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.
CytoDyn (CYDY) announced a $5 million grant awarded to Oregon Health & Science University (OHSU) for preclinical research on a gene therapy based on leronlimab aimed at providing a functional cure for HIV. The study will examine the potential of a single-injection gene therapy utilizing adeno-associated virus (AAV) vectors to express the leronlimab protein, possibly eliminating the need for lifelong antiretroviral treatments. The research could pave the way for innovative anti-HIV therapies, aligning with NIH's ongoing efforts in HIV management.
CytoDyn (OTCQB: CYDY) announced that key executives, including Board Chair Tanya Urbach and CFO Antonio Migliarese, will host a webcast on June 30, 2022, to update the investment community. The presentation will provide a quarterly update regarding the company’s progress and developments, focusing on leronlimab, a CCR5 antagonist under development for multiple therapeutic uses. Participants can submit questions ahead of the event and access the replay afterward until July 30, 2022.
CytoDyn Inc. (OTCQB: CYDY) announced a non-cash settlement with former Chief Medical Officer Dr. Richard Pestell related to ongoing legal disputes. The agreement involves releasing claims, returning 8.3 million shares held in escrow, assets from ProstaGene LLC, and a warrant for 7 million shares at $0.37 each. The company aims to restore credibility and seeks to reengage Dr. Pestell to enhance the development of leronlimab, a potential therapeutic for various diseases, including cancer. CFO Antonio Migliarese expressed optimism about utilizing Dr. Pestell's expertise.
CytoDyn Inc. (OTCQB: CYDY) announced the addition of four prominent figures to its Scientific Board of Advisors, enhancing its expertise in biotechnology and immunotherapy. Dr. Paul Edison, Dr. Kabir Mody, and Dr. Otto Yang bring extensive backgrounds in neuroscience, oncology, and T cell immunology, respectively. Dr. Jacob (Jay) Lalezari will serve as an outside Scientific Advisor without compensation. These appointments aim to advance the development of leronlimab, a CCR5 antagonist under investigation for various therapeutic uses, including cancer and infectious diseases.
CytoDyn Inc. (OTCQB: CYDY) announced the publication of a peer-reviewed study in PLOS Pathogens demonstrating the efficacy of their CCR5 antagonist, leronlimab, in managing HIV. The study tracked five HIV+ patients who maintained viral suppression on leronlimab monotherapy for over seven years, despite a higher incidence of transient viral blips compared to traditional therapies. Additionally, research in rhesus macaques showed leronlimab reduced SHIV viral loads significantly. The company continues its focus on multiple therapeutic indications for leronlimab.
CytoDyn Inc. (OTCQB: CYDY) announced a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program by the FDA. The company will not enroll new patients in the affected trials, and those currently enrolled will be transitioned to alternative therapies. CytoDyn has paused its COVID-19 trials in Brazil while evaluating the situation and is reassessing the timing of its HIV BLA resubmission. The company plans to work closely with the FDA to resolve these issues promptly and will provide updates as information becomes available.
CytoDyn Inc. (OTCQB: CYDY) announced a webcast for the investment community on March 31, 2022, featuring key executives, including Board Chair Tanya Urbach and CFO Antonio Migliarese. The session aims to update stakeholders on the company's developments concerning leronlimab, a CCR5 antagonist with potential for various therapeutic uses. Participants can submit questions beforehand at ir@cytodyn.com. The event will begin at 5:30 am PT / 8:30 am ET, with a recorded replay available until April 30, 2022.
CytoDyn Inc. announced a leadership transition plan following the termination of Nader Z. Pourhassan as President and CEO, effective January 24, 2022. Antonio Migliarese, previously CFO, has been appointed interim President while retaining his role as CFO. The Board has initiated a search for a new permanent CEO with pharmaceutical experience to advance the regulatory approval and commercialization of leronlimab. Scott A. Kelly will step down as Chairman but remain on the Board, with Tanya Durkee Urbach taking over as Chairman. The executive team remains committed to the Company's objectives.
CytoDyn Inc. (OTCQB: CYDY) has announced the cancellation of its webcast scheduled for January 13, 2022, with plans to provide updates at a future date. The company is focused on developing leronlimab, a CCR5 antagonist aimed at treating HIV and metastatic cancer. FDA has granted Fast Track designation for leronlimab in two indications: HIV combination therapy and metastatic triple-negative breast cancer (mTNBC). CytoDyn has conducted 16 clinical trials with over 1,200 participants and aims to resubmit its Biologics License Application for leronlimab in the near future.
CytoDyn Inc. (OTCQB: CYDY) announces an investment community webcast on January 13, 2022, to discuss updates on NASH data, cancer, COVID-19, HIV BLA, and the company's financials. Key figures participating include CEO Nader Pourhassan and CMO Scott Kelly, among others. The discussion will last 60 minutes, including a live Q&A session. CytoDyn is developing leronlimab, a CCR5 antagonist with multiple therapeutic applications, and aims to resubmit its BLA for HIV therapy by Q1 2022 after previous setbacks.
FAQ
What is the current stock price of CYTODYN (CYDY)?
What is the market cap of CYTODYN (CYDY)?
What operational and financial adjustments did the Company make in fiscal year 2023?
What is the status of the clinical hold?
What is the short-term development plan for leronlimab following the resolution of the clinical hold?
What is the current status of the longer-acting therapeutic project?
What is the current status of the CEO search?
How does the Company make decisions regarding executive compensation?
What is the current status of the Amarex litigation effort?
What is the status of the new communication strategy?
What clinical trials is the Company currently working on?
Is leronlimab currently available to the public outside of a clinical trial?
