CytoDyn Inc (OTCQB:CYDY) closed up 10.09 percent on Wednesday at $2.4550, and has been trading in a day range of $2.4900 to $2.2400. CYDY stock has surged over 97% in the last month, with average monthly volume over 2.42M shares. A look at CYDY stock performance over the last three months shows that it is up over 47.01% while average volume for the stock is 2.18M. With a market capitalization of $1.58B, CYDY stock dropped -29.79% in the last 12 months. As a result of being approved to carry out clinical trials in Brazil, CYDY stock soared.
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What did CYDY get approval for?
CytoDyn is a biotech company that is developing leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor, for multiple therapeutic indications. In addition to its role in tumor metastasis and immune-mediated illnesses, CCR5 appears to be implicated in tumor metastasis and NASH. In HIV-infected patients who were heavily treated and had few treatment options, CYDY successfully completed a pivotal Phase 3 study using leronlimab and standard antiretroviral therapy.
In related news yesterday, CytoDyn announced the start of an additional Phase 3 CD16 clinical trial using leronlimab has been approved by Brazilian regulatory authorities, ANVISA (Agencia Nacional de Vigilância Sanitária).
Patients hospitalized with COVID-19 in a critical state and in need of mechanical and invasive ventilation or Extracorporeal Membrane Oxygenation (ECMO) will participate in this study. Approximately 316 patients will be enrolled in the CYDY trial, which will be conducted at 22 research centers. Following enrolment of 40% of patients and completion of the 28-day trial, we will conduct an interim analysis.
CYDY’s first objective for this trial is to enroll as many patients as possible. The study will be conducted by the Academic Research Organization (ARO) Albert Einstein Israelite Hospital (AEIH) in Brazil together with CytoDyn and BIOMM, CYDY’s exclusive partner in Brazil for the commercialization of leronlimab.
The CD12 study found that most patients survived after the first dose of leronlimab after two weeks, and 82% after the second dose. Treatment with leronlimab lasted only two days (day 0 and day 7); among those who resumed treatment after day 14, survival rate declined from 82% to 30%.
How will the CYDY trial work?
Approximately one to two hours after being administered IV, leronlimab will penetrate the body. Loronlimab could take two or three days to be completely absorbed following SQ injection. A critically ill population requires immediate attention. A 30 percent survival benefit (after 28 days) in the leronlimab arm in the previous trial (CD12) could have been achieved if IV administration had been used instead of SQ administration and if four dosages instead of two were used.