E Is There A Light At The End Of The Tunnel For A COVID-19 Therapeutic?

The corporate culture of CytoDyn Inc. (CYDY) has created an atmosphere where management is now able to realize the full potential of a drug that was essentially tossed in the garbage heap. That’s right, CytoDyn’s lead drug leronlimab was purchased from Progenics 8 years ago for only $3.5 million and it included all indications like HIV, cancer, stroke, Alzheimer’s Disease, Parkinson's Disease, Graft versus Host Disease (GvHD), NASH, and Multiple Sclerosis (MS). It’s hard to believe that Progenics spent over $200 million on leronlimab before the sale to CytoDyn.Leronlimab is quite safe, and has proved itself beyond a shadow of doubt in multiple indications, and is on the verge of FDA approval. Will the FDA finally approve it or will history repeat itself and tie it up in nonsensical bureaucracy? 


The Unlikely Journey

Leronlimab has survived the most unlikely of journeys and is at the finish line for approval in COVID-19. This is an unbelievable story because not one person could have predicted 8 years ago that leronlimab would be approved let alone take dying from COVID-19 off the table except CytoDyn’s dynamic CEO, Nader Pourhassan.In fact, leronlimab is the only pivotal phase 3 therapeutic candidate for COVID-19 that has mortality as its endpoint. 

The incredibly good reading from a recent Drug Safety Monitoring Committee (DSMC) said leronolimab was on track to meet its primary endpoint of a statistically significant reduction of mortality in its pivotal study. The study was just unblinded to the FDA yet there has been no public action as of yet. This is a drug that is non-toxic and has the potential to dramatically reduce the number of deaths from COVID-19. Despite the fact that the drug “does no harm” it is still sitting in clinical trials awaiting the recruitment of 140 more patients. Thousands of American lives could be saved daily if the FDA would green light leronlimab with an Emergency Use Authorization (EUA). Nothing can legitimately explain why a safe and effective drug has not been made widely available to the masses except politics and bureaucracy. Now that the election is over there is hope that the FDA will do the right thing and cut through the red tape and get this therapeutic in the hands of Americans before the United Kingdom takes all available inventory. The MHRA is considering approval via a BLA filing. 


The Series of Unfortunate Events

At the onset of CytoDyn’s development, a $28 million NIH funding was actually scrapped to pursue a multi drug resistant HIV indication with eyes on the final prize of a monotherapy for HIV patients in the form of a once a week injectable. Even in its infancy of development, HIV monotherapy was the vision of the company, and sure enough results confirmed as much. 

FDA Penalty for Running a Successful Trial

In July 2018 the company successfully met its endpoints in its pivotal Phase 3 Combination therapy (CD02) trial and showed a 48% viral suppression rate after 48 weeks. The higher the viral suppression and the longer it is sustained, the better the outcomes. In March 2018, which was 4 months before CytoDyn announced its results, another monoclonal antibody called Trogarzo obtained orphan drug approval with a 43% viral suppression rate after only 24 weeks. CytoDyn’s drug had a much safer profile and seemed to work much better but the FDA had other plans. 

1 2 3 4
View single page >> |

Disclosure: I own shares of this stock.

How did you like this article? Let us know so we can better customize your reading experience.

Comments

Leave a comment to automatically be entered into our contest to win a free Echo Show.
Moon Kil Woong 4 months ago Author's comment

Anne thanks for the question. I'm waiting on solid news due to short speculation that has hurt this stock despite continues progress. It appears the world is becoming aware that they need more that just a vaccine for Covid. Whether CYDY will be part of their solution gives this plenty of upside. Its shocking to see this stock trading where it is.

Anne Davis 5 months ago Member's comment

Any updates on $CYDY?

Moon Kil Woong 7 months ago Author's comment

Here's another article clearing up the science in the recent trial.

seekingalpha.com/.../4414628-new-look-cytodyn-stock-severe-to-critical-covid-19-trial

Moon Kil Woong 7 months ago Author's comment
Moon Kil Woong 8 months ago Author's comment

Management should be more cognizant of how results are portrayed. The results were very good overall. See the article posted that gives better clarity. All is not lost as some argue. Far from it although I am disappointed with the AIDS push being delayed. Also included is the actual results. seekingalpha.com/.../4413470-cytodyn-far-from-failure Results: fintel.io/.../sec-cytodyn-inc-ex991-2021-march-08-18694-876

Samantha Carter 8 months ago Member's comment

Thanks for the updates.

Moon Kil Woong 8 months ago Author's comment

This article clarifies and puts the results in perspective. I too am disappointed in the stocks reaction to decent news.

insiderfinancial.com/.../181154/

Moon Kil Woong 8 months ago Author's comment

Before results were announced shorts pummeled Cytodyn's shares. The results were extremely positive as one following the news. We will continue to follow the drugs approval and continue to question why the FDA keeps letting people die given the far superior results of all these trials allowing for inferior solutions to get the green light. In my mind they are beholden to something besides the science they keep insisting upon.

That doesn't stop the results as far fewer patients die who get he drug. That said I increasingly feel it is just a matter of time before they become aware that approving a drug that helps the sick is the only way out of the Covid nightmare and grant approval of this. In the meantime, they want yet another trial given its stellar results. We will see if the price recovers.

Moon Kil Woong 9 months ago Author's comment

The short mafia has been called out. This article rounds out the shorters and their connection and shows the players. Unfortunately, it doesn't go into their connections to shorting Gamestop and their ties to nefarious platforms to spew their lies and the lawyers who are connected to them to and their stock manipulation. The entire network should be investigated not the small individual investors.

insiderfinancial.com/.../180939/

Flat Broke 10 months ago Member's comment

I tried to buy $CYDY based on your recommendation, but e-trade, which is supposedly commission free, would have charged me a commission. Any idea why? They haven't charged me commissions on any other stocks I've bought through them. I emailed to enquire but never heard back.

Moon Kil Woong 10 months ago Author's comment

They probably are short it because they loaned it out to shorters. Anyways that's my guess. I'm just waiting around for regulatory approvals and the science to clean away the false narrative of the shorters. It could also be they charged it because its not on the Nasdaq exchange yet. They are on a smaller exchange that is why shorters have been messing with it by posting lies.

Flat Broke 10 months ago Member's comment

I don't think e-trade works like that. Your 2nd answer makes more sense. Thanks.

Moon Kil Woong 10 months ago Author's comment

FYI Here's Another Article

https://www.bbc.com/news/health-55574662

Anne Davis 10 months ago Member's comment

Thanks Moon. When will we see another article by you on the topic?

Moon Kil Woong 11 months ago Author's comment

There is rising steady buying on this stock again. With low volume the rise in demand found few sellers sending it sharply higher. A Wall Street article on people suffering Covid taking Leronlimab to deal with the long term effects of Covid came out after the market closed as well which may continue the recent rise in the stock as Covid therapeutics begin to steal the spotlight.

www.wsj.com/.../experimental-drugs-aim-to-treat-long-haul-covid-11608569400

Anne Davis 11 months ago Member's comment

That's good to hear.