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Sunday, September 25, 2022

Leronlimab; CytoDyn Inc (OTCMKTS:CYDY) Rising Fast as Game Changer Meeting with MHRA Looms

CytoDyn Inc (OTCMKTS:CYDY) is rocketing up the charts after the MHRA; the Medicines & Healthcare product Regulatory Agency of the U.K. government requested a meeting with CytoDyn on September 9, 2020 to discuss the Company’s request for Fast Track approval of leronlimab to treat COVID-19 patients with mild-to-moderate symptoms based upon the trial’s Top-line Report and additional eIND data. On the suggestion of the MHRA, CytoDyn will submit its current Phase 3 CD12 study for severe-to-critical COVID-19 patients in the UK to the Urgent Public Health (UPH) Research scheme to receive possible financial support from the trial sites and the government, if the UPH deems the Company’s CD12 trial an urgent health issue.

CYDY is the darling of small caps and the most exciting stock on the exchange as it rockets upwards in recent days as its wunderdrug leronlimab continues to demonstrate significant potential to attack a number of diseases including cancer, HIV and coronavirus (COVID-19). CYDY is currently focused on up-listing its shares to the NASDAQ stock exchange which could result in a massive short covering rally especially as the short position has increased significantly in recent months. The meeting with MHRA on Wednesday is significant for Cytodyn; an approval in the UK would be the catalyst for Leronlimab to get noticed everywhere else as well as forcing the hand of the FDA.

CytoDyn Inc (OTCMKTS:CYDY) operating out of its principal business offices at 1111 Main Street, Suite 660, Vancouver, Washington, Cytodyn is a late-stage biotechnology company focused on the clinical development and potential commercialization of leronlimab (PRO 140), a CCR5 antagonist that continues to demonstrate significant potential to attack a number of diseases including cancer, HIV and coronavirus (COVID-19). Cytodyn has received conditional acceptance by the FDA of the proprietary name Vyrologix for leronlimab as a combination therapy for highly treatment experienced HIV patients in the United States. In addition, the Company has also received a notice of allowance from the U.S. Trademark Office for the trademark “Vyrologix”.  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 has completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. and submitted the trial’s Top-line Report to the U.S. FDA for emergency use approval and to the U.K. MHRA to request Fast Track Approval. While enrollment continues in its Phase 3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the U.S., an interim analysis on the first 195 patients will be performed in approximately four weeks with results anticipated in mid-October.

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CYDYLeronlimab has shown excellent results in patients having respiratory complications from COVID-19 providing therapeutic benefit by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in these patients. Patients on leronlimba continue to demonstrate a significant improvement in several important immunologic bio-markers.  Patient test data reveals improvement in cytokines, IL-6, and a trend toward the normalization of the CD4/CD8 ratio.

The FDA has advised CytoDyn it has scheduled a Type A meeting on Tuesday following the Company’s receipt of the agency’s written responses on September 1 concerning it Biologic License Application (BLA) for leronlimab as a combination therapy for highly treatment-experienced HIV patients. The FDA clarified the items it needed primarily related to dosage levels.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very encouraged by the MHRA’s considering fast track approval of leronlimab and granting us a meeting. In this meeting, CytoDyn will present a summary of its BLA for HIV in conjunction with our request for fast track approval for COVID-19 indication. We are also grateful to the MHRA for advising us about potential financial support from the sites and UK government for our CD12 study currently in process. We also look forward to meeting with the FDA to help expedite the resubmission of our BLA, as well as learning whether we receive Emergency Use Approval for leronlimab for COVID-19 or, alternatively, are required to proceed with a Phase 3 trial. Regardless, we are working diligently to ensure the availability of leronlimab worldwide to provide a potential benefit for patients infected with this terrible disease.”

Leronlimab has been getting noticed by mainstream press:

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CYDY is back in beast mode running northbound with strength and power after the MHRA requested a meeting with CytoDyn on Wednesday to discuss the Company’s request for Fast Track approval of leronlimab to treat COVID-19 patients with mild-to-moderate symptoms. On the suggestion of the MHRA, CytoDyn will submit its current Phase 3 CD12 study for severe-to-critical COVID-19 patients in the UK to the Urgent Public Health (UPH) Research scheme to receive possible financial support from the trial sites and the government. CytoDyn is among the first biotechs to have a drug that is showing to be effective in the global fight against coronavirus world epidemic. CytoDyn recently completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. While enrollment continues in its Phase 3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the U.S., an interim analysis on the first 195 patients will be performed in approximately four weeks with results anticipated in mid-October.  If the results are better than remdesivir or dexamethasone, pressure will be intense to approve it for sale. CytoDyn is focused on up-listing its stock to the NASDAQ stock market exchange which could result in a massive short covering rally especially as the short position has increased significantly in recent months. The meeting with MHRA on Wednesday is significant for Cytodyn; an approval in the uK would be the catalyst for Leronlimab to get noticed everywhere else as well as forcing the hand of the FDA. We have been reporting on CYDY since the stock was twenty five cents. 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.

Ali Raza
A journalist, with experience in web journalism and marketing. Ali holds a master degree in finance and enjoys writing about cryptocurrencies and fintech. Ali’s work has been published on a number of cryptocurrency publications.

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