CYTODYN INC - CYDY STOCK NEWS

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.

CytoDyn has received FDA approval to initiate a Phase 3 clinical trial assessing leronlimab for critically ill COVID-19 patients requiring invasive mechanical ventilation or ECMO. The trial will randomly assign patients to receive up to four IV doses of 700 mg leronlimab or placebo alongside standard care. The company aims to address the urgent need for effective COVID-19 treatments as cases surge in the U.S. Leronlimab has previously shown positive outcomes in early trials, with over 100 eINDs accepted by the FDA.

CytoDyn (OTCQB: CYDY) announced preliminary results from its Phase 2 trial for treating NASH with leronlimab. Over 14 weeks, patients showed an average cT1 reduction of 31.2 msec. Notably, 5 of 6 patients with severe NASH experienced an average cT1 drop of 108 msec and a 20% reduction in fatty deposits. The trial, involving 20 patients, aims to assess the drug's efficacy against liver fibrosis, with broader implications for the urgent need for NASH treatments, as no FDA-approved options currently exist.

CytoDyn Inc. (OTCQB: CYDY) will host an investment community webcast on December 14, 2021, featuring key executives discussing the company's developments, particularly on leronlimab, a CCR5 antagonist. The 60-minute session includes a 20-minute presentation followed by a 40-minute Q&A segment. CytoDyn is focused on advancing its BLA for HIV therapy and exploring further indications for leronlimab, including potential treatments for COVID-19 long-haulers and various solid tumors. More details can be found on their official site.

CytoDyn has engaged the FDA regarding the development of leronlimab for critically ill COVID-19 patients, finding the project's feasibility promising amid a decline in hospitalizations. The company has submitted a Phase 3 clinical trial to evaluate leronlimab's efficacy combined with standard care for patients needing invasive mechanical ventilation or ECMO. Prior Phase 3 results indicated an 82% survival rate in a subgroup after two doses. The new trial aims for improved outcomes with four doses. CytoDyn remains optimistic about its pipeline across various therapeutic areas.

CytoDyn has requested FDA approval for expanded access to use leronlimab in multi-drug resistant (MDR) HIV patients. This follows a successful Phase 3 trial showing an 81% success rate in suppressing viral load, significantly outperforming existing treatments (45%). Nearly all participants in the trial requested continued treatment. If approved, this will provide crucial access for MDR HIV patients needing alternative therapies. CytoDyn is also preparing to finalize its request to charge for the drug in this context.

CytoDyn Inc. has announced that its Clinical Research Organization (CRO) in Brazil received approval from the Brazilian Health Regulatory Agency (ANVISA) to modify the CD16 trial for critically ill COVID-19 patients. The modification reduces total enrollment from 330 to 126 patients, with an interim analysis after 51 patients complete follow-up. The trial employs four doses of 700 mg of leronlimab via IV infusion. Previous results showed an 82% survival benefit after two doses, and the company aims to leverage this for improved outcomes.

CytoDyn has completed submission of essential CMC modules for its Biologics License Application (BLA) for HIV to the FDA, with only the clinical section pending.

The submission is being processed under a rolling review, reflecting progress after previous challenges. The company is excited about upcoming submissions related to COVID-19 long-haulers and HIV data.

Additional efforts include a request for expanded use of leronlimab for multi-drug resistant HIV patients. CytoDyn aims for a successful operational year in 2022.