CytoDyn Inc (OTCQB:CYDY), which is developing leronlimab (PRO 140) to battle multiple diseases including coronavirus (COVID-19), has filed to uplist its stock to the tech-laded Nasdaq stock exchange.
In a statement, the Vancouver, Washington-based company said it believes its comprehensive application package satisfies the initial listing requirements for The Nasdaq Capital Market.
“While we realize the regulatory review of our application to uplist to Nasdaq will take several weeks, we believe the company is well-positioned for success,” noted CEO Nader Pourhassan.
“As we advance the evaluation of our drug, leronlimab, including the upcoming results of the COVID-19 trials, we believe a listing on Nasdaq will enhance shareholder value by providing our shareholders with improved liquidity and by giving us greater access to the capital markets, which will allow us to achieve our objective of bringing leronlimab to market,” Pourhassan added.
As a possible COVID-19 treatment, the US Food and Drug Administration has granted a so-called rolling review for leronlimab as part of CytoDyn's application submission. The company has been granted more than 60 emergency Investigational New Drug authorizations by the FDA and plans to provide clinical updates for this patient population in the coming weeks.
In July, CytoDyn started enrolling a Phase 2b/3 clinical trial for 390 severe and critically ill COVID-19 patients, which were randomized in a 2:1 ratio, in an active drug to placebo-controlled trial.
CytoDyn also said it has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical study for mild-to-moderate COVID-19 patients in the US.
Leronlimab has also been granted Fast Track designation by the FDA for the treatment of HIV in combination with highly active antiretroviral therapy (HAART,) and for metastatic triple-negative breast cancer, a rare variety which doesn’t respond to some treatments.
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