Good stuff . The third expected EUA is from Cyto
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Posted On: 12/08/2020 10:22:58 PM
Good stuff .
The third expected EUA is from CytoDyn Inc. (OTCMKTS: CYDY). This is a repurposed monoclonal antibody that is the only remaining phase 3 drug candidate with a mortality benefit that has not had to resize its study after meeting an interim checkpoint. This drug has a stellar safety profile with over a thousand patients and no SAE’s related to the drug. It is an anomaly because leronlimab showed it actually reduced the side effects over placebo by as much as 60% in a phase 2 mild to moderate study. Now that’s a safe drug! The company is hosting an investor update on Thursday December 10, 2020 and may be close to finishing its trial.
Merck (NYSE:MRK) just did an acquisition of private company OncoImmune for $425 million to get access to their COVID-19 drug. In September they did a $56 million Series B financing to support its Phase 3 COVID-19 drug candidate CD24Fc. OncoImmune’s drug was designed to regulate the inflammatory process in Graft versus Host Disease (GvHD) but was aptly repurposed to fight the cytokine storm in COVID-19. In their interim trial results they showed an impressive 6 day median recovery time versus 10 days in the placebo group.
Investment Summary
There are winners and losers in the drug development process, but it’s hard to ignore a 100% correlation to COVID-19 EUA approvals. Investors owe Rhonda a great deal of gratitude for breaking the news although it’s not clear if she knows how to monetize her findings. For investors it’s pretty clear that a MRNA and PFE approvals are baked into their respective stock prices which means MRK and CYDY are the ideal candidates to speculate on. Merck has been basing for a while but its $425 million purchase price doesn’t exude confidence that they are going to be able to monetize OncoImmune. The odds are good that MRK will rise a little if they get approval which makes it a safe bet with more upside versus downside risk.
CYDY on the other hand seems to have a lot more going for it. First off, it’s a better drug than CD24Fc with respect to GvHD based on its theoretical MOA in COVID-19. The cytokine storm is quieted down in 3 days in ALL COVID-19 patients that take leronlimab. This is an impressive feat but beyond that leronlimab seems on track to meet its mortality endpoint. Many investors are expecting the severe to critical clinical trial to be completed in the next couple of weeks. This could be a major catalyst as investors flock back into this name for fear of missing a runaway freight train that may be the next drug to not only get and EUA but all get full marketing approval. CYDY has a rolling BLA and therefore is quite eligible for approval. The CEO of CytoDyn had indicated that COVID-19 sales could top $7 billion next year. Based on 1 times COVID sales that works out to a $12.00+ stock price and represent a 5x return in the short term. CYDY is quite undervalued and given the very strong correlation of EUA approved drugs that make it to this list it should be aggressively purchased going into the shareholder update.
The third expected EUA is from CytoDyn Inc. (OTCMKTS: CYDY). This is a repurposed monoclonal antibody that is the only remaining phase 3 drug candidate with a mortality benefit that has not had to resize its study after meeting an interim checkpoint. This drug has a stellar safety profile with over a thousand patients and no SAE’s related to the drug. It is an anomaly because leronlimab showed it actually reduced the side effects over placebo by as much as 60% in a phase 2 mild to moderate study. Now that’s a safe drug! The company is hosting an investor update on Thursday December 10, 2020 and may be close to finishing its trial.
Merck (NYSE:MRK) just did an acquisition of private company OncoImmune for $425 million to get access to their COVID-19 drug. In September they did a $56 million Series B financing to support its Phase 3 COVID-19 drug candidate CD24Fc. OncoImmune’s drug was designed to regulate the inflammatory process in Graft versus Host Disease (GvHD) but was aptly repurposed to fight the cytokine storm in COVID-19. In their interim trial results they showed an impressive 6 day median recovery time versus 10 days in the placebo group.
Investment Summary
There are winners and losers in the drug development process, but it’s hard to ignore a 100% correlation to COVID-19 EUA approvals. Investors owe Rhonda a great deal of gratitude for breaking the news although it’s not clear if she knows how to monetize her findings. For investors it’s pretty clear that a MRNA and PFE approvals are baked into their respective stock prices which means MRK and CYDY are the ideal candidates to speculate on. Merck has been basing for a while but its $425 million purchase price doesn’t exude confidence that they are going to be able to monetize OncoImmune. The odds are good that MRK will rise a little if they get approval which makes it a safe bet with more upside versus downside risk.
CYDY on the other hand seems to have a lot more going for it. First off, it’s a better drug than CD24Fc with respect to GvHD based on its theoretical MOA in COVID-19. The cytokine storm is quieted down in 3 days in ALL COVID-19 patients that take leronlimab. This is an impressive feat but beyond that leronlimab seems on track to meet its mortality endpoint. Many investors are expecting the severe to critical clinical trial to be completed in the next couple of weeks. This could be a major catalyst as investors flock back into this name for fear of missing a runaway freight train that may be the next drug to not only get and EUA but all get full marketing approval. CYDY has a rolling BLA and therefore is quite eligible for approval. The CEO of CytoDyn had indicated that COVID-19 sales could top $7 billion next year. Based on 1 times COVID sales that works out to a $12.00+ stock price and represent a 5x return in the short term. CYDY is quite undervalued and given the very strong correlation of EUA approved drugs that make it to this list it should be aggressively purchased going into the shareholder update.
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