CytoDyn Inc (CYDY) Stock Unable To Sustain At Higher Level: Here is Why
After having gone through a pretty rough week, the CytoDyn Inc (OTCMKTS:CYDY) stock managed to make a bit of a recovery on Friday. Last Friday, the stock went up by 7%, however, that was not enough to save the CytoDyn stock from recording a 10% loss for the week.
This morning investors might be interested in the fortunes of the CytoDyn stock and hence, it might be a good move to track it. There was no much news about the company last week but in this context, it might be a good move to take a look at development from earlier on this month. This relates to the five-day proceedings that took place between ProstaGen and CytoDyn, which was related to 3.1 million CytoDyn shares that were held in escrow for some indemnities.
However, in relation to this situation, it was announced earlier in the month that a direct financial obligation had been created that is going to stay off the CytoDyn balance sheet.
Back on June 21, the company had also made a key announcement with regards to its product leronlimab, which has the potential of treating multiple conditions. CytoDyn revealed the preliminary results after it managed to unblind the necessary data from the clinical trial related to the treatment of COVID 19 patients. During the course of the trial, the efficacy and safety of the product were being ascertained. The publication of these results proved to be another considerable boost to the company.
CytoDyn (CYDY) Stock Moves Up: Will The Bounce Back Continue?
The CytoDyn Inc (OTCMKTS:CYDY) stock has seen considerable action this week owing to the events of the week so far but on Thursday, it managed to recover a bit.
The company got a major setback earlier on this week after the United States Food and Drug Administration dished out a public rebuke to CytoDyn and alleged that it had cherry picked data in order to show that its product leronlimab was effective treatment for COVID 19 patients. Following that, the stock had crashed and had recorded declines of as much as 30%. However, on Thursday, the stock managed to mount a recover and went up by 13%.
In this regard, it is necessary to note that CytoDyn also made a key appointment this week and that might have resulted in restoring some degree of confidence among investors.
The company appointed Antonio Migliarese as the new Treasurer and Chief Financial Officer. In this regard, it should be noted that Migliarese had been serving as CytoDyn’s Vice President, Corporate Comptroller prior to this appointment. He will be replacing Michael D. Mulholland, who is going to serve as the vice president of finance at CytoDyn from on.
While this appointment seems to have been welcomed by the market, a bizarre chapter was opened in the company’s current run in with the FDA. Earlier on this week, the Chief Executive Officer of CytoDyn Nader Pourhassan urged the company’s investors to stop badmouthing and trashing the FDA. The statement from the FDA with regards to the clinical trial of leronlimab had clearly not impressed the company’s investors.
The CEO stated that all the badmouthing should be directed at him and requested investors to desist from abusing the agency in any way. The FDA had earlier stated that it had been forced to make a public statement about leronlimab primarily due to the considerable public interest in the product.
CytoDyn Inc (CYDY) Stock Slips Below $2: Time To Buy?
The CytoDyn Inc (OTCMKTS:CYDY) stock went into a meltdown yesterday after the company got a stinging rebuke from the United States Food and Drug Administration.
On Monday, the FDA rebuked CytoDyn for having been selective with regards to the selection data from the two studies of its COVID 19 treatment leronlimab. The FDA alleged that the company tried to show that the product was effective against COVID 19. Both those studies had in fact been failures.
It goes without saying that the development was a major setback for the company and that was reflected in the price action in its stock as well. The CytoDyn stock tanked by as much as 27% yesterday as investors rushed for the exits.
Earlier on this year in March, the Phase 3 clinical trial of leronlimab had been a failure as the product failed to demonstrate its primary target of reducing the effects of symptoms. It failed to meet all the secondary goals as well.
However, CytoDyn decided to turn its focus on 62 seriously ill COVID 19 patients, who had been given mechanical ventilation and concluded that leronlimab helped in reducing all cause mortality by as much as 24%. The company went on to state that the product could also reduce hospitalisation by six days.
The FDA is usually known for being silent when it comes to products which are not approved, but in an unprecedented move the agency dished out a public rebuke to CytoDyn. The agency said that none of the analyses that had been conducted by CytoDyn had been statistically significant.
The agency also stated that the data did not reveal anything that could support the clinical benefits of leronlimab when it comes to the treatment of COVID 19 patients. The agency also stated how clinical trials work which must have come as a further source of embarrassment for CytoDyn.
CytoDyn (CYDY) Stock Extends Fall: Fall Another 10%
For the past couple of years, biotech firm CytoDyn (OTCMKTS:CYDY) has come into prominence due to its work with leronlimab, which is known to work against a range of conditions.
On Wednesday, the CytoDyn stock was in action but it actually recoded a decline of as much as 10%. There was no new about the company yesterday that could have led to the decline. However, in this sort of a situation, it could be a good idea to take a look at some recent development. Back on May 6, the company announced that it was on the verge of starting the trial of leronlimab in patients who were suffering from severe symptoms of COVID 19.
The trial is going to be conducted in collaboration with the academic research organisation Albert Einstein Israelite Hospital (AEIH). The trials are going to be conducted at as many as 45 clinical sites all across the United States. In this regard, it is necessary to note that the Phase III trials are expected to deliver the data that is going to be required by ANVISA, the regulatory body in Brazil, for approving leronlimab for the treatment of COVID 19 infected patients in the country.
It was also announced that CytoDyn is looking to have an interim analysis of the data through October and November. The trial is going to enroll 120 patients suffering from critical symptoms of COVID 19. Last month, the company had announced that it signed an exclusive supply and distribution agreement with Chiral Pharma Corporation. By way of this agreement, CytoDyn is going to supply Chiral with as many as 200000 vials of leronlimab that are going to be administered to critically ill COVID 19 patients in Philippines. These are all important developments and despite the fall in the CytoDyn stock yesterday, investors could consider tracking the stock.