CytoDyn Inc (OTCMKTS:CYDY) is heating up fast on a surge of volume and is heading upwards again after 2 weeks of choppy waters. With the Andrew Lefts short attack now behind it and largely debunked, a new intra-day low established, the Company is now focused on up-listing its stock to the NASDAQ stock market according to a positive CC on Tuesday. Microcapdaily has been reporting on CytoDyn since the stock was trading for pennies which was not that long ago
CYDY is one of the most exciting stocks in small caps that has commanded the top most traded spot for months. The stock skyrocketed to $10 per share from a start point of pennies as its wunderdrug leronlimab continues to demonstrate significant potential to attack a number of diseases including cancer, HIV and coronavirus (COVID-19). An up list to NASDAQ could result in a massive short covering rally.
CytoDyn Inc (OTCMKTS:CYDY) is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CytoDyn;s Leronlimab (PRO 140) has been granted a Fast Track designation by the FDA ffor 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. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country. The Company announced an MOU with the Coordinating Commission of the National Institutes of Health and High Specialty Hospitals of Mexico (NIH) to conduct a COVID-19 clinical trial with leronlimab for severe and critically ill patients, with the potential to collaborate on additional COVID-19 trials. The NIH of Mexico is an organization that coordinates the main institutions of medical care and public research in the country.
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On July 13 CYDY announced it has received a Refusal to File letter from the U.S. Food and Drug Administration (“FDA”) regarding its Biologics License Application (“BLA”) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients. CytoDyn is confident it can provide all information requested by the FDA. The FDA has informed the Company its BLA does not contain certain information needed to complete a substantive review and therefore, the FDA will not file the BLA at this time. CytoDyn intends to request a Type A meeting with the FDA to discuss its request for additional information. The FDA’s request does not require any additional clinical trials to be conducted, rather the Company will conduct additional analysis of completed trials.
CEO Nader Pourhassan, Ph.D., , commented: “We are 100% committed and confident we can provide the necessary information to the FDA as soon as possible. No additional trials will be required and all the information the FDA has requested is obtainable. While we await upcoming results in our two major COVID-19 Phase 2 and Phase 3 trials, we are confident July will be very important month for our shareholders. I understand many of our shareholders are very eager to see these results soon and I welcome the opportunity to answer any questions from our shareholders during today’s conference call held by the Company.”
CytoDyn is planning to lock and unblind the Phase 2 COVID-19 trial data later this week. Periodic safety review by Data Safety Monitoring Committee (DSMC) for ongoing Phase 3 study (severe/critical population) is planned for next week. Both results to be announced in July
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CYDY is moving up in hurry since a brief dip below the $3 mark on Monday Morning. Investors are excited as CytoDyn 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. CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country and results are expected this month. If the results are better than remdesivir or dexamethasone, pressure will be intense to approve it for sale. the Company is now focused on up-listing its stock to the NASDAQ stock market according to a positive CC on Tuesday. Microcapdaily has been reporting on CytoDYn since the stock was $0.25. 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.