web analytics
14.6 C
Munich
Sunday, September 25, 2022

Bulls Take Charge of CytoDyn Inc (OTCMKTS:CYDY) as Leronlimab Gains Traction

CytoDyn Inc (OTCMKTS:CYDY) is moving northbound in recent trading as the Company continues to announce promising results for Leronlimab as a treatment for coronavirus. Last week the Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the Company to enroll for its ongoing Phase 3 COVID-19 trial for severe-to-critical patients in the United Kingdom. The MHRA’s decision follows several months of its review of CytoDyn’s manufacturing processes and Leronlimab’s safety profile. This comes as CytoDyn has completed its Top-line Report from its randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms to the U.S. FDA, and requested emergency use approval.

CYDY is among the most exciting and dynamic stories on the OTCQB that became the darling of small caps as it 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). CytoDyn is focused on up-listing its stock to a national exchange which could result in a massive short covering rally.

CytoDyn Inc (OTCMKTS:CYDY) is a late-stage biotechnology company with executive offices in Vancouver, Washington, 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). Leronlimab has been granted a Fast Track designation by the FDA for 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. In total Leronlimab has completed 10 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).

Last week CytoDyn announced it has provided its Top-line Report from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms to the U.S. Food and Drug Administration (FDA), and requested emergency use approval. In addition, CytoDyn sent its Top-line Report of the Phase 2, mild-to-moderate COVID-19 population, to the regulatory authorities in Mexico and hopes to obtain emergency use approval from the MHRA in the U.K., EMA in the European Union, as well as the regulatory authorities in the Philippines. CytoDyn has also been approached by several doctors about a clinical study of leronlimab in long-hauler COVID-19 individuals. The Company is preparing a Phase 3 protocol and will file it as soon as possible.

To Find out the inside Scoop on CYDY Subscribe to Microcapdaily.com Right Now by entering your Email in the box below

CYDY

CytoDyn said it will conduct its Type A meeting in writing in lieu of a teleconference with the FDA. which has agreed to respond to the Company’s questions by September 4, 2020 concerning the additional information the FDA requires to resubmit the Biologics License Application (BLA) for leronlimab as a combination therapy for HIV. Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We completely understand and appreciate the FDA’s meeting schedule during these unprecedented times and are eager to discuss and provide all additional information regarding our recent BLA filing.  Our questions to the FDA were submitted on a Type A meeting request and the Agency’s response to those questions will ensure we have the necessary information we need to resubmit the BLA as soon as possible.”

On August 20 CYDY announced the Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the Company to enroll for its ongoing Phase 3 COVID-19 trial for severe-to-critical patients in the United Kingdom. The MHRA’s decision follows several months of its review of CytoDyn’s manufacturing processes and leronlimab’s safety profile.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very pleased with the MHRA’s confidence in Leronlimab to initiate enrollment of patients in the U.K. for our current CD12 protocol. CytoDyn recently requested “fast track approval” from the MHRA for its completed Phase 2 COVID-19 trial for the mild-to-moderate population, with strong efficacy and safety data. We believe Leronlimab has multiple opportunities for several clinical indications and we are very optimistic about our future based upon how far we have advanced this drug in about 5 years. In addition, we plan to file a BLA for HIV in the U.K. within the next 4 weeks.”

For more on CytoDyn Subscribe Right Now!

CYDY is moving northbound since a brief dip below the $3 mark.  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. Leronlimab is proving to be a safe and effective drug to treat m/m covid patients and the P2 study subgroup analysis also demonstrated that the patients with more symptoms at baseline (ie: sicker patients), those who received leronlimab had more of a treatment effect than those receiving placebo. This, along with the decrease in SAEs in leronlimab arm compared to placebo, gives us a peek into the S/C results. Last week the Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the Company to enroll for its ongoing Phase 3 COVID-19 trial for severe-to-critical patients in the United Kingdom. The MHRA’s decision follows several months of its review of CytoDyn’s manufacturing processes and Leronlimab’s safety profile. This comes as CytoDyn has completed its Top-line Report from its randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms to the U.S. FDA, and requested emergency use approval. If the results are better than remdesivir or dexamethasone, pressure will be intense to approve it for sale. 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.

Subscribe to Our 100% Free Penny Stock Newsletter. We Have Something Big Coming!

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

More articles

2 COMMENTS

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Latest article

Sign up now for our 100% FREE Penny Stock Newsletter

Privacy Policy. we will never share your email with anyone.