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.
CytoDyn Inc (CYDY) is a clinical-stage biotechnology company advancing leronlimab, an investigational CCR5-targeting therapy with applications in oncology, inflammation, and infectious diseases. This dedicated news hub provides investors and researchers with essential updates on clinical developments, regulatory milestones, and strategic partnerships.
Our curated collection features official press releases and verified news covering clinical trial results, FDA communications, and research collaborations. Users gain access to critical updates about leronlimab's development across multiple therapeutic areas, including ongoing studies in metastatic cancers and inflammatory conditions.
The resource emphasizes CytoDyn's progress in resolving historical challenges and establishing robust clinical protocols. Key content categories include trial design updates, partner announcements with organizations like Syneos Health, and regulatory pathway developments. All materials maintain strict adherence to factual reporting standards.
For those monitoring biopharmaceutical innovation, this page serves as a reliable source for tracking CytoDyn's evidence-based approach to drug development. Bookmark this hub to stay informed about new developments in CCR5-targeted therapies and the company's evolving clinical pipeline.
CytoDyn (OTCQB: CYDY) has appointed Dr. Melissa Palmer as Lead Consultant in Hepatology to drive the company's research and development strategy for liver conditions. Following promising initial results, CytoDyn has commissioned two follow-up studies with SMC Laboratories to confirm fibrosis reversal observations, with results expected in early 2025. The studies will compare leronlimab alone and in combination with other therapies, including resmetirom and a GLP-1 agonist. Dr. Palmer, an internationally renowned hepatologist with over three decades of experience and previous interim CMO role at CytoDyn, will oversee these studies focusing on MASH and liver fibrosis treatments.
CytoDyn Inc. (OTCQB: CYDY) has appointed Dr. Max Lataillade as Senior Vice President and Head of Clinical Development. Dr. Lataillade, with over 20 years of research experience, will lead the company's global R&D strategy and oversee end-to-end R&D activities. He previously served as Vice President at ViiV Healthcare and Bristol-Myers Squibb, specializing in HIV research. Dr. Lataillade is also an assistant clinical professor at Yale University School of Medicine.
CytoDyn's CEO, Dr. Jacob Lalezari, expressed enthusiasm about the appointment, citing Dr. Lataillade's industry accomplishments and skillset as valuable assets for progressing the company's development pipeline. Dr. Lataillade aims to leverage his experience to pursue strategic development opportunities and advance CytoDyn's clinical pipeline, particularly focusing on the development of leronlimab, a CCR5 antagonist with potential for multiple therapeutic indications.
CytoDyn Inc. (OTCQB: CYDY) announced the acceptance of an abstract for presentation at the 5th annual HIV Research for Prevention Conference. The abstract highlights research on combining early antiretroviral therapy (ART) with broadly neutralizing antibodies (bNAbs) and leronlimab, a CCR5 antagonist, in infant rhesus macaques infected with Simian Human Immunodeficiency Virus (SHIV).
Key findings include:
- The study aimed to assess if this combination could provide sustained viral control without continuous ART
- 18 infant rhesus macaques were treated with various combinations of ART, bNAbs, and leronlimab
- No virus rebound was observed in treated animals over a 27-week period
- Results suggest potential for durable viral control and reduced need for ongoing ART
The study, funded by an NIH grant to OHSU, will be presented by Dr. Jonah B. Sacha at the conference in Lima, Peru on October 10, 2024.
CytoDyn Inc. (OTCQB: CYDY) has engaged Syneos Health as the contract research organization (CRO) for its upcoming Phase II oncology trial. The trial will evaluate the efficacy of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (CRC). Syneos Health is a leading biopharmaceutical solutions organization with advanced data analytics and AI/ML capabilities.
Dr. Jacob Lalezari, CEO of CytoDyn, stated that investigating leronlimab in oncology remains their top priority. The company expects to generate clinical data affirming the utility of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab. CytoDyn submitted the final study protocol to the FDA for approval in September 2024 and anticipates starting patient screening in early 2025.
CytoDyn Inc. (OTCQB: CYDY) has announced preliminary findings from a preclinical study conducted by SMC Laboratories on leronlimab, its CCR5 antagonist. The study assessed optimal dosing for MASH (Metabolic dysfunction-Associated Steatohepatitis) and potential synergies with Resmetirom. Key findings include:
1. Leronlimab monotherapy (700 mg) showed statistically significant fibrosis reversal compared to control (p<0.01).
2. Dose-dependent antifibrotic activity was observed, with 700 mg performing better than 350 mg.
3. Leronlimab (700 mg) appeared to have better anti-fibrotic activity than Resmetirom (p=0.057).
Dr. Jacob Lalezari, CEO of CytoDyn, expressed excitement about the results, stating they confirm leronlimab's potential to benefit patients with various medical concerns. The company is in discussions with SMC Laboratories regarding next steps, including supplemental studies to expand on these findings and advance their clinical pipeline.
CytoDyn Inc. (CYDY) has made significant progress in 2024, as outlined in the September shareholder letter. Key developments include:
- FDA lifting the clinical hold on leronlimab in March 2024
- Submission of two clinical trial protocols to the FDA
- Settlement with Amarex, resulting in a $10 million cash influx
- Initiation of pre-clinical and clinical leronlimab trials
- Progress on developing a longer-acting therapeutic with an AI partner
The company is focusing on oncology, with a Phase II study in colorectal cancer and exploration of triple-negative breast cancer and glioblastoma. In inflammation, CytoDyn is evaluating leronlimab for HIV-related chronic inflammation, Alzheimer's Disease, and chronic fatigue syndrome. Other areas include MASH and HIV cure research. The company believes it has sufficient cash to commence clinical trials and advance development initiatives into 2025.
CytoDyn Inc. (OTCQB: CYDY) has announced the engagement of Syneos Health as the contract research organization (CRO) for its upcoming Phase II study on leronlimab's effects on chronic inflammation. Syneos Health is a leading biopharmaceutical solutions provider with a strong track record, having contributed to the development or commercialization of 92% of novel new drugs approved by the FDA in the last five years (2019-2023) and 91% of products granted marketing authorization by the European Medicines Agency.
Dr. Jacob Lalezari, CEO of CytoDyn, expressed optimism about the collaboration, stating that their goal is to generate clinical data that will affirm leronlimab's utility in addressing various medical concerns impacting patients globally.
CytoDyn Inc. (OTCQB: CYDY) has completed a meeting with the FDA regarding its planned Phase II study of leronlimab in relapsed/refractory microsatellite stable colorectal cancer patients. The study will investigate leronlimab's safety and activity in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab. The trial will be an open-label, randomized (1:1), multicenter study evaluating leronlimab doses of 350 mg and 700 mg in approximately 60 patients with CCR5+, microsatellite stable metastatic CRC (mCRC). Patients must have measurable disease and prior treatment with specific chemotherapies. The company plans to submit its final study protocol to the FDA and engage a clinical research organization (CRO) to initiate the trial in the coming months.
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.
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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