In after-hours trade on Monday June 27, 2016 shares of Regulus Therapeutics tanked as much as 60% after the company announced that the FDA had placed their Hepatitis C drug on a clinical hold. It is not a good thing that the company's drug, RG-101 has been placed on a clinical hold. This is because when an event like this happen investors dump the stock first and ask questions later. Thus, the reason why the stock tanked as much as it did in one single day.
Regulus' drug RG-101 is a micro-RNA molecule drug specifically built to halt the activity of Hepatitis C. The way the molecule works is that it regulates the activity of the miR-122, which is found in the liver and is responsible for controlling the amount of Hepatitis C in the body. By Regulus being able to regulate the activity of the miR-122, it believes that it can help cure patients of the Hepatitis C virus.
The company can't do much for the moment, all it can do is that it must await the clinical hold letter from the FDA which is expected to come within a 30-day period. At that time, Regulus can then evaluate the next steps it needs to take in order to lift the clinical hold. The problem is that it will not be that easy of a task in order to get the FDA to release the clinical hold. The reason for the clinical hold being placed is because of one patient experiencing a second serious adverse event of Jaundice.
One patient who had end-stage renal disease with the Hepatitis C virus had a serious adverse event of Jaundice. This patient had received one injection of RG-101, and did not experience this adverse event until 117 days later. While the FDA placing the Hepatitis C trials on clinical hold is bad for the short-term, there is a huge opportunity for investors in this name. That is because is unlikely that RG-101 caused this patient's Jaundice.
Instead, this patients was very ill and it is possible that the Jaundice came about from having the Hepatitis C virus alone. Of course, the FDA must always take a cautious approach thus the reason why they place the clinical hold anyways. The reason for doing so is so they can investigate the matter, and determine that it is not the drug causing the formation of Jaundice. Regulus will have to quickly work to see if it can lift the clinical hold at a quick pace.
While there is an FDA clinical hold in place for the Hepatitis C program, it won't matter for the current clinical trials being done. That is because all patients have already been enrolled and dosed already. That means that the clinical hold will have no effect whatsoever on the ongoing Hepatitis C virus trials. The company expects to update investors about the progress of these clinical trials at an upcoming scientific conference.
In a phase 2 interim data update patients who took 2 injections of RG-101 combined with 4 weeks of oral direct-acting antivirals, showed that 97% of patients were below level detection quantification over an 8-week period. Those patients who took the regimen for 12-weeks saw 100% of the patients below level detection quantification. One thing to note though is that these are HCV patients with the genotype 1 and genotype 4 of the virus.
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Hopefully, Regulus can resolve this matter quickly with the FDA, and the drug can possibly reach the market. Even though there are already a lot of other competitors, Regulus stands a good chance. That is because its drug is an injection that is administered once and not pills that a patient must take everyday. There is plenty of room in the market for RG-101, should it happen to be approved by the FDA.
Regulus' drug RG-101 is a micro-RNA molecule drug specifically built to halt the activity of Hepatitis C. The way the molecule works is that it regulates the activity of the miR-122, which is found in the liver and is responsible for controlling the amount of Hepatitis C in the body. By Regulus being able to regulate the activity of the miR-122, it believes that it can help cure patients of the Hepatitis C virus.
The company can't do much for the moment, all it can do is that it must await the clinical hold letter from the FDA which is expected to come within a 30-day period. At that time, Regulus can then evaluate the next steps it needs to take in order to lift the clinical hold. The problem is that it will not be that easy of a task in order to get the FDA to release the clinical hold. The reason for the clinical hold being placed is because of one patient experiencing a second serious adverse event of Jaundice.
One patient who had end-stage renal disease with the Hepatitis C virus had a serious adverse event of Jaundice. This patient had received one injection of RG-101, and did not experience this adverse event until 117 days later. While the FDA placing the Hepatitis C trials on clinical hold is bad for the short-term, there is a huge opportunity for investors in this name. That is because is unlikely that RG-101 caused this patient's Jaundice.
Instead, this patients was very ill and it is possible that the Jaundice came about from having the Hepatitis C virus alone. Of course, the FDA must always take a cautious approach thus the reason why they place the clinical hold anyways. The reason for doing so is so they can investigate the matter, and determine that it is not the drug causing the formation of Jaundice. Regulus will have to quickly work to see if it can lift the clinical hold at a quick pace.
While there is an FDA clinical hold in place for the Hepatitis C program, it won't matter for the current clinical trials being done. That is because all patients have already been enrolled and dosed already. That means that the clinical hold will have no effect whatsoever on the ongoing Hepatitis C virus trials. The company expects to update investors about the progress of these clinical trials at an upcoming scientific conference.
In a phase 2 interim data update patients who took 2 injections of RG-101 combined with 4 weeks of oral direct-acting antivirals, showed that 97% of patients were below level detection quantification over an 8-week period. Those patients who took the regimen for 12-weeks saw 100% of the patients below level detection quantification. One thing to note though is that these are HCV patients with the genotype 1 and genotype 4 of the virus.
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Hopefully, Regulus can resolve this matter quickly with the FDA, and the drug can possibly reach the market. Even though there are already a lot of other competitors, Regulus stands a good chance. That is because its drug is an injection that is administered once and not pills that a patient must take everyday. There is plenty of room in the market for RG-101, should it happen to be approved by the FDA.
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