Cytodyn Inc Stock Price, News & Analysis

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.

CytoDyn (OTCQB: CYDY) announced significant developments regarding its lead drug, leronlimab, in treating HIV. The company achieved a primary endpoint in a pivotal Phase 3 trial involving heavily treatment-experienced (HTE) patients, with over 20 individuals remaining in an extension study for up to four years. Findings from a study demonstrating leronlimab's activity against 4-class drug-resistant HIV-1 will be included in its Biologics License Application (BLA) submission. Notably, leronlimab showcases potential benefits over other treatments, such as lower toxicity and less frequent dosing.

CytoDyn Inc. announced positive results from its Phase 2 clinical trial for leronlimab, a potential treatment for nonalcoholic steatohepatitis (NASH). The trial achieved its primary endpoint (PDFF) for the 350 mg weekly dose, with statistically significant results compared to placebo. The secondary endpoint (cT1) also showed near significance. This short 14-week trial demonstrates the potential of leronlimab, especially as there are no approved pharmacological therapies for NASH. Further analysis of biomarker data is ongoing to understand responder rates.

CytoDyn has secured a court ruling allowing access to clinical trial data from its former Contract Research Organization, Amarex. The U.S. District Court for the District of Maryland granted a preliminary injunction requiring Amarex to provide CytoDyn with full access to its electronic data capture systems. The ruling follows allegations that Amarex breached contractual obligations, causing significant damages. CytoDyn must post a $6.5 million bond by January 14, 2022. The company is developing leronlimab, targeting multiple indications, including HIV and metastatic cancer.