Stealth BioTherapeutics Corp (NASDAQ:MITO) FDA Orphan Drug Designation: Investors Are Delighted

One of the stocks to have made a big move on Thursday was that of Stealth BioTherapeutics Corp (NASDAQ:MITO), which ended the day with gains of as much as 31% amidst heavy interest. It is likely that the stock is going to be on focus today as well.

Trading Data

On Thursday, MITO stock soared 31.51% to $0.25 with more than 77.02 million shares traded, compared to volume of 692K shares. The stock moved within a range of $0.2140 – 0.3759 after opening trading at $0.3259.    

Stealth BioTherapeutics Shares Rally following FDA Orphan Drug Designation To Elamipretide For Duchenne muscular dystrophy (DMD)

In this situation, it could be a good idea to perhaps take a look at the development that led to the gains. The company announced yesterday that the Office of Orphan Products Development of the United States Food and Drug Administration had decided to award orphan drug status to elamipretide. The product in question is meant for treating patients who may be suffering from Duchenne muscular dystrophy or DMD.

However, that is not all. The company also announced that the Division of Neurology I at the FDA had also decided to award the request in relation to the pre-IND meeting for the development path of elamipretide. These were all momentous developments and were eventually meant to provide the company with a pathway with regards to elamipretide. It may be a good idea now for investors to add the stock to their watch lists and watch for further developments over the coming days.

Key Quote

“We are pleased that the FDA has recognized the high unmet need for innovative treatments for DMD. We look forward to further discussions with the FDA regarding our development initiatives, which we hope will bring new options to patients suffering from this devastating disease.”

Technical Data

MITO stock is trading below the 20-Day and 50-Day Moving averages of $0.34 and $0.52 respectively. Moreover, the stock is trading below the 200-Day moving average of $0.90.