 2 clinical trial for COVID-19 showed significant results, with expectations to release more data soon. The FDA has granted Fast Track designation for leronlimab for critical medical conditions.

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CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast on October 20, 2020, at 2:00 pm PT to discuss the Data Safety Monitoring Committee's recommendations following an interim analysis of 195 patients in its Phase 2b/3 clinical trial for severe-to-critical COVID-19. The webcast will feature a presentation and a Q&A session. The event is accessible via the company's website and will be archived for 30 days after the event.

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CytoDyn Inc. (OTC.QB: CYDY) announced an upcoming investment community webcast on October 20, 2020, to discuss recommendations from the Data Safety Monitoring Committee (DSMC) based on an interim analysis of the Phase 2b/3 trial for severe-to-critical COVID-19. Key management, including President Nader Pourhassan, will provide insights into a potential regulatory path forward. The webcast will feature a presentation followed by a Q&A session. Access will be through CytoDyn's corporate website, with replay available for 30 days.

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CytoDyn (OTC.QB: CYDY) announced the appointment of Chiral Pharma Corporation to register leronlimab (PRO 140) for potential COVID-19 treatment approval in the Philippines. The company is conducting Phase 2 and Phase 3 trials for COVID-19, with interim results expected mid-October. Leronlimab has received Fast Track designation for indications in HIV and metastatic triple-negative breast cancer. The drug has shown promising results in multiple clinical trials, significantly reducing HIV viral load and tumor metastasis.

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CytoDyn Inc. (OTC.QB: CYDY) announces its 2020 Virtual Annual Meeting of Stockholders, scheduled for September 30, 2020, at 9:30 am PT. Due to health concerns from the coronavirus pandemic, in-person attendance is not allowed. Stockholders can log in to participate via the provided webcast link, and questions can be submitted online during the meeting with the passcode CYDY2020. Dr. Nader Pourhassan, CEO, will present a company overview post-business session, with materials available on the company website.

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FAQ

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

The current stock price of CYTODYN (CYDY) is $0.1175 as of December 23, 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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