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CytoDyn asks regulator to review its application to license leronlimab for HIV treatment under priority designation

Under current legislation, the US Food & Drug Administration has agreed to improve the time drugs are reviewed in

CytoDyn Inc. -
The FDA has already granted a 'Fast Track' designation to CytoDyn for two potential indications of leronlimab for deadly diseases

CytoDyn Inc (OTCQB:CYDY) said it has asked the US Food & drug Administration (FDA) to look at the group's application to license its leronlimab drug as a combination therapy for HIV as a "priority review".

Under current legislation, the FDA has agreed to improve the time drugs are reviewed and has created a two-tiered system, comprising a standard and a priority review.

READ: CytoDyn unveils further clinical trial plans in bid to fight coronavirus pandemic

A 'priority' designation means the regulator aims to take action on an application within six months, versus 10 months under a standard review.

"We look forward to the FDA’s decision on our important request and are hopeful that we can bring leronlimab therapy to highly treatment experienced HIV patients by late 2020," Nader Pourhassan, the president and chief executive at CytoDyn said in a statement.

"Leronlimab’s potential for many other indications could be expedited, should the company receive its first approval. All other potential indications (and we believe there are many) could have a much faster approval process as label expansion approvals.”

A priority review considers drugs that, if approved, would make significant improvements to the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

Leronlimab is a monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.

The FDA has already granted a 'Fast Track' designation to CytoDyn for two potential indications of leronlimab for deadly diseases.

The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.

CytoDyn is currently enrolling patients in two clinical trials for coronavirus (COVID-19) using leronlimab. One is a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the USA.

The second is a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

Shares in CytoDyn added 1.18% to US$3 each.

----Updates for share price---

Contact the author at [email protected]

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Price: 5.215 USD

OTCQB:CYDY
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Market Cap: $2.71 billion
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