CytoDyn Inc (OTCMKTS: CYDY) is in full beast mode skyrocketing up the charts on record setting volume easily surpassing all 3 moving averages and headed for a blue sky breakout. The shorts managed to stop CYDY at $10 the last time but Cytodyn is much stronger now than it was back then. There could not be a more exciting time to own Cytodyn as leronlimab demonstrates significant potential to attack a number of diseases including cancer, HIV and coronavirus. CMS just provided a DRG Code for leronlimab so Medicare and Medicaid can reimburse for leronlimab starting after January 1 if it is approved which seems more and more likely every day. The FDA has been following the leronlimab trials carefully.
Investors are gearing up for the webcast with CYDY brass on Thursday at market close. Management will provide an update on recent clinical and regulatory developments regarding COVID-19 clinical trials, along with other strategic priorities. Thursday’s conference call should shed some more light on realistic time frames for a possible EUA or full approval. An up list to NASDAQ which is back on the table here could result in a massive short covering rally.
CytoDyn Inc (OTCMKTS: CYDY) is a late stage biotech developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications. CCR5 plays a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals and clinics throughout the U.S., which are identified on the Company’s website under the “Clinical Trial Enrollment” section of the homepage; an interim analysis on the first 195 patients was conducted mid-October and is expected to occur again now that the Company has reached enrollment of 293 patients.
On November 23 CYDY reported it has reached enrollment of 293 patients in its Phase 3 trial for COVID-19 patients with severe-to-critical symptoms, thereby meeting the requested criteria for a second interim efficacy analysis by the Data Safety Monitoring Committee (DSMC). After the first interim analysis, the DSMC requested a second interim analysis of all data after enrollment had reached 293 patients or 75% of the total patients for the trial. Approximately five weeks ago, the DSMC completed the first interim analysis on 195 patients (or 50% of the 390 planned patients) and recommended the trial continue without modification to achieve the primary endpoint and requested another interim analysis when enrollment reached 75% level (or 293 patients) to review patient mortality and other clinical outcome data.
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CytoDyn also signed an agreement with amfAR, The Foundation for AIDS Research to test the ability of Vyrologix (leronlimab) to mediate a functional HIV cure. The international organization, amfAR, plays a vital role in AIDS research by identifying critical gaps in the knowledge of HIV and AIDS and supporting groundbreaking studies.
On December 3 CytoDyn announced Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer, will host an investment community webcast on Thursday, December 10, 2020. Management will provide an update on recent clinical and regulatory developments regarding COVID-19 clinical trials, along with other strategic priorities. Management will also provide approximately 30-45 minutes to address questions submitted online by analysts and investors. The call starts market close at 4pm ET. Prior to the webcast, questions can be submitted online to CYDY_Team@cytodyn.com. This is a “listen only” webcast, which can be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days.
CYDY CEO Nader Pourhassan, Ph.D stated recently: “In addition to filing our biologics license applications in Canada and the U.K. for HIV, the Company is in full swing to obtain full enrollment in the Phase 3 COVID-19 trial before year end and initiate our Phase 2 trial for COVID-19 patients with multiple long-hauler symptoms and perhaps complete enrollment in 4-6 weeks. On another front, CytoDyn is also about to enroll its first patient in the NASH trial this month. We are very appreciative of the all-out effort by our clinical operations team (especially Mr. Brian Brothen, the Company’s SVP of Global Oncology, and Dr. Kush Dhody from Amarex) and the clinical sites to expedite enrollment in this important trial and are hopeful the DSMC can complete their second interim analysis as quickly as possible. We continue to advance enrollment, without any pause to achieve the trial’s planned 390 patients and we are currently evaluating the ability to conduct an interim analysis as soon as possible. In the meantime, if the pace of enrollment we have experienced in the last two weeks continues, we will have the CD12 enrollment completed before the end of the year. These are exciting times for the Company and I am honored to be working alongside such dedicated co-workers.”
— Roberto (@Elektro4future) December 8, 2020
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CYDY is in full beast mode skyrocketing up the charts on record setting volume easily surpassing all 3 moving averages and headed for a blue sky breakout. There could not be a more exciting time to own Cytodyn as leronlimab gains serious traction on numerous fronts. It has been hailed as a wunderdrug for very good reason and its benign safety profile sets it apart from other therapies. Leronlimab provides therapeutic benefit to a large subgroup of covid patients with serious respiratory distress by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in these patients. CMS just provided a DRG Code for leronlimab so Medicare and Medicaid can reimburse for leronlimab starting after January 1 if it is approved which seems more and more likely every day. The FDA has been following the leronlimab trials carefully. The government would not take this pre-emptive DRG designation action to be ready to reimburse for leronlimab if FDA did not think the likelihood of a leronlimab EUA were not promising given the success with CD010 and 60 eINDs. In addition to filing its biologics license applications in Canada and the U.K. for HIV, the CytoDyn is in full swing to obtain full enrollment in the Phase 3 COVID-19 trial before year end and initiate its Phase 2 trial for COVID-19 patients with multiple long-hauler symptoms. On another front, Cytodyn recently reported the first patient first visit metric was met for the Company’s Phase 2 clinical trial for the treatment of nonalcoholic steatohepatitis (NASH). The Phase 2 trial is designed to test whether leronlimab may inhibit the devastating liver fibrosis associated with NASH. The Company’s preclinical study demonstrated strong positive data highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to NASH. 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.