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Wednesday, June 29, 2022

Leronlimab: CytoDyn Inc (OTCMKTS:CYDY) The Bull Has Awoken

CytoDyn Inc (OTCMKTS:CYDY) has seen a spectacular rise in recent trading rocketing up over $6 per share. Microcapdaily has been reporting on CytoDyn since the stock was trading for pennies which was not that long ago. CYDY commands the number 1 spot for most traded small cap stock every day and regularly tops $100 million in daily trading volume. For years longs hailed Leronlimab as a possible wonder drug but the stock price went nowhere until coronavirus came along, then CYDY took off. Leronlimab has demonstrated significant potential to attack a number of diseases including cancer, HIV and now coronavirus (COVID-19).

Investors are choosing CYDY as coronavirus continues its deadly march forward infecting 10 million people as of this writing and growing fast. There is no known cure for covid-19 but several treatments have emerged and CytoDyn’s wunderdrug Leronlimab is near the top of the pack with highly positive results coming back.

CytoDyn Inc (OTCMKTS:CYDY) is an emerging biotech developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. Leronlimab has been hailed as a possible wonder drug and has demonstrated significant potential to attack a number of diseases including cancer, HIV and now coronavirus (COVID-19).

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.

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MicroCapDaily has been reporting on CYtoDyn since February 1 when we reported: “CytoDyn Inc (OTCMKTS:CYDY) has seen a spectacular rise in recent months from a starting point of $0.25 back in mid December to recent highs over $1.50 per share. During this time CYDY has transformed from thinly traded to one of the top most traded stocks on the entire small caps regularly topping $5 million per day in dollar volume.

Leronlimab is getting a lot of attention on  #twitter and people are excited:


On june 11 CYDY announced the Company has met its 75 patient enrollment for its Phase 2 clinical trial entitled “Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19.” This Phase 2 trial evaluates clinical improvement of several symptoms over a 14-day period, including changes in multiple clinical baseline metrics after days 3, 7 and 14. The Company expects the evaluation clinical patient data to be available two weeks after the last patient is enrolled. Because there are more patients who have been screened for enrollment, final enrollment is expected to exceed 75.

CEO Nader Pourhassan, Ph.D commented, “Based upon our understanding of clinical outcomes from severe and critically ill COVID-19 patients, we are guardedly optimistic about the potential results from the mild-to-moderate patients. Furthermore, CytoDyn will do an interim analysis of patient data in the Phase 3 trial for severe and critically ill COVID-19 patients and we hope to have these important results in 2 to 3 weeks.”

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CYDY is making that run up the charts longs were dreaming about when the stock was trading for $0.25 and this was not long ago. CYDY commands the number 1 spot for most traded small cap stock every day and regularly tops $100 million in daily trading volume. The Company is among the first biotechs to have a drug that ccould be effective in the global fight against coronavirus COVID-19 world epidemic. leronlimab which has been hailed as a possible wonder drug has been found to have significant potential to attack a host of diseases including cancer, HIV and now coronavirus COVID-19. On June 11 in a cc as well as a press release CydtoDyn said they have filled out the enrollment of the goal of 75 patients in their double blind study of mild-to-moderate cases of their coronavirus trial, and that final enrollment may be as high as 85 or more. Results will come in July. As Thomas Barnard on SA stated “If the results are better than remdesivir or dexamethasone, pressure will be intense to approve it for sale. Moreover, the FDA gave Cytodyn the advice to end its EIND/compassionate use and focus on enrolling patients in its double blind studies, which seems to put an additional burden on the FDA themselves.” The Leronlimab story is starting to get picked up by the national media which could spell doom for the significant short position that has built up in CYDY over the past few months. while there are dozens of big board biotechs looking for a coronavirus treatmen, Leronlimab and CytoDyn keep popping up mainstream press and on TV. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYDY.

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Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.

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