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Tuesday, August 3, 2021

Comeback Time for CytoDyn Inc (OTCMKTS:CYDY) NP Talks BLA for the USA, UK and Canada

CytoDyn Inc (OTCMKTS:CYDY) is making an explosive move up the charts since a brief dip below $1.70 per share. New coronavirus cases have been spiking in the US and globally proving the virus is here to stay and won’t be disappearing anytime soon. At the same time results and data coming back from the Pfizer vaccine and Lilly Mab are looking less and less promising the more we learn. This has created a perfect storm for promising biotechs such as Cytodyn who is developing real solutions for the coronavirus pandemic.

CYDY is easily the most exciting stock in small caps that is currently in beast mode after the Company completed a second non-dilutive $28.5 million convertible note financing with conversation rate at $10 per share to expedite licensing applications here and abroad and successful covid-19 trials. CYDY skyrocketed to $10.01 per share earlier this year from a start point of pennies as its wunderdrug leronlimab has continuesd to demonstrate significant potential to attack a number of diseases including cancer, HIV and especially coronavirus. CYDY has attracted a significant short position in recent months which could create another parabolic storm as Cytody once again rises up. Microcapdaily has been reporting on CytoDyn since the stock was trading for pennies.

CytoDyn Inc (OTCMKTS:CYDY) operating out of its executve offices at 1111 Main Street, Suite 660, Vancouver, Washington, 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 believes in the future of precision medicine, more specificity, less side effects. The Company’s target, the CCR5 receptor, has been implicated in multiple disease processes from HIV, GVHD, NASH, stroke recovery, multiple sclerosis, Parkinson’s disease, to metastatic cancer and covid-19. Leronlimab, a CCR5 antagonist, is a once a week, subcutaneous injection. One molecule with multiple opportunities. With precision comes the opportunity for improved safety, convenience, and enhanced efficacy for the patient.

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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In October Cytodyn reported the (MHRA) in the UK has cleared CytoDyn to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistance HIV patients in the U.K. The MHRA’s clearance for the BLA filing included a treatment regimen of one injection per week of 350 mg of the Company’s product leronlimab, as contrasted to the dosage used in the Phase 3 clinical trial conducted in the U.S. for this indication of two consecutive injections of 175 mg per week. During a recent 2-hour meeting between the CytoDyn BLA team and the MHRA, the parties discussed in detail the primary components of the BLA filing: non-clinical, clinical and manufacturing. In connection with the manufacturing section, the Company confirmed it had the necessary one-year of stability data for a 350 mg dose of leronlimab for patients in need of this treatment.

In another huge vote of confidence in Leronlimab, Cytodyn just completed a second non-dilutive $28.5 million convertible note financing with conversation rate at $10 per share without warrants to expedite licensing applications here and abroad and successful covid-19 trials.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very pleased with the institution’s demonstration of confidence and their understanding of leronlimab’s positioning on its regulatory trajectory. This infusion of capital will enable us to accelerate efforts to file BLAs in Canada and the U.K. for leronlimab as a combination therapy for HIV patients with one dose (one 350 mg subcutaneous injection) per week. We continue to expedite enrollment in CD12 (currently at 260 patients), in addition to now accelerating a COVID-19 trial for long-hauler patients, who have no alternative therapy and are rapidly emerging as a widespread health concern. We are well-positioned to supply $2 billion worth of leronlimab to treat COVID-19, if emergency use authorization is approved in the next 2-4 months based on anticipated successful CD12 results.”

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CYDY is heating up and running northbound with power after the Company completed a second non-dilutive $28.5 million convertible note financing with conversation rate at $10 per share to expedite licensing applications here and abroad and successful covid-19 trials. CytoDyn is among the first biotechs to have a drug that is showing to be effective in the global fight against coronavirus. Leronlimab has shown outstanding 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.  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., Cytodyn has also been making some big moves lately including getting BLA expert Mahboob U. Rahman, M.D., Ph.D., FACR, on board as Chief Scientific Officer. CYtodyn CEO CEO Nader Pourhassa stated today on the $28.5 million financing: “With this money we now have the financing in place where this can be the last financing we ever need if we get emergency use authorization quickly, if not we can do another one of these $25 million dollar financings and we believe we are there. We are filing BLA for the USA, UK and Canada and we have multiple chance at covid-19 so this raise could be the very last.” 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.

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