DRP Journal

Discover Research Profit

Finance 

Stealth BioTherapeutics Corp (NASDAQ:MITO) Stock Rallies After The FDA News

Jon Williams , , , ,

Stealth BioTherapeutics Corp (NASDAQ:MITO) was up 3% after reporting in the pre-IND meeting with the US Food and Drug Administration’s Division of Cardiology and Nephrology about the Duchene muscular dystrophy development program.

Market Stats

On Monday, MITO stock ended up by 3.89% to $0.8550 with more than 27K shares, compared to its average volume of 174k shares. The stock has moved within a range of $0.8011 – 0.8599 after opening trading at $0.8011.

Stealth BioTherapeutics Reports Positive Pre-IND Meeting for Duchenne Muscular Dystrophy

The company also reached alignment regarding Stealth’s proposal to evaluate myocardial fibrosis progression as a surrogate endpoint for the planned clinical trial. The pre-IND meeting sought to discuss Stealth’s suggested DMD development plan. As a result, the agency agreed that the company should evaluate myocardial fibrosis through MRI utilizing late gadolinium enhancement, which will serve as the primary endpoint of the new clinical study.

Stealth CEO Reenie McCarthy said that they are delighted that the DCN has acknowledged the significance of evaluating myocardial fibrosis in DMD. McCarthy explained that progressive cardiomyopathy could lead to heart failure, which is the main cause of mortality in DMD and is a vital unmet need in the devastating disease. Most importantly, the company will continue engaging DCN about the proposed approval pathway. Therefore MITO is worth watching.

Key Quote

“We applaud DCN for recognizing the importance of assessing myocardial fibrosis in DMD, where progressive fibro-fatty infiltration starting as early as middle childhood is associated with a loss of left ventricular function and adverse cardiovascular events,” said Reenie McCarthy, Chief Executive Officer at Stealth.

Traders Corner

MITO stock is trading below the 20-Day and 200-Day Moving averages of $0.88 and $1.04 respectively. The stock is trading in neutral zone with the RSI at 42.  The stock is down 9% in the past month.

Jon Williams

Jon graduated from the University of Michigan with a degree in finance. He is an avid investor and enjoys reporting on the markets. When he is not in front of a computer he enjoys playing golf and watching basketball.